DIA 2017 Annual Meeting: Full Schedule

8:30am CDT

#23: Signal Detection: Identifying and Managing Safety Signals

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-17-502-L04-P; CME 3.25; IACET 3.25; RN 3.25

Signal detection is an essential element of the overall risk management process. This short course provides a concise review of current methods of drug safety signal detection for marketed products and the role of signal detection within the larger signal and risk management process. Emphasis is on practical pragmatic approaches. Outputs from quantitative signal detection will be the basis for a hands-on exercise and discussion. The short course also provides participants with the context to evaluate new research in the field. Back to DIA 2017

Speakers

James Buchanan

President, Covilance LLC, United States

Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and... Read More →

Sunday June 18, 2017 8:30am - 12:00pm CDT
S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

Short Course, Tutorial | 05: Regulatory, Tutorial

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8:30am CDT

#25: Regulatory Considerations for Drug Development: Current Status and Trend of IND/NDA Practice in China

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-000-17-507-L04-7; CME 3.25; IACET 3.25

The Chinese regulatory landscape seems unique from and harmonious with global standards and practice. Since 2015, Chinese GCP guidelines published by the China Food and Drug Administration (CFDA) have been amended significantly, of which some good clinical practices (GCP) are overturning common ways that were implemented since 2003. The CFDA is updating the drug category and IND/NDA process for the regulatory registration purpose, and enhancing inspective forces on the quality and integrity of clinical trial outcomes. The procedures of IND/NDA review and approval have been greatly reformed. The quality of trial data is becoming more essential as evidence of supporting NDA approval. All of these updates are sure to impact the IND/NDA drug R&D strategies in China. This course will provide insights into critical considerations impacting IND/NDA practices involving drugs development in China and current CFDA reformations of regulatory submission review and approval.

Who should attend?

This short course is designed for professionals in regulatory affairs, drug development, clinical trial management, monitoring, data management or clinical operations who have some basic knowledge of the Chinese regulatory environment and will benefit from learning updates of IND/NDA drug clinical trials.

Learning Objectives

At the conclusion of this course, participants should be able to:

Describe basic CFDA regulatory requirements for an IND/NDA process
Explain Chinese regulatory practice and trends for reviewing and approving submissions of drugs
Discuss the updated Chinese GCP guidelines for IND drug trials
Explain how to be compliant with Chinese GCP standards in the implementation of clinical trials
Complete the IND/NDA application process to the CFDA.

Sunday June 18, 2017 8:30am - 12:00pm CDT
S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

Short Course, Tutorial | 05: Regulatory, Tutorial

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8:30am CDT

#21: Successful Drug Development: Best Practices for Drug Development Planning, Agency Interactions, and Regulatory Document Writing

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-17-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

Understanding best practices is critical as you design a clinical program and regulatory strategy for a drug or biologic product. Identifying and obtaining the data actually needed for a product development program is key to the success of the program. Thinking ahead to the marketing application helps a sponsor avoid many of the common mistakes that are made in overall drug development programs. Even though it may be years before an NDA/BLA/MAA submission, the marketing application is the goal of each development program and should be kept in view throughout the program to avoid pitfalls and delays in submission and product approval. This short course will cover common mistakes and solutions in the areas of drug development planning, regulatory agency interactions, and regulatory document writing. Practical advice for each of these areas will be presented, with an emphasis on learning from past examples that illustrate approaches to adopt or to avoid.

Who should attend?

This short course is designed for professionals with basic knowledge in regulatory affairs, agency submissions, and regulatory medical writing.

Learning Objectives

At the conclusion of this course, participants should be able to:

Identify ways to increase the efficiency and success of product development programs
Describe key principles for successful regulatory interactions during drug development and marketing application preparation
Discuss best practices in developing successful clinical trial designs, statistical analysis plans, and regulatory submission documents

Speakers

Elaine Taylor

Executive Director, Regulatory Consulting and Submissions, INC Research

Elaine B. Taylor is Global Head of Regulatory Consulting and Submissions at INC Research responsible for leading a global team of regulatory professionals providing consultation, development, and management of regulatory interactions and submissions for sponsors. With over 25 years... Read More →

Sunday June 18, 2017 8:30am - 12:00pm CDT
S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

Short Course, Tutorial | 05: Regulatory, Tutorial | 03: MedAffairs-SciComm, Tutorial

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Featured Topics Medical Writing
Credit Type ACPE, CME, IACET, RN
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8:30am CDT

#22: How to Prepare for an FDA Inspection

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

This short course will provide information on how to build quality into a clinical trials program. A record number of FDA inspections, both domestic and international, and OHRP audits have resulted in an increased number of warning letters to sponsors, principal investigators, and IRBs. Using case studies, simulations and actual findings, participants will be able to describe how to approach clinical trials that fully comply with good clinical practice expectations. Participants will also learn about the considerations for non-compliance and the types of findings in an audit that can lead to regulatory problems. This course will describe the role of the FDA and the preparation of a site for an FDA inspection. We will cover the audit from different perspectives and focus on helpful hints and procedural issues regarding what to do in case your site is chosen for an FDA inspection. There will be a discussion on how to host the audit and how best to prepare for the actual audit. The audience will be taught some of the do's and don'ts of a successful inspection. Back to DIA 2017

Speakers

Michael Hamrell

President, MORIAH Consultants

Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in pharmaceuticals, contract research, government and biotech industries, in domestic and international regulatory affairs... Read More →

Sunday June 18, 2017 8:30am - 12:00pm CDT
S401d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

Short Course, Tutorial | 11: Quality, Tutorial | 05: Regulatory, Tutorial

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1:00pm CDT

#30: Preparing for a US FDA Advisory Committee Meeting

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-17-503-L04-P; CME 3.25; IACET 3.25; RN 3.25

What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This short course is structured like an actual FDA Advisory Committee meeting, and presents best practices for preparing for meetings. What You Will Learn:

What an advisory committee is
How an advisory committee is structured
Critical factors for advisory committee preparation
How to design the most applicable preparation program for your team
Top ten "best practices" and "must avoids"

Who should attend?

This course is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

Learning Objectives

At the conclusion of this course, participants should be able to:
- Identify the critical success factors in preparing for an advisory committee meeting
- Outline those factors that are most applicable to your team
- Design the most effective preparation strategy for your team(s)

Speakers

Neelu Agrawal

Principal, PharmApprove, a member of the NDA Group

Neelu has over 20 years of strategic communication, cross-functional leadership and management consulting experience. Prior to PharmApprove, Neelu was a Partner at Rosetta, where she helped lead the company’s healthcare consulting practice. She has worked closely with clinical... Read More →

Pete Taft

Senior Communications Coach, PharmApprove, a member of the NDA Group

Senior Communications Coach, Pete Taft provides strategic counsel and coaching services. He has conducted dozens of “lessons learned” sessions, videoconferences, workshops, seminars and individual coaching sessions. Pete began his career in journalism, covering crime, politics... Read More →

Sunday June 18, 2017 1:00pm - 4:30pm CDT
S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

Short Course, Tutorial | 05: Regulatory, Tutorial

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Credit Type ACPE, CME, IACET, RN
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1:00pm CDT

#33: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-17-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.

Who should attend?

This short course is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Learning Objectives

At the conclusion of this short course, participants should be able to:

Explain the major elements of the Japanese regulatory system
Describe the regulatory procedures during development, registration, and post-approval
Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies

Speakers

Alberto Grignolo

Corporate Vice President, Corporate Strategy and Thought Leadership, Parexel, United States

Alberto Grignolo, Ph.D. FDIA is Corporate Vice President, Corporate Strategy and Thought Leadership at Parexel, and established the Company's Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He is a champion of Diversity, Equity and Inclusion within and... Read More →

Sunday June 18, 2017 1:00pm - 4:30pm CDT
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

Short Course, Tutorial | 05: Regulatory, Tutorial

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11:00am CDT

#114: PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Development and approval timelines for drugs and therapeutic biologic products affect us all. This will be the first reauthorization occurring in parallel with a new Congress and a new administration. This session will focus on how PDUFA has affected both the regulator and regulated industry and what we can expect in the sixth iteration of the agreement.

Learning Objectives

Discuss a historical review of PDUFA from expediting approvals to expediting development; Identify what's new in PDUFA VI and the impact on sponsor and regulator.

Chair

Kim M. Quaintance-Lunn

Speaker

Panelist
Theresa M. Mullin, PhD

FDA Perspective
Patrick Frey

Industry Perspective
Sandra A. Milligan, JD, MD

Panelist
Lucy Vereshchagina, PhD

Moderators

Kim Quaintance-Lunn

Vice President, Regulatory Affairs Americas, Bayer AG, United States

Kim Quaintance-Lunn is the Vice President, Regulatory Affairs Americas and a Distinguished Science Fellow at Bayer, a Director at Large for the FDA Alumni Association, and Chair of DIA's Americas Regional Advisory Council. At Bayer, Kim serves in a leadership capacity for US Regulatory... Read More →

Speakers

Patrick Frey

Chief of Staff, Office of New Drugs, CDER, FDA

Patrick Frey is the Chief of Staff in CDER's Office of New Drugs. He has played leadership roles in the reauthorization of PDUFA V and VI as well as BSUFA II. He was also the CDER lead in developing and implementing CDER's structured framework for benefit-risk assessment. Patrick... Read More →

Sandra Milligan

Senior Vice President, Head of Global Regulatory Affairs and Clinical Safety, Merck Research Laboratories

Sandra Milligan serves as senior vice president and head of Global Regulatory Affairs and Clinical Safety at Merck. She is a graduate of George Washington University School of Medicine and Georgetown University Law Center. Sandy served on DIA’s board from 2011 to 2017, served on... Read More →

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →

Lucy Vereshchagina

Vice President, Science and Regulatory Advocacy, PhRMA, United States

Dr. Vereshchagina is the Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA represents the country’s leading innovative biopharmaceutical research companies, which are devoted to researching and developing medicines... Read More →

Monday June 19, 2017 11:00am - 12:15pm CDT
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
Featured Topics Public Policy
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Featured Topics Public Policy
Credit Type CME, IACET, RN
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11:00am CDT

#115: Update from the CFDA

Component Type: Session
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

In August 2015, China’s State Council issued an document entitled "The Opinions on Reforming Review and Approval Process for Drugs and Medical Devices", unveiling a long-awaited major regulatory reform plan, with five main goals: to improve regulatory review and approval quality, address the drug application backlog, upgrade quality of generic drugs, promote innovative drug research and development, and to enhance regulatory transparency. Since then, many reform measures have been implemented. In this session, members from various organizations in the China Food and Drug Administration (CFDA) in will discuss the major initiatives and progress, as well as the future directions of the regulatory reform in China.

Learning Objectives

Identify and understand the latest CFDA’s activities and initiatives in regulatory reform as well their impacts on Chinese pharmaceutical regulation and enforcement; Recognize China’s evolving regulatory environment and future development.

Chair

Ling Su, PhD

Speaker

CDE Reform Measures
Zhimin Yang, MD

Strengthen Regulatory Enforcement on Clinical Trial Integrity and Data Quality
Rong Zhang, MS

ADR Monitoring in China
Duo Dong

Panelist
Xiaoling Qin

Speakers

Duo Dong

Deputy Division Director, National Center for ADA Monitoring, China Food and Drug Administration (CFDA)

Duo Dong

Deputy Division Director, National Center for ADA Monitoring, China Food and Drug Administration (CFDA)

Xiaoling Qin

Deputy Director General, Department of International Cooperation, China Food and Drug Adminsitration (CFDA)

Zhimin Yang

Division Director, Center for Drug Evaluation, China Food and Drug Administration (CFDA)

Rong Zhang

Deputy Chief Technician, Center For Food and Drug Inspection, China Food and Drug Administration (CFDA)

Zhang Rong, Deputy Chief Technician, have been working for Center for Food and Drug Inspection for 20 years in the field of Medcial Devices inspection, GCP inspection.

Monday June 19, 2017 11:00am - 12:30pm CDT
S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session

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Featured Topics Clinical Operations,Global Regulatory
Credit Type CME, IACET, RN
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10:30am CDT

#217: Update from CBER: Advancing the Development of Complex Biologic Products

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of how the Center for Biologics Evaluation and Research (CBER) works to advance the development of complex biological products such as vaccines, live biotherapeutics, and cellular and gene therapies. The session will include a discussion of how the Center is working to implement relevant provision of the 21st Century Cure Act aimed at further expediting the development of important medical products.

Learning Objectives

Identify regulatory work recently completed or in progress and communicate Center priorities for the coming years.

Chair

Peter W. Marks, MD, PhD

Speakers

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →

Tuesday June 20, 2017 10:30am - 11:30am CDT
S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
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Featured Topics StudentProgramming,Global Regulatory
Credit Type CME, IACET, RN
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10:30am CDT

#218: ClinicalTrials.gov: Complying with Requirements in the Final Rule (42 CFR Part 11) and Impacts of 21st Century Cures Act

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-17-571-L04-P; CME 1.00; IACET 1.00; RN 1.00

The Department of Health and Human Services issued a final rule (42 CFR Part 11), with an April 18, 2017 compliance date, clarifying existing requirements and establishing new requirements for registering and submitting summary results of clinical trials to ClinicalTrials.gov. The 21st Century Cures Act became law in December 2016 and includes provisions related to ClinicalTrials.gov reporting, including stakeholder outreach, reporting of compliance activities, and manufacturer obligations for making available policies about expanded access and linking to ClinicalTrials.gov. This session aims to help clinical trial sponsors understand their legal obligations for submitting registration and results information to ClinicalTrials.gov and the steps taken by NIH under the Cures Act.

Learning Objectives

Describe the requirements in 42 CFR Part 11 for the submission of registration and results information by trial sponsors and investigators to ClinicalTrials.gov, including information on expanded access; Discuss potential consequences of noncompliance with 42 CFR Part 11; Describe NIH obligations under the 21st Century Cures Act related to ClinicalTrials.gov.

Chair

Rebecca J. Williams, PharmD, MPH

Speaker

Perspective From ClinicalTrials.gov
Rebecca J. Williams, PharmD, MPH

Speakers

Rebecca Williams

Acting Director, ClinicalTrials.gov, NCBI, National Library of Medicine, NIH

Rebecca Williams, PharmD, MPH, is Acting Director, ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. She moved into this role after serving as the Assistant Director for over a decade. She is responsible for technical, scientific, policy, regulatory... Read More →

Tuesday June 20, 2017 10:30am - 11:30am CDT
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session

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Featured Topics Public Policy,Clinical Operations
Credit Type ACPE, CME, IACET, RN
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10:30am CDT

#213: Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will provide an overview of the regulatory context for the coming surge of disruptive innovation. We will discuss the challenges involved and explore how FDA and others could collaborate to develop new approaches to facilitate this innovation. We will describe the steps FDA has already begun taking to prepare, as well as lay out where the agency could go further.

Learning Objectives

Explain how disruptive innovations will challenge regulatory frameworks; describe how FDA, companies and patients may approach collaborating to facilitate disruptive innovations such as gene therapy, combination products and microbiome exploration; Explain how regulatory approaches may change in order to accommodate this innovation

Chair

Nancy Bradish Myers, JD

Speaker

Panelist
Richard Moscicki, MD

Gene Therapy Cures: How Will They Break the Mold?
Anne-Virginie L. Eggimann, MS

Panelist
Tal Zaks, MD, PhD

Moderators

Nancy Myers

CEO and Founder, Catalyst Healthcare Consulting, Inc, United States

Nancy Bradish Myers, JD, CEO & Founder, Catalyst Healthcare Consulting, is a sought-after leader with deep expertise in health law, regulation and policy. She has led a successful strategic regulatory policy consultancy for 19 years and has been active in the DC policy arena for three... Read More →

Speakers

Anne-Virginie Eggimann

Senior Vice President, Regulatory Science, bluebird bio, Inc.

Anne-Virginie joined bluebird bio in 2011 to lead global regulatory strategy and create innovative pathways to accelerate the development of bluebird bio’s gene therapy products. Previously, AV was an Executive Director at Voisin Consulting, leading rare diseases, oncology, and... Read More →

Richard Moscicki

Deputy Center Director for Science Operations, OCD, CDER, FDA

Richard (Rich) A. Moscicki (Mo-shis-ke), M.D., joined the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), as Deputy Center Director for Science Operations. A nationally recognized expert in clinical research and development, Dr. Moscicki... Read More →

Tal Zaks

Chief Medical Officer, Moderna Therapeutics, United States

As chief medical officer, Dr. Tal Zaks oversees preclinical development, clinical development and regulatory affairs across Moderna and its ventures. Prior to joining Moderna, Dr. Zaks was senior vice president and head of Global Oncology at Sanofi, where he was responsible for all... Read More →

Tuesday June 20, 2017 10:30am - 11:45am CDT
S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
Featured Topics Rare Disease
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Featured Topics Rare Disease
Credit Type CME, IACET, RN
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10:30am CDT

#214: Recent Trends in Asian Regulations for Drug Development: What is Coming Next?

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Needless to say, Asia is one of the most important and emerging regions in the world and its significance in global drug development is increasing. This session is aiming to give an update on the recent regulatory trends in East Asian countries. Regulatory agencies from major East Asian countries including Japan, Singapore, and Taiwan, together with the industry representation, will give an overview of the recent regulatory environment changes in each country. We will also hear about their effort to promote harmonization of regulations for drug development in this region and discuss actual examples of Asian drug development utilizing multiregional clinical trials in Asian countries.

Learning Objectives

Discuss the most updated regulations for drug development in each Asian country; Discuss how Asia is contributing to worldwide drug development; Describe activities in the Asian region with respect to modernization and harmonization of regulations.

Chair

Akio Uemura, PhD

Speaker

Successful Regional Collaborative Experience in Global New Drug Development: TFDA Perspective
Chao-Yi Joyce Wang, MSc

RecentTrend in Drug Development Regulations of China and Other Asian Countries
Vicky (Fengyun) Han, Esq

The Latest Japanese RegulatorySituations to Promote Drug Development and Advance Regulatory Science
Yoshiaki Uyama, PhD

Moderators

Akio Uemura

Executive Director, Head of Japan Development, Allergan Japan K.K.

1996: Head of biosciences lab, Mochida Pharmaceutical, 2000: Director, project management, EL Japan, 2004: Clinical phase global project manager, Eli Lilly, 2007: Director, regulatory policy, liaison and intelligence, EL Japan. 2011: Head of Japan Regulatory Affairs, Allergan Japan... Read More →

Speakers

Vicky (Fengyun) Han

Senior Director, Asia Pacific Regulatory Policy Group Lead, Asia Pacific, Johnson & Johnson Pte. Ltd.

Vicky Han is Senior Director at Janssen Pharmaceuticals in charge of Asia Pacific Regulatory Policy since 2016. Her experiences spans in Asia & Europe, she dedicated 18 years in GSK, wherein 12 years in GSK China for leading regulatory affairs. In 2008, she moved to Belgium for dealing... Read More →

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science reserach in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →

Chao-Yi Wang

Director, Division of Medicinal Products, Ministry of Health and Welfare, TFDA, Chinese Taipei

Ms. Chao-Yi (Joyce) Wang was appointed as the Director of Division of Medicinal Products, TFDA, Chinese Taipei, Ministry of Health and Welfare on January 7, 2016. She is responsible for management of pharmaceutical policies and regulations, including premarket approval of medicinal... Read More →

Tuesday June 20, 2017 10:30am - 11:45am CDT
N227b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session

Level Intermediate
Featured Topics Global Regulatory
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Featured Topics StudentProgramming,Global Regulatory
Credit Type CME, IACET, RN
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10:30am CDT

#215: The Evolving Model of Using Artificial Intelligence to Deliver Actionable Regulatory Intelligence

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The breadth and scope of a regulatory intelligence function is often dependent on the knowledge of its employees, the tools they can access or the consultants they employ. What if we were able to employ machine learning and cognitive computing to help deliver actionable intelligence? This session will look at evolving models for Artificial Intelligence and the challenges in developing and validating these systems.

Join RA Community, Regulatory Intelligence Working Group for a follow up Round Table discussion at 1:00pm, Wednesday June 21st in the Community Corner.

Learning Objectives

Discuss artificial intelligence concepts, tools, and case studies in the development of actionable regulatory intelligence.

Chair

Linda F. Bowen

Speaker

Advances in Regulatory Intelligence Through Artificial Intelligence: Industry Perspective
Patrick K Brady, PharmD

Enigma Variations: The Use of Artificial Intelligence in Regulatory Decision Making
Tom Macfarlane, RAC

Moderators

Linda Bowen

Senior Director, Global Regulatory Science and Policy, Sanofi

Linda is Senior Director, Global Regulatory Science and Policy at Sanofi, and has held senior positions at Bayer and Block Drug/GSK, with global regulatory responsibilities for submissions, LCM and due diligence. She is an adjunct professor in the Temple University RA/QA Program... Read More →

Speakers

Patrick Brady

Vice President, Regulatory Affairs Head, Regulatory Policy and Intelligence, Bayer AG

Dr. Patrick Brady is Vice President, Regulatory Affairs at Bayer. In this role, he leads Bayer’s global regulatory policy and intelligence activities. He has more than 10 years of experience in Regulatory Affairs. Prior to joining Bayer, Patrick led international science and regulatory... Read More →

Tom Macfarlane

Director, Life Sciences, Accenture Accelerated R&D Services

A Neuroscientist by training, Tom has worked in most therapeutic areas during time at Ipsen, Parexel and as a freelance consultant. Now at Accenture, he continues to represent clients to EMA and to facilitate drug development strategies; but also works with emergent technologies/concepts... Read More →

Tuesday June 20, 2017 10:30am - 11:45am CDT
S404d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session

Level Intermediate
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Credit Type CME, IACET, RN
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10:30am CDT

#216: International Collaboration in Times of Public Health Crisis

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

International collaboration amongst regulators is important from the industry aspiration that it should suffice to develop one global dossier. In the wake of the Ebola crisis, and again during the current Zika event, regulators have and are demonstrating a willingness to find new and pragmatic ways of working together with industry with the ultimate goal of providing health care solutions which are in demand by society. Are there lessons learned that can be shared and discussed? Can the envelope be pushed even further?

Learning Objectives

Describe the current state of cooperation amongst regulators during Public Health Emergencies; Identify the challenges faced by the stakeholders, Discuss lessons learned in addressing the challenges.

Chair

Ian Hudson

Speaker

Crisis Management in the Face of a Global Health Pandemic: How Can We Leverage International Efforts?
Jarbas Barbosa

Update From the FDA
Carmen T. Maher

Update from the EMA
Agnès Saint-Raymond, MD

Moderators

Ian Hudson

Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Dr Ian Hudson became Chief Executive of the MHRA in September 2013. He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. In 2001 he joined the former Medicines Control Agency as its Licencing Division... Read More →

Speakers

Jarbas Barbosa

Director- President, Agência Nacional De Vigilância Sanitária (ANVISA)

Jarbas Barbosa da Silva Jr. is a public health physician and epidemiologist, with national and international experience in public health, epidemiology applied to health services, health surveillance, prevention and control of diseases and illnesses, and management of health systems... Read More →

Carmen Maher

Acting Assistant Commissioner for Counterterrorism Policy, OCS, OC, FDA

RADM Carmen Maher, MA, BSN, RN, RAC, is a nurse officer in the U.S. Public Health Service Commissioned Corps. She is an Assistant Surgeon General and Acting Assistant Commissioner for Counterterrorism Policy and Acting Director of the Office of Counterterrorism and Emerging Threats... Read More →

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency, Netherlands

Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for... Read More →

Tuesday June 20, 2017 10:30am - 11:45am CDT
N229 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
Featured Topics Public Policy, Global Regulatory
format json
Featured Topics Public Policy,Global Regulatory
Credit Type CME, IACET, RN
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1:15pm CDT

#239B: Strategies for Managing Difficult Stakeholders

Component Type: Session

The ability to flex one’s style or approach to work with a variety of stakeholders or to find solutions to new problems continues to be a key capability for career success. Building off of the Tuesday session on leading as an extrovert, members of the PM Community will discuss and take questions on different strategies and styles they have found successful in managing difficult stakeholders on the job.

Chair

Leigh Shultz, PhD

Speakers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States

Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →

Alice Ford-Hutchinson

Director, Global Project and Alliance Management, Merck & Co., Inc.

Alice Ford-Hutchinson, PhD, PMP, is currently a Director of Global Project and Alliance Management at Merck focused in Oncology. She joined Merck in 2009 where she has provided leadership as a project manager within a variety of therapeutic areas and development stages. She previously... Read More →

Nita Ichhpurani

Senior Director, Global Clinical Development, Celerion

24 yrs of pharma experience. At Pharmacia, Nita was a Chemist and PM in Clinical Pharmacology in oncology and CNS research. At MDS, she managed Global Central lab teams and later become the Latin American Lab Manager. At Celerion, she managed drug development programs from discovery... Read More →

Leigh Shultz

Head, Commercial Trade Channels, Merck & Co., Inc.

Elizabeth Somers

Executive Director, Global Project and Alliance Management, Merck Sharp & Dohme LLC, United States

Liz is an Executive Director in Global Project and Alliance Management at Merck focusing on Discovery PM. She manages a team focused on Discovery projects including complex collaborations which leverages her experience managing complex cross functional drug development programs and... Read More →

Tuesday June 20, 2017 1:15pm - 1:45pm CDT
S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Session | 05: Regulatory, Session | 17: ContentHub, Session

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2:00pm CDT

#252: What’s New in Devices: European Medical Device Regulations and MDUFA IV

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

With the new medical device and IVD regulations in the EU, plus the renewal of MDUFA in the USA, the year 2017 is a pivotal and disruptive period for medical device and diagnostic regulations. This session explores notable developments in global device regulation

Learning Objectives

Summarize recent global device regulatory changes; Describe potential approaches for development and lifecycle management strategies to ensure future compliance.

Chair

Angela Stokes, MS

Speaker

Are You Ready for the Medical Devices Regulation? What Should Manufacturers be Considering Now
Angela Stokes, MS

The EU Medical Device Regulations: The Notified Body View
Theresa Jeary

US Perspective
LeeAnn L Chambers, MS

Moderators

Angela Stokes

Senior Director, Global Regulatory Consulting, Syneos Health

Angela Stokes has over 27 years experience in the pharmaceutical and medical device industry in a variety of Regulatory Affairs based roles, most recently as Senior Director Global Regulatory Consulting at INC Research. She is experienced in medicinal product and medical device development... Read More →

Speakers

LeeAnn Chambers

Principal Research Scientist, Global Regulatory Affairs, CMC - Devices, Eli Lilly and Company

LeeAnn Chambers has been a Regulatory Affairs professional at Eli Lilly and Company for 22 years. She assists teams in developing global registration strategies for medical devices and drug / device combination products. She has guided the preparation of device content in US IND... Read More →

Theresa Jeary

Head of Notified Body, Lloyds Register Quality Assurance (LRQA)

Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments... Read More →

Tuesday June 20, 2017 2:00pm - 3:15pm CDT
S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session

Level Intermediate
Featured Topics Global Regulatory, Devices-Combination Products
format json
Featured Topics StudentProgramming,Devices-Combination Products,Global Regulatory
Credit Type CME, IACET, RN
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2:00pm CDT

#253: Regulatory Challenges with Next Generation Sequencing

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The high interest and rapid uptake of next-generation sequencing in the clinic speaks to the promise of this technology as a valuable adjunct for optimizing therapeutic treatment, yet much of this promise remains untapped. The challenge associated with establishing a regulatory framework stems from the lack of available standards to help establish the safety and effectiveness of this technology, and from the lack of high quality, public databases with data curated from validated methods for use in clinical decision making

Learning Objectives

Explain recent efforts by regulatory bodies, academia, and regulated industry to curate data from this technology and use it for regulatory decision making.

Chair

Kim Tyrrell-Knott, JD

Speaker

What's Next for Next Gen Sequencing
Kim Tyrrell-Knott, JD

FDA Perspective
Laura Koontz, PhD

Panelist
Ingo Chakravarty

Panelist
Kelli Lynn Tanzella, PhD, MS

Moderators

Kim Tyrrell-Knott

Partner, Epstein Becker & Green, P.C.

KIM TYRRELL-KNOTT* is a Member of the Firm in the Health Care and Life Sciences practice, based in San Diego and Washington, DC, and serves on the firm's National Health Care and Life Sciences Steering Committee. She has significant experience advising investors and companies on a... Read More →

Speakers

Ingo Chakravarty

President and Chief Executive Officer, NAVICAN, An Intermountain Healthcare Company

Ingo Chakravarty, President and CEO of NAVICAN, joined Intermountain Healthcare in June 2016, spinning off NAVICAN in October 2016. He previously served in senior roles at Genmark Diagnostics, Gen-Probe, Roche Diagnostics, and Ventana Medical Systems here in the United States and... Read More →

Laura Koontz

Office of InVitro Diagnostics and Radiological Health (OIR), CDRH, FDA

Laura M. Koontz, PhD, is a member of the Personalized Medicine Staff at the Food and Drug Administration in the Center for Devices and Radiological Health. Prior to joining the FDA, she was the Director of Policy for the Ovarian Cancer National Alliance. She also was an ASHG-NHGRI... Read More →

Kelli Tanzella

Senior Director, Regulatory Affair, Clinical and Compliance Life Sciences Soluti, Thermo Fisher Scientific

Kelli Tanzella, Sr. Director Global Regulatory Affairs, Clinical, & Compliance in the Life Sciences Group at Thermo Fisher Scientific has over 25 years’ experience in the pharmaceutical and medical device industries. She is responsible for development and implementation of regulatory... Read More →

Tuesday June 20, 2017 2:00pm - 3:15pm CDT
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session

Level Intermediate
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Credit Type CME, IACET, RN
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4:00pm CDT

#291: Combination Products

Component Type: Session
Level: Intermediate

A workshop to explore the world of combination product safety. Discuss the real-world, least burdensome approach to Postmarket Safety Reporting (PMSR) for US Combination Products, in light of the final rule. Help the audience appreciate the complexity of implementing PMSR in a global organization. Participants will work in teams to work through mock case(s) of combination products approved as drug application type with a device constituent part. We will have interactive discussion about key challenges including global impact and highlight industry best practices.

Learning Objectives

Describe the basic requirements as highlighted in the final rule; Identify simple solutions to comply with the regulation.

Chair

Khaudeja Bano, MD, MS

Speakers

Khaudeja Bano

Senior Medical Director, Medical Affairs, Diagnostics, Abbott Laboratories

Khaudeja is a Physician with Masters in Clinical Research, Pharmaceutical Engineering Certification, a DBA, and a certified Project Management Professional. She is an avid Toastmaster and a certified coach. Khaudeja has 25 years of professional experience, including clinical practice... Read More →

Tuesday June 20, 2017 4:00pm - 5:00pm CDT
Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

15:Engage-Exchange, Session | 05: Regulatory, Session

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Featured Topics Devices-Combination Products
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4:00pm CDT

#277: The Reauthorization of BsUFA and its Impact on Both the Regulator and Industry

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

FDA and industry have taken lessons learned from the first four years of the biosimilar user fee agreement (BsUFA) and applied them to this first reauthorization of the program. This session will focus on changes to the program and their affect on both industry and the agency.

Learning Objectives

Discuss what's new in BsUFA II and the impact on sponsors and regulators.

Chair

Juliana Marguerite Reed, MS

Speaker

Biosimilar User Fee Act (BsUFA II) Reauthorization: Proposed Agreements
Leah Christl, PhD

Panelist
Hillel Cohen, PhD

Panelist
Kimberly Greco

Panelist
John Pakulski, RPh

Moderators

Juliana Reed

Vice President, Government Affairs, Coherus BioSciences

Extensive experience in the development of biosimilars policy around the globe. Prior to joining Coherus Biosciences, Juliana was at Hospira Inc, for over 10 years working to advance biosimilars in multiple global regions. Juliana is one of the founders of the Biosimilars Forum, the... Read More →

Speakers

Leah Christl

Associate Director for Therapeutic Biologics, TBBT, OND, CDER, FDA

Dr. Christl is the Director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs in the FDA's CDER. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for biosimilar... Read More →

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc., United States

Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas... Read More →

Kimberly Greco

Director, Research and Development Policy, Amgen Inc.

John Pakulski

Head, Regulatory Science, Biologics, Mylan Inc.

Tuesday June 20, 2017 4:00pm - 5:15pm CDT
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
Featured Topics Public Policy
format json
Featured Topics Public Policy
Credit Type CME, IACET, RN
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4:00pm CDT

#278: PMDA Town Hall

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this forum, members of PMDA’s executive staff will discuss progress made towards achieving the goals outlined in its “PMDA International Strategic Plan 2015”, as well as other initiatives currently underway. The presenters will also introduce new initiatives aiming to further PMDA’s contributions to global health, and will answer questions from the floor directly.

Learning Objectives

Identify the latest PMDA’s activities and direction on Japanese pharmaceutical regulation; Recognize the PMDA’s initiatives under the international regulatory environment.

Chair

Toshiyoshi Tominaga, PhD

Speaker

Panelist
Tatsuya Kondo

Panelist
Shinobu Uzu, MPharm

Panelist
Kazuhiko Mori, MSc

Moderators

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)

Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →

Speakers

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)

Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →

Kazuhiko Mori

Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW)

Kazuhiko Mori, MSc., is currently Councilor for Pharmaceutical Affairs, Minister’s Secretariat of the Ministry Health, Lobour and Welfare (MHLW). Mr. Mori has led many of MHLW/PMDA’s drug initiatives. He contributed to introduce new approaches to drug safety regulation including... Read More →

Shinobu Uzu

Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Mr. Shinobu Uzu is senior Executive Director, PMDA since April 2020. As Chief Safety Officer, PMDA, he was responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law until March 2018. Mr. Uzu... Read More →

Tuesday June 20, 2017 4:00pm - 5:15pm CDT
S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
Featured Topics Global Regulatory
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Featured Topics StudentProgramming,Global Regulatory
Credit Type CME, IACET, RN
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4:00pm CDT

#279: Brexit: Where Are We Now?

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Brexit will impact on the established European Regulatory environment over the next decade. It may create potential new opportunities for deeper integration of the operational processes of the EU Regulatory Network, however, and may also create potential risks for regulatory business continuity that could be harmful to patients. This session will provide an overview of the current state of play of the political process from a UK as well as an EU perspective. It will seek views from important healthcare stakeholder groups, such as industry, regulators and patients on the longer term impact as well as practical aspects that need to be considered to avoid unintended consequences for EU and UK citizens while fully respecting the political decisions. Multiple stakeholder perspectives will look at the post Brexit scenario from a UK, EU and global regulatory environment view. Key stakeholders will discuss in a panel debate the impact of the expected changes on their organization and how they will capitalize on potential opportunities or mitigate potential risks to the regulatory business.

Learning Objectives

Discuss the impacted changes on an organization; Describe how an organization can capitalize on potential opportunities or mitigate risks to their regulatory business.

Chair

Sandra L. Kweder

Speaker

Panelist
Virginia Lee Acha, PhD, MSc

Panelist
Jonathan Mogford

Panelist
Agnès Saint-Raymond, MD

Speakers

Virginia Acha

Executive Director, Research, Medical and Innovation, Association of the British Pharmaceutical Industry (ABPI)

Virginia (Ginny) has worked in private sector and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined ABPI in 2015 to lead policy for research, medical and innovation to deliver better... Read More →

Sandra Kweder

Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA, FDA, United States

Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →

Jonathan Mogford

Director of Policy, Medicines and Healthcare products Regulatory Agency (MHRA),

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency, Netherlands

Tuesday June 20, 2017 4:00pm - 5:15pm CDT
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

format json
Featured Topics Global Regulatory,Public Policy
Credit Type CME, IACET, RN
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4:45pm CDT

#293: Conversations That Matter: How do Regulatory Affairs Professionals Wish to Engage with Statisticians and Vice Versa?

Component Type: Session
Level: Basic

DIA is an important cross-functional organization for those professions like Regulatory Affairs and Statistics. Both professions are involved from early to late stage development and post-marketing. How can we help each other be more effective in our respective roles? What would both professions like to see discussed in sessions at the Annual Meeting? Statisticians turn data into knowledge. How can we be more effectively included in the Annual Meeting? Join the Statistics Community in this brainstorming discussion.

Learning Objectives

Discuss how the Regulatory Affairs and Statistics Communities might benefit from each other's community support.

Chair

Susan P. Duke, MSc

Speakers

Susan Duke

Consultant, Drug Safety Counts LLC

Susan has been active industry-wide in topics relating to quantifying patient safety since 2011 when she joined GSK's pharmacovigilance department's benefit-risk initiative. She is currently co-lead of a cross-functional initiative on safety monitoring. She has authored several publications... Read More →

Tuesday June 20, 2017 4:45pm - 5:15pm CDT
S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session | 06: Safety-PV, Session | 17: ContentHub, Session

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Featured Topics Statistics
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10:30am CDT

#331: Conversations that Matter: How do Pharmacovigilance Professionals wish to Engage with Statisticians and Vice Versa?

Component Type: Session

DIA is an important cross-functional organization for those professions like Pharmacovigilance and Statistics. Both professions are involved from early to late stage development and post-marketing. How can we help each other be more effective in our respective roles? What would both professions like to see discussed in sessions at the Annual Meeting? Statisticians turn data into knowledge. How can we be more effectively included in the Annual Meeting? Join the Statistics Community in this brainstorming discussion.

Chair

Joan Buenconsejo, PhD, MPH

Speakers

Joan Buenconsejo

Senior Director, Biostatistics, AstraZeneca

Joan Buenconsejo is Senior Director, Biostatistics supporting late stage cardiovascular, renal and metabolic therapeutic areas within biopharmaceutical R&D at AstraZeneca. Prior to AZ, she was a statistics team lead at CDER, FDA. Dr. Buenconsejo is chair of the DIA Statistics Community... Read More →

Wednesday June 21, 2017 10:30am - 11:00am CDT
S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

06: Safety-PV, Session | 05: Regulatory, Session | 17: ContentHub, Session

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Featured Topics Statistics
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10:30am CDT

#317: Evolution of Novel Registration Endpoints as Diseases Become Chronic

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-17-530-L04-P; CME 1.25; IACET 1.25; RN 1.25

Recent advances in medicine have rendered once-acute diseases into chronic burdens, but serious unmet medical needs remain for these patients. Addressing these unmet medical needs with novel therapies requires new and flexible endpoints acceptable to global regulators. This session tackles possible approaches to address the endpoint gap using the immunooncology development paradigm as a case study.

Learning Objectives

Describe endpoint gaps for long term diseases; Evaluate alternative endpoint approaches using immuno-oncology as a case example.

Chair

Irene Nunes, PhD

Speaker

Evolution of Novel Efficacy Registration Endpoints to Quantitate Improved Long Term Survial Effects of New Drugs
Irene Nunes, PhD

Challenges in Evaluating Immuno-Oncology Products
Rajeshwari Sridhara, PhD

Endpoint Minimal Residual Disease Used for Novel Multiple Myeloma Therapies
C. Ola Landgren, MD, PhD

Regulatory Considerations for Novel Endpoints in Immuno-Oncology
Marc Theoret

Moderators

Irene Nunes

Executive Director, Global Regulatory Affairs, Daiichi Sankyo Co., Ltd.

Irene Nunes is a 13yr physician scientist with experience in drug development and global regulatory affairs. She has been a project lead for consortia projects for the last 10 yrs and actively working on the clinical qualification of novel kidney safety biomarkers for drug development... Read More →

Speakers

C. Ola Landgren

Professor of Medicine and Chief of Myeloma Service, Memorial Sloan Kettering Cancer Center

Dr Ola Landgren has designed studies to define biological mechanisms of transformation from myeloma precursor disease to myeloma. He has developed (1) early interventional clinical trials for patients with high-risk smoldering myeloma to delay/prevent transformation; (2) modern intervention... Read More →

Rajeshwari Sridhara

Senior Biostatistician Consultant, Oncology Center of Excellence, FDA, FDA, United States

Rajeshwari Sridhara, Ph.D. is the Division Director of Division of Biometrics V, Office of Biostatistics which supports Office of Hematology Oncology Products in the Oncology Center of Excellence and Center for Drug Evaluation and Research. As a leader in the field, she routinely... Read More →

Marc Theoret

Associate Director of Immunotherapeutics, OHOP, OND, CDER, FDA

Dr. Theoret is a medical oncologist and the Associate Director of Immunotherapeutics in the Office of Hematology and Oncology Products, CDER, FDA. In his role as Associate Director, Dr. Theoret is leading initiatives in immuno-oncology product development—regulatory, scientific... Read More →

Wednesday June 21, 2017 10:30am - 11:45am CDT
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session

Level Intermediate
Featured Topics Clinical Operations, Academic Clinical Researcher, Patient Centric
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Featured Topics Clinical Operations,Academic Clinical Researcher,Patient Centric
Credit Type ACPE, CME, IACET, RN
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1:00pm CDT

DIA Regulatory Affairs Community, Regulatory Intelligence WG Round Table Discussion: The Evolving Role of Using Artificial Intelligence to Deliver Actionable Intelligence

Component Type: Session

Join DIA RA Community, Regulatory Intelligence Working Group for a round table discussion tied to session #215 The Evolving Role of Using Artificial Intelligence to Deliver Actionable Intelligence (Tuesday, June 20th)

Chair

Emily Huddle

Speaker

DIA Regulatory Affairs Community, Regulatory Intelligence WG Round Table Discussion: The Evolving Role of Using Artificial Intelligence to Deliver Actionable Intelligence
Elizabeth Rosenkrands-Lange, MPH, MS

Speakers

Emily Huddle

Regulatory Intelligence Manager, Gilead Sciences, Inc.

Emily Huddle has been working in the pharmaceutical industry for over 15 years, including nine years working in Regulatory Affairs and five years in Regulatory Intelligence. Primary responsibilities in her current role as a Regulatory Intelligence Executive within GlaxoSmithKline's... Read More →

Elizabeth Rosenkrands-Lange

Senior Manager, Regulatory Policy and Intelligence, LEO Pharma

Wednesday June 21, 2017 1:00pm - 1:45pm CDT
Community Corner McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

19: DIACommunities, Session | 05: Regulatory, Session

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2:00pm CDT

#343: Expanded Access and Compassionate Use

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Early access to medicines is increasingly sought by patients, physicians and legislators. Regulators and industry must work together to optimize patient access ethically and in a medically appropriate way while remaining focused on registration efforts. How to find the right balance? What are some case examples?

Learning Objectives

Discuss case studies of patient need and access approaches prior to regulatory approval.

Chair

Ramana Sonty, PhD

Speaker

CDER Experience: Expanded Access in Drug Development and Review
Kevin Bugin, MS, RAC

Making Compassion Work: Challenges and Next Steps
Elena Gerasimov, MA, MPH

Independent Evaluation of Compassionate Use Requests to Benefit Patients: The NYU J&J CompAC
Ramana Sonty, PhD

Navigating the Regulatory Pathways of Early Access to Medicines in the EU
Grant Strachan, LLM

Moderators

Ramana Sonty

Director, Global Medical Organization, Johnson & Johnson, United States

Dr. Sonty is a Strategy Leader in the Global Medical Organization of Janssen R&D. He is currently leading efforts to transform the Safety Organization, including implementing advances in Data Sciences, Visualization & Analytics and Automation. Previously he helped launch Janssen’s... Read More →

Speakers

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States

Dr. Bugin is an experienced pharmaceutical professional who has made significant contributions to drug development and regulatory science. He currently serves as the Deputy Director of Operations ,in this role, he plays a key leadership role in the evaluation of new drugs and ensures... Read More →

Elena Gerasimov

Director, Compassionate Use Navigator Program, Kids V Cancer

Elena is Director of Programs at Kids v Cancer, a nonprofit dedicated to changing the landscape of pediatric research. She built and directs the Compassionate Use Navigator program, which assists physicians and families applying for investigational drugs. She has experience working... Read More →

Grant Strachan

Senior Associate, Regulatory, Bristows LLP

Grant Strachan is a Senior Associate in the IP Regulatory Practice at Bristows LLP. Grant advises on both contentious and non-contentious EU and UK regulatory law in the healthcare and life sciences sector. This includes: advising on clinical trials; transparency and clinical data... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm CDT
N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
Featured Topics Rare Disease, Patient Centric
format json
Featured Topics Patient Centric ,Rare Disease
Credit Type CME, IACET, RN
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2:00pm CDT

#344: Minding the Gaps: Using Totality of Evidence in the Clinical and CMC Contexts to Support Regulatory Approval

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Regulatory approval dossiers often lack full evidence in areas such as clinical or CMC. Sponsors and regulators can sometimes accommodate gaps in data by utilizing a totality of evidence approach. Examples of this include the use of totality of evidence in CMC packages for botanicals and clinical packages for accelerated or conditional approval of new active substances in general. This session will dive into the concept of totality of evidence and explore recent FDA and EMA approvals that relied on totality of evidence. Attendees will learn how to distinguish between valid and questionable uses of totality of evidence and how to apply totality of evidence in their development programs.

Learning Objectives

Identify how to use totality of evidence to support regulatory approval; Describe how to leverage regulatory flexibility in small or limited clinical programs; Develop strategies to overcome limitations in CMC packages, especially for botanical drug development.

Chair

Alexander Varond, JD

Speaker

Short of Perfect - Approval With Data That's Less Than Optimal
Alexander Varond, JD

Clinical Evidence to Support Marketing Authorizations: Focus on Regulatory Approvals Based on a Single Pivotal Trial
Anne Vinther Morant, PhD, MSc

FDA’s Totality-of-Evidence Approach in Botanical New Drug Approval
Charles G. Wu, PhD

Moderators

Alexander Varond

Associate, Goodwin Procter LLP

Alexander J. Varond works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity... Read More →

Speakers

Anne Morant

Senior Specialist, Regulatory Science & Advocacy, H. Lundbeck A/S

Anne Vinther Morant is a Senior Specialist in Regulatory Science & Advocacy at H. Lundbeck A/S. Since 2008 she has worked in various functions within regulatory strategy and regulatory science with focus on development of medicines to treat psychiatric and neurologic diseases. Anne... Read More →

Charles Wu

Expert Pharmacologist, OPQ, CDER, FDA

Dr. Charles Wu is an Expert Pharmacologist at Center for Drug Research and Evaluation of the FDA. He was trained in clinical medicine including the Traditional Chinese Medicine and earned his Ph.D. from University of Amsterdam. He has been working at the FDA since 2001 after a fellowship... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm CDT
S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session

Level Intermediate
Featured Topics Clinical Operations, Rare Disease
format json
Featured Topics Rare Disease,Clinical Operations
Credit Type CME, IACET, RN
Tags Session

2:00pm CDT

#345: Global Perspective on ICH: Part 1 of 2

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will provide an overview of the ICH association and offer insight into strategic, long-term views on advancing global convergence of regulatory science through ICH, including important enablers such as stakeholder partnerships and greater connection to other harmonization initiatives. A panel of experts will discuss the benefits of ICH and global regulatory harmonization, including views on key strategic topics that will enhance simultaneous global drug development.

Learning Objectives

Describe the structure of the ICH association, the process for developing a harmonized guideline, and the purpose for the recent reforms; Discuss ICH’s strategic approach in the selection of topics for guidance development; Explain the current state and the future trajectory of ICH; Discuss the value of ICH to regulatory authorities; Identify some of the areas of current ICH guideline development.

Chair

Amanda Marie Roache

Speaker

Regulatory Perspective on ICH
Toshiyoshi Tominaga, PhD

Recap of Recent ICH Meeting
Cathy A. Parker

Panelist
Theresa M. Mullin, PhD

Panelist
Gabriela Zenhausern, DrSc

Speakers

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States

Cathy Parker

Director General, Biologics & Genetic Therapies Directorate HPFB, Health Canada

Catherine Parker Director of the Office of Policy and International Collaboration within the Biologics and Genetic Therapies Directorate of Health CanadaHer Office has overall responsibility for all policy and regulatory development respecting biologic drugs. She played a key role... Read More →

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States

Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)

Gabriela Zenhausern

Technical Officer, Regulatory Networks and Harmonization Team, World Health Organization (WHO)

Gabriela Zenhausern has worked for Swissmedic before joining WHO in December 2015. As a technical officer in the Regulatory Systems Strengthening Team (RSS), she provides support to various regulatory harmonization initiatives and regulatory networks in different WHO regions. Gabriela... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm CDT
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
Featured Topics Statistics, Global Regulatory, Academic Clinical Researcher
format json
Featured Topics StudentProgramming,Statistics,Global Regulatory,Academic Clinical Researcher
Credit Type CME, IACET, RN
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2:00pm CDT

#346: Understanding the New Common Rule and Its Impact to Industry

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-570-L04-P; CME 1.25; IACET 1.25; RN 1.25

On the final days of the outgoing administration, the Office of Human Subject Protections posted sweeping changes to federal regulations regarding human subjects research. The first substantive changes to human subjects research regulation in nearly 30 years! While the changes are focused at federal funding agencies, the implications for industry are enormous. New consenting requirements, new IRB requirements, requirements to post final consent forms to clinical trials.gov and a host of other changes will impact research operations, protocol design, and clinical trial implementation across the industry.

This late breaking session will explore all changes and give practical tips to sponsors on how to address the change.

Learning Objectives

Discuss the basics of the new requirements; Explain the history and rationale for the changes; Identify how to activate programs and systems to prepare for the new requirements.

Chair

James Riddle, MS

Speaker

Perspective From the Office of Human Subject Protection
Laura Odwazny

Common Rule Changes: Impact on Industry
James Riddle, MS

Speakers

Laura Odwazny

Senior Attorney, Office of Human Subject Protection, Office of General Counsel, Department of Health and Human Services

Laura M. Odwazny is a Senior Attorney with the Office of the General Counsel, U.S. Department of Health and Human Services. Throughout her 17 years at HHS, Ms. Odwazny's primary client has been the Office for Human Research Protections, which interprets and enforces the HHS protection... Read More →

James Riddle

Vice President, Strategic Consulting, Advarra

James Riddle is the VP of Strategic Consulting for Advarra, where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Advarra Consulting worldwide. Mr. Riddle is also a faculty member, mentor, and regular... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm CDT
N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

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Featured Topics Academic Clinical Researcher,Patient Centric
Credit Type ACPE, CME, IACET, RN
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4:00pm CDT

#373: FDA–Health Canada Regulatory Cooperation Council Town Hall

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The Regulatory Cooperation Council (RCC) was created in 2011 to develop smarter and more efficient and effective approaches to regulatory cooperation. FDA and Health Canada will highlight their work under RCC phase 2 and request stakeholder input on their current initiatives.

Learning Objectives

Discuss FDA and Health Canada Regulatory Cooperation Council (RCC) priority areas over the next two years; Identify areas for stakeholders to contribute to the RCC process.

Chair

Sema D. Hashemi, MSc

Speaker

Panelist
Isabel Romero

Speakers

Sema Hashemi

Director, Office of Regional and Country Affairs, OIP, OC, FDA

Ms. Hashemi has made significant contributions to FDA, having worked for the Agency since 1998 and serving in OIP for over 15 years in a variety of positions including Acting Director, Asia-Pacific Office; Acting Deputy Country Director China Office in Beijing; Deputy Director, ORCA... Read More →

Isabel Romero

Director, International Affairs, Health Canada

Wednesday June 21, 2017 4:00pm - 5:00pm CDT
S401d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
Featured Topics Global Regulatory
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Featured Topics StudentProgramming,Global Regulatory
Credit Type CME, IACET, RN
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4:00pm CDT

#370: Lessons Learned from the Sarepta Exondys 51 Approval

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-531-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA’s approval amidst controversy of Sarepta’s Duchenne muscular dystrophy drug Exondys 51 (eteplirsen) was unprecedented in terms of the level of flexibility used to support accelerated approval in a rare disease. This session explores the unique conditions surrounding the drug’s patient-focused drug development program and its approval.

Learning Objectives

Describe circumstances surrounding the development and ultimate approval of eteplirsen; Identify how to apply lessons learned to other drug development efforts.

Chair

Shamim Ruff, MSc

Speaker

A Challenging Path: Bridging Patient Needs With Regulatory Approval Requirements
Shamim Ruff, MSc

The Role of the Patient Perspective in the Approval of Exondys 51
Christine McSherry, RN

The Evolving Role of Orphan Drug and Subpart H Flexibility in Drug Approval
Alexander Varond, JD

Moderators

Shamim Ruff

Senior Vice President of Regulatory Affairs and Quality, Sarepta Therapeutics

Speakers

Christine McSherry

Executive Director, Jett Foundation

Christine McSherry is the executive director of Jett Foundation, a non-profit dedicated to Duchenne muscular dystrophy, and the co-founder of Casimir Trials, a CRO that designs patient, caregiver, and observer reported outcomes that support regulatory approval and reimbursement. Christine... Read More →

Alexander Varond

Associate, Goodwin Procter LLP

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
Featured Topics Patient Centric, Public Policy, Rare Disease
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Featured Topics Patient Centric ,Rare Disease,Public Policy
Credit Type ACPE, CME, IACET, RN
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4:00pm CDT

#371: Global and Regional Collaboration Initiatives: Challenges, Opportunities, and Case Studies

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Several global and regional collaboration initiatives are in place in order to foster access to medicines, specifically for patients in developing countries. The main objectives of these initiatives are to accelerate approval processes based on regulatory collaboration and reliance. As an example, supported by the World Health Organisation (WHO), National Medicines Regulatory Authorities (NMRAs) can inform their own assessment report process by drawing on the assessment performed by a reference authority, so called Stringent Regulatory Authority (SRA). Based on selected case studies, this session will examine collaboration initiatives and review the opportunities and challenges from authority and industry perspective.

Learning Objectives

Discuss the complexity of regulatory convergence; Identify the progress being made through case studies.

Chair

Joseph C. Scheeren, PharmD

Speaker

Regulatory Collaboration Initiatives in Order to Accelerate Approval Process in Developing Countries
Petra Doerr, PharmD, PhD, RPh

Collaborative Registration Procedure: A Tool to Accelerate Regulatory Approvals - Case Studies from Africa
Mercè Caturla Goñi

A Novel Tool to Support Optimized Regulatory Strategies for Emerging Markets: A Case Study
Rajneesh Taneja, PhD

Moderators

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer

Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →

Speakers

Petra Doerr

Deputy Executive Director, Swissmedic

Since January 2014 Head of Communication and Networking and Deputy Executive Director at Swissmedic, Swiss Agency for Therapeutic Products. Oversees the international cooperation with other agencies and international organisations. Member of the ICH Management Committee & Vice-chair... Read More →

Mercè Caturla Goñi

Global Access Regulatory Leader, Regulatory Policy (Africa and WHO), Janssen Pharmaceutical Companies of Johnson & Johnson

Mercè Caturla is the Global Access and Regulatory Policy (Africa and WHO) Lead at Janssen. She is primarily responsible for leading and overseeing coherent and unified regulatory strategies to make medicines accessible in resource limited settings, Africa in particular. She participates... Read More →

Rajneesh Taneja

Senior Director, Pharmaceutical Product Development, TB Alliance

Raj is the Sr. Director for Pharmaceutical Product Development at TB Alliance, a non-profit organization developing novel TB treatments. His responsibilities include developing drug products, formulating combination products, and designing regulatory and market access strategies... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session

Level Intermediate
Featured Topics Global Regulatory
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Featured Topics Global Regulatory
Credit Type CME, IACET, RN
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4:00pm CDT

#372: The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

GDUFA II creates a new program to support development of complex generic products including development meetings, pre-filing meetings and mid-cycle communications. This session will look at the details of the draft commitment letter and the future environment for complex generics.

Learning Objectives

Discuss what’s new in GDUFA II and the impact on sponsors and regulators.

Chair

Linda F. Bowen

Speaker

Complex Generics: How Pre-ANDA Interactions with the Office of Generic Drugs Work
Robert A. Lionberger, PhD

GDUFA II and Regulatory Science Initiatives: Pre-ANDA Program for Complex Generic Drugs
Scott D Tomsky, MS

Industry Perspective
Keith Webber, PhD

Moderators

Linda Bowen

Senior Director, Global Regulatory Science and Policy, Sanofi

Speakers

Robert Lionberger

Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA

Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants... Read More →

Scott Tomsky

Vice President, Regulatory Affairs, Generics, North America, Teva Pharmaceuticals

Scott D. Tomsky is Vice President, Regulatory Affairs, Generics, North America at Teva. He has been actively involved in the pharmaceutical industry for more than 20 years. Scott has held various positions in R&D, Quality Control and Regulatory Affairs at Johnson and Johnson, Ranbaxy... Read More →

Keith Webber

Sr. Dir. Rx Regulatory Affairs, Perrigo Company plc

Keith Webber is Senior Director of Rx Regulatory Affairs at Perrigo Company. Prior to joining industry, he served at the US FDA in both the CDER and CBER in a variety of roles including Director of the Office of Pharmaceutical Science, Director of the Office of Generic Drugs, Director... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
N229 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session

Level Intermediate
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Credit Type CME, IACET, RN
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4:00pm CDT

#374: Global Perspective on ICH: Part 2 of 2

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-532-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will provide an overview of the ICH association and offer insight into strategic, long-term views on advancing global convergence of regulatory science through ICH, including important enablers such as stakeholder partnerships and greater connection to other harmonization initiatives. A panel of experts will discuss the benefits of ICH and global regulatory harmonization, including views on key strategic topics that will enhance simultaneous global drug development.

Learning Objectives

Discuss what the ICH reforms mean for global development as ICH moves toward being a truly global platform for international harmonization; Describe ICH's connection to other global harmonization/convergence forums; Identify the value and benefits of global regulatory harmonization and the ICH; Discuss opportunities to advance regulatory science through ICH.

Chair

Patrick K Brady, PharmD

Speaker

Fostering Simultaneous Global Development via Regulatory Harmonization and ICH Reforms
Camille Jackson

Partnership and Global Connectivity After ICH's Reform: New Opportunities for Global Regulatory Harmonization and Advancing Regulatory Science
Jerry Stewart, JD, MS, RPh

Panelist
Lawrence Eugene Liberti, MS, RPh, RAC

Moderators

Patrick Brady

Vice President, Regulatory Affairs Head, Regulatory Policy and Intelligence, Bayer AG

Speakers

Camille Jackson

Associate Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)

Camille Jackson is currently Associate Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she manages PhRMA’s international regulatory policy initiatives including engagement in the International Council for Harmonization (ICH) and the APEC Regulatory Harmonization... Read More →

Lawrence Liberti

Head, Regulatory Collaborations, Centre for Innovation in Regulatory Science (CIRS)

Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →

Jerry Stewart

Deputy Vice President, Scientific and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)

Mr. Jerry Stewart, JD, MS, RPh, is Deputy Vice President at the Pharmaceutical Research and Manufacturers of America (PhRMA), located in Washington, DC, USA. He is responsible for international regulatory science policy and advocacy, and the global pharmaceutical manufacturing and... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Forum

Level Intermediate
Featured Topics Academic Clinical Researcher, Clinical Operations, Global Regulatory, Statistics
format json
Featured Topics StudentProgramming,Global Regulatory,Statistics,Clinical Operations,Academic Clinical Researcher
Credit Type ACPE, CME, IACET, RN
Tags Forum