DIA 2017 Annual Meeting: Full Schedule

11:00am CDT

#127: The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India

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

This panel will use a case study format and present the risk-based approach used to select sites for inspection and discuss the role of FDA’s international offices in facilitating inspections and engaging with regulatory counterparts in country. The forum will review violations that called into question the accuracy of data, and discuss the impact to drug applications.

Learning Objectives

Identify the risk-based approach for selecting firms for inspection and define the role of FDA’s international offices in inspections; Describe inspectional findings of a bioequivalence/bioanalytical firm in India that demonstrated significant violations impacting data quality; Discuss the process for considering regulatory impact of inspectional findings and implementing follow up actions.

Chair

Leslie Ball, MD

Speaker

Panelist
Sean Y. Kassim, PhD

Panelist
Mathew T. Thomas, MD

Panelist
Arindam Dasgupta, PhD

Speakers

Leslie Ball

Assistant Commissioner and Deputy Director, OIP, OC, FDA

Since September 2012, she has served as Assistant Commissioner and Deputy Director of the FDA’s Office of International Programs (OIP). OIP leads FDA’s international activities and oversees the operation of FDA’s eleven regional and country offices. Prior to this position, she... Read More →

Arindam Dasgupta

Deputy Director, Division of New Drug Bioequivalence, OSIS, OTS, CDER, FDA

Arindam received his M.S. in Biophysics and Molecular Biology from the University of Calcutta (1994) and Ph.D in Molecular Biology from Jadavpur University, Kolkata. After finishing his Ph.D., he was a postdoctoral researcher at UVA and NIH (1999-2008). He joined CDER as a Pharmacologist... Read More →

Sean Kassim

Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA

Sean serves as the Director of the Office of Study Integrity and Surveillance, CDER/FDA. He oversees the bioavailability/bioequivalence (BA/BE) and GLP inspection programs that inspect and review conduct of regulated pharmaceutical premarket bioanalytical and non-clinical researc... Read More →

Mathew Thomas

Country Director, India Office, Office of International Programs, OC, FDA

Dr. Mathew T. Thomas serves as the Acting Director for the FDA India Office from February 23, 2015. Prior to this posting Mathew was the Director of the Division of Enforcement and Postmarket Safety (DEPS), in CDER’s Office of Scientific Investigations (OSI) within the Office of... Read More →

Monday June 19, 2017 11:00am - 12:15pm CDT
S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

11: Quality, Forum

Level Intermediate
Featured Topics Global Regulatory
format json
Featured Topics Global Regulatory
Credit Type CME, IACET, RN
Tags Forum

11:00am CDT

#128: Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment

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

Two and one half years after stand-up, FDA’s Office of Pharmaceutical Quality is firmly established in it’s primary mission of assuring the quality and availability of safe and effective medicines to the public. The progression in organizational maturation allows a growing focus on innovative approaches to regulatory review and inspection in the agency’s ongoing efforts at continuous improvement and utilization of emerging technologies. This session will outline ongoing initiatives underway in OPQ and will provide the audience with access to selected OPQ senior leadership.

Learning Objectives

Describe initiatives and implementation strategies related to the Product Quality Benefit/Risk Framework; Explain OPQ’s current view on science and risk-based policies and standards related to drug product quality; Discuss how FDA facilitates the adoption of emerging technology into pharmaceutical manufacturing.

Chair

Patrick Ricucci, PMP

Speaker

A Regulatory Perspective on Science and Risk-Based Policies and Standards Related to Product Quality
Laurie Graham

Panelist
Wendy Wilson-Lee, PhD

OPQ's Innovative Approaches For Facilitating the Adoption of Emerging Technology
Lucinda F. Buhse, PhD

Speakers

Lucinda Buhse

Director, Office of Testing, OPQ, CDER, FDA

Dr. Buhse joined OTR in 2001 as Deputy Director of Division of Pharmaceutical Analysis. She was promoted to Division Director in 2004 and has been Director of Office of Testing and Research since 2013. Dr. Buhse received a B.A. in Chemistry from Grinnell College and a Ph.D. in Physical... Read More →

Laurie Graham

Director, DIPAP, OPPQ, OPQ, CDER, FDA, United States

Laurie Graham is currently the Director of the Division of Internal Policies and Programs (DIPAP) in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) at the Center for Drugs Evaluation and Research (CDER). DIPAP is responsible for... Read More →

Patrick Ricucci

Associate Director of Regulatory Affairs (Acting), ONDP, OPQ, CDER, FDA

Patrick is the acting Associate Director of Regulatory Affairs in the Office of New Drug Products (ONDP) within FDA’s Office of Pharmaceutical Quality. He’s also a certified Project Management Professional (PMP). Patrick is intricately involved in ONDP efforts such as strategic... Read More →

Wendy Wilson-Lee

Acting Branch Chief, Office of New Drug Products, OPQ, CDER, FDA

Wendy is an acting Branch Chief in the Office of New Drug Products, bringing 10 years of review experience to the position. She has a B.S. in Chemical Engineering as well as a B.S. in Chemistry from North Carolina A&T State University. She earned her Ph.D. in Pharmaceutical Science... Read More →

Monday June 19, 2017 11:00am - 12:15pm CDT
N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

11: Quality, Forum

format json
Credit Type CME, IACET, RN
Tags Forum

10:30am CDT

#329: Measuring and Advancing the Clinical Quality Management System

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

This session will discuss various options for evaluating the maturity (i.e. effectiveness and efficiency) of a clinical quality management system. Methods for determining the course of actions and priorities will also be reviewed.

Learning Objectives

Discuss options for evaluating the maturity of a clinical quality managament system.

Chair

Robert Studt

Speaker

Management Review of the Clinical Quality System
Robert Studt

Overview of the ACQMS Tool
Mary Fleres

CRO Perspective: Working With Multiple Clinical QMS Scenarios
Elizabeth Troll, MS

Speakers

Mary Fleres

Senior Manager, Quality Management Services, Allergan

Mary is Senior Manager, Quality Management Systems, for Allergan. She is responsible for inspection readiness and management activities as well as managing procedural documents and training for Global R&D Quality. Prior to joining Allergan, she held positions of increasing responsibility... Read More →

Robert Studt

Head of Quality Analytics, BioResearch Quality and Compliance, Janssen, United States

Rob is currently the head of Quality Analytics in Johnson & Johnson's BioResearch Quality & Compliance. He began his career as a drug discovery chemist, and has worked in leadership roles in Drug Discovery, R&D IT, and Quality & Compliance. Current interests are in applications of... Read More →

Elizabeth Troll

Consultant, Consultant

Elizabeth (Liz) Troll brings 30+ years of Quality Management leadership in all aspects of systems design for GCP, GLP and GMP compliance on a world-wide level, As an Executive level leader focused on the design and implementation of Compliance and Quality Assurance programs on a global... Read More →

Wednesday June 21, 2017 10:30am - 11:45am CDT
S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

11: Quality, Forum

format json
Credit Type CME, IACET, RN
Tags Forum