Regulatory Essentials: US Preconference Workshop Agenda

13 September 2009
Room 113 AB

Program Chair: Elaine Messa, RAC, director, medical device quality systems and compliance practice, Becker & Associates Consulting Inc.

7:00 - 8:00 am Registration and Continental Breakfast
8:30 - 8:40 am Welcome

Elaine Messa, RAC, director, medical device quality systems and compliance practice, Becker & Associates Consulting Inc.
8:40 - 8:55 am Brief History of Medical Product Regulation: FDA Organizational Overview

Elaine Messa, RAC, director, medical device quality systems and compliance practice, Becker & Associates Consulting Inc.
8:55 - 10:30 am Overview of Drugs and Biologics

This session will review tragic events that have driven regulation of drugs and biologics in the US including the impact of the Food and Drug Administration Amendments Act of 2007 and the US Supreme Court decision in Wyeth vs. Levine. An overview of FDA’s structure and its oversight of drugs, biologics, medical devices and combination products will be presented. Various regulatory strategy elements throughout the product lifecycle (from discovery to commercialization) will be discussed, such as formal meetings with FDA, orphan designation, fast track designation, accelerated approval and special protocol assessments. Format and content information, maintenance obligations and change requirements after approval (including postmarketing studies and postmarketing requirements) for Investigational Drug Applications (INDs), New Drug Applications (NDAs) and Biologics License Applications (BLAs) in the Common Technical Document (CTD) format will be given. Risk management plans and Risk Evaluation and Mitigation Strategies (REMS) will be discussed.

Christine Phillips, PhD, RAC, manager, Eli Lilly and Company
10:30 - 11:00 am Refreshment Break
11:00 - 11:45 am Overview of Drugs and Biologics (continued)

Christine Phillips, PhD, RAC, manager, Eli Lilly and Company
11:45 am - 12:30 pm Overview of Medical Devices

This session will differentiate the concepts of drugs and biologics from those of medical devices emphasizing elements of product overlap. Information will be presented interactively with interspersed examples and experiences for the basics of medical device laws, key points for product development, device classification, key submission types, corrections and removals and recalls.

David Chadwick, PhD, RAC, regulatory scientist, Cook Inc.
12:30 - 1:30 pm Lunch
1:30 - 2:30 pm Advertising, Labeling and Promotion for Drugs, Biologics and Medical Devices

The regulatory environment for pharmaceuticals and medical devices continues to evolve as new US Food and Drug Administration (FDA), Office of the Inspector General (OIG) and industry initiatives surface. This session will provide a broad overview of advertising and promotional labeling as well as specific information regarding the current regulatory climate through interactive discussion and real-life examples.

Glenn Byrd, RAC, director, regulatory affairs, Medimmune LLC
2:30 - 3:00 pm Postmarketing Requirements for Drugs and Biologics

This session will review safety reporting obligations and maintenance of New Drug Applications (NDAs) and Biologic License Applications (BLAs). Information on safety reporting obligations, including adverse drug experiences, the need for postapproval periodic adverse event reporting, as well as annual reporting requirements and field alerts will be given. Additional requirements for biologics regarding establishment standards, retention samples, product deviations and distribution reports will be given along with maintenance requirements such as reporting on the status of postmarketing commitments.

Christine Phillips, PhD, RAC, manager, Eli Lilly and Company
3:00 - 3:30 pm Refreshment Break
3:30 - 4:00 pm Postmarketing Requirements for Medical Devices

This session will review adverse event reporting obligations and maintenance of premarket applications (PMAs). Information on safety reporting obligations, including adverse device experiences, medical device reporting and annual reporting requirements will be presented along with maintenance requirements such as reporting on the status of postmarketing commitments.

David Chadwick, PhD, RAC, regulatory scientist, Cook Inc.
4:00 - 4:45 pm Compliance and Enforcement

Elaine Messa, RAC, director, medical device quality systems and compliance practice, Becker & Associates Consulting Inc.
4:45 - 5:00 pm Question and Answer
5:00 pm Adjourn