DIA 2017 Annual Meeting

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  

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.
  
  

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
  

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

Payers play an important role in both national and global health care systems: their decision-making signals to manufacturers their likelihood to support the R&D required for innovative, new medicines. Only a small number of innovative medicines are approved annually. The large proportion of new drug candidates fail during the development, and the average R&D cost per approved new molecular entity is increasing. Providers and payers can be thought of as agents acting on behalf of patients and their covered beneficiaries. Payers are critical in expressing the willingness of health care systems to provide funds to support innovation. Manufacturers must understand, monitor, and anticipate the evolving payer environment to increase the likelihood of regulatory and commercial success for new products. Key tools such as pharmacoeconomic evaluation of cost-effectiveness and budget impact, as well as important processes such as health technology assessment are used in many developed countries. Understanding their varying role in different jurisdictions is critical for pricing and market access negotiations. This short course, which is hosted with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), will introduce participants to the basic economics of drug development, pricing, contracting, and market access. It will address commonly used economic concepts, such as demand, supply, willingness to pay, monopoly, intellectual property, and value. Practical observations will be made on the similarities and differences in how health care systems approach these pricing and access practices and decisions, with an emphasis on the implications for stakeholder incentives. Examples will be used to illustrate key concepts in both routine and special cases.


Who should attend?

This short course is designed for industry professionals and academics with an interest to learn more about the economic perspective on drug development, incentives for innovation, and how different countries grapple with these difficult health sector resource allocation decisions.

Learning Objectives

Explain what makes innovative medicines unique economic inputs into population health including how the patent system relates to the financing of global R&D

Discuss in what way prices for innovative medicines are established, how this differs by system, as well as the evolving impact of pharmacoeconomics and health technology assessment

Describe how the complex global network of public and private payers judge the value of innovative medicines

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

Learn what regulators are looking for from sponsors and CROs as they initially assess their vendors and audit investigator sites for compliance and oversee them for compliance and quality throughout the clinical trial. As clinical trials become more complex involving additional data and vendors, why is it that companies keep using the traditional audit plan? As technology has provided the transparency and tools needed for trending, review and analytics, why is it that companies have yet to evolve to utilize them? Discuss various risk-based methodologies for audit programs and how logistical issues such as governmental travel advisories, environmental travel restrictions, resource issues (such as timing, budget) and availability of qualified individuals (auditors) may necessitate innovation to accomplish audit goals. Discuss case studies to assess risk in various remote auditing options which may provide a snapshot of compliance when travel may not be possible at that time and may assist in training auditors or providing subject matter expertise as needed from statisticians, IT professionals, etc. Learn methods for selecting what to audit and to what extent the auditing should be performed based on factors which may contribute to, or increase/decrease risk to subject safety and rights or data quality/integrity. Produce an audit plan that can be adapted for use to qualify (initial and re-qualification) and audit vendors (CROs, pharmacovigilance, eCOA vendors, etc.), study sites, and internal processes (when the department is off-site). Use the plan for auditing study site data, trial master files (TMF), databases, imaging data, etc.

Who should attend?

This short course is designed for:

• Quality personnel from sponsor companies, CROs, and vendors
• Data Managers, Clinical Operations, CRAs, Clinical Scientists, Medical Monitors and other project leaders with ideas on how and what critical to quality data should be presented to auditors
• Representatives/ consultants of companies that provide auditing services
  
  Learning Objectives
  
  At the conclusion of this course, participants should be able to:
  • Determine which data is critical to quality using risk-based methodologies
  • Explore novel methods to access documents and data.
  • Develop more comprehensive and cross functional audit plans for oversight activities of vendors and CROs
  • New methods to host/ conduct a qualification, vendor, study site, or other GCP audits
    
    

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  

Component Type: Tutorial
CE: CME 3.25; PDU 3.25 PMI 2166-000197; RN 3.25

The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This short course addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.

Who should attend?

This short course is designed for individuals who must manage group activities on a permanent or project basis, for those who must work on teams but are not in charge of teams and want to learn how to exert influence on group behavior. This course will also benefit individuals to whom project managers report.

Learning Objectives

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

• Identify the different types of work group structures and be able to predict the quality of work the group will produce
• Identify ways to correct dysfunctional group dynamics
• Create and maintain cooperation among team members, including cross-functional teams
  

Component Type: Tutorial
CE: CME 6.50; IACET 6.50; RN 6.50

The objective of this short course is to provide a platform to address frequently asked questions and recent updates/developments in relation to the EU guidelines on good pharmacovigilance practices taking into account their global application and focusing on the following interest areas:

Overview of the latest developments in the area of pharmacovigilance in the EU including related IT systems

Management and reporting of adverse reactions and signal management

Updates of GVP Module VI •The new EU E2B(R3) ICSR implementation guide

New process for marketing authorization holders regarding the monitoring of medical literature and entry of relevant information into the EudraVigilance database by the EMA

Updates to the EudraVigilance Access Polic

Who should attend?

This short course is designed for professionals who work in the following areas: clinical safety and pharmacovigilance, regulatory affairs, risk management, quality and compliance.

Learning Objectives

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

• Describe recent developments on EU Good Pharmacovigilance Practices guidance
• Examine principles for new literature monitoring and the revised EudraVigilance Access Policy
• Discuss FAQs in signal management
• Identify important aspects in preparing risk management plans and conducting - is something missing here?
• Describe key principles for pharmacovigilance audits and inspections
  
  

Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-17-509-L04-P; CME 6.50; IACET 6.50; RN 6.50

This short course is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or CRO). The instructors, with the use of a case study presentation, will provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented.

Who should attend?

This short course is designed for regulatory affairs professionals, drug safety specialists, biostatisticians, medical writers, clinical researchers, project managers, and investigators.

Learning Objectives

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

• Discuss how to utilize guidelines and regulatory requirements for clinical trials
• Describe ways to contribute to safety analysis plans
• Discuss the statistical safety analysis process and pitfalls that could occur
• Identify impact of benefit-risk assessment in safety data
  
  

Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-17-505-L04-P; CME 6.50; IACET 6.50; RN 6.50

This short course will introduce basic statistical concepts that are fundamental to clinical research. It is designed for individuals with some exposure to statistics (either through course work or on-the-job experience) that is equivalent to an introductory statistics course. While a few formulae are included for individuals who are interested in computational details, the overall emphasis of the course will be on the application of statistical concepts to clinical investigation.

Who should attend?

This course is designed for professionals in the pharmaceutical industry involved in clinical research, medical affairs, medical writing, and other disciplines, who need to be familiar with statistical concepts.

Learning Objectives

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

• Discuss basic statistical concepts such as variability, confidence intervals, hypothesis testing, and p-values
• Compare various study designs including techniques to avoid bias
• Use statistical terminology with ease
• Distinguish information needed for determining sample size
  
  

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-17-504-L04-P; CME 3.25; IACET 3.25; RN 3.25

Risk evaluation and mitigation strategies (REMS) vary from simple to complex. Particularly for the complex Elements to Assure Safe Use (ETASU) REMS, data in the form of a REMS assessment report may greatly challenge team members as many may be new to the process. Creation of a REMS assessment report requires a high-functioning, coordinated and cooperative team (whether done all in-house or including vendors). During this short course, participants will hear about relevant FDA regulations and guidances, recent status of REMS, and experiences in leading teams to successfully create REMS assessment reports. During hands-on activities, participants will receive case studies, discuss and role play as key functional areas — data management, project writing, medical writing, pharmacovigilance, drug safety, epidemiology, and regulatory affairs, with an emphasis on providing a timely, high-quality deliverable. Time will be spent on refinement of the project plan, development of the table of contents, and how to coordinate disparate sections such as knowledge survey reports and adherence metrics. Discussion will also focus on topics such as the content of the REMS assessment as dictated by the REMS and REMS approval letter, determination of data cut-off dates, working with vendors, what to include in the report regarding survey design issues such as comprehension testing, special concerns for shared REMS, and FDA input and timing.

Who should attend?

This course is designed for professionals involved in clinical safety and pharmacovigilance.

Learning Objectives

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

• Describe the key milestones needed to create a REMS assessment report
• Identify who and how to engage in the multidisciplinary team required to create the report
• Discuss the type of sections included in various types of REMS assessment reports
  
  

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

This short course will focus on how digital health technologies are being developed and regulated in the pharmaceutical/combination products space. Although many digital health technologies follow a fairly straightforward regulatory path as devices, those that interact with drug products often encounter more regulatory uncertainty. FDA’s policy on how mobile medical apps, clinical decision support software, and wearables can be combined with pharmaceutical use is still in development, so it is often difficult to navigate the regulatory path to market for these products. This course will look at currently available FDA guidances and what they mean for digital health products that combine both a drug and device. Participants will explore how to work with FDA when developing digital health technologies that may veer outside of established regulatory pathways, and a series of case studies will examine how innovators have addressed development and regulatory hurdles.

Learning Objectives

Describe how digital health technologies are being regulated by FDA through a discussion of current FDA guidances and their effect on the development and approval of digital health products, some of which combine both a drug and device; Identify how to work with FDA when developing digital health technologies via established regulatory pathways and what to do when those technologies veer outside of established regulatory pathways.

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)
    
    

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
  
  

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

The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This short course, will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.

Who should attend?

This short course is designed for professionals involved with clinical and data operations.

Learning Objectives

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

• Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology
• Discuss the use of key tools in the RBM process
• Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology
  
  

Component Type: Tutorial
CE: CME 3.25; RN 3.25

This course is designed to help you understand what culture, bureaucracy and innovation really are, and the impact they can have on actual business results — in concrete, clear terms. This requires stripping away the vagueness and assumptions that so commonly surround these topics. The discussion will include three primary components:

1. Understanding and influencing workplace culture and its impact on employee results. Culture can either disrupt people’s ability to focus on the work, or it can reinforce and support clarity of focus, but culture is created by those working, not dictated by managers.
2. Avoiding and dealing with workplace bureaucracy, which almost always results from the creation of structure, a necessity as businesses and companies grow. Understanding and managing bureaucracy improves efficiency and economics 
3. Understanding and encouraging workplace innovation, and the direct benefits to efficiency and profitability that innovation brings about. Managers often attempt to drive innovation formally, but these efforts usually fail due to a lack of understanding what really encourages innovation at the work level — where it matters most.
   
   Who should attend?
   
   This course is designed for managers interested in directly impacting these three areas, generating greater business results through the efforts of others. It is designed for new and experienced managers seeking to understand and address these issues with planned deliberation.
   
   Learning Objectives
   
   At the conclusion of this tutorial, participants should be able to:
   • Define ways to create focus and direction for people in work groups or project teams
   • Identify an applicable set of tools to understand, diagnose and correct dysfunctional culture, bureaucratic inefficiency, and inadequate innovation