Hyatt Regency Vancouver
Vancouver, BC
31 July-1 August 2008

Program Description

This interactive two-day program challenges experienced regulatory professionals to think strategically about issues surrounding product commercialization following FDA approval. The areas of focus include postmarket requirements, impact of manufacturing changes, key advertising and promotional issues, worldwide safety surveillance and reporting, label expansion and the challenges of global market growth. Changes to postmarket requirements resulting from the recent Food and Drug Administration Amendments Act of 2007, and which impact virtually all approved products, will also be addressed.

To be successful, seasoned regulatory professionals must navigate the often “gray” areas, strategize effectively, establish priorities and communicate recommendations to management based on many considerations. In this intensive workshop, attendees are placed into case study groups with the goal of developing effective and strategic approaches to resolve critical regulatory issues encountered during this key phase of the product lifecycle. Case scenarios for each session are selected based upon participants’ product responsibilities in the relevant areas of biologics, small molecule drugs, combination products and medical devices to ensure each attendee has an opportunity to focus on his or her areas of interest.

Specific case scenarios will be chosen from among the following topical areas:

• Postmarket study commitments
• Reimbursement issues
• Inspections
• Postapproval manufacturing reports
• Corrections and removals / product recalls
• Receiving and responding to Warning Letters
• Off-label usage
• Direct-to-consumer advertising
• Adverse event reporting
• FDAAA requirements
• Label expansion

Program leaders share their experience in addressing regulatory compliance issues in the areas covered by the program. Lecture sessions address key regulatory issues and challenges of the postlaunch environment, including late-breaking topics. The program emphasizes practical problem-solving using real-world situations, buttressed by laws, regulations and guidances, along with projections for the future.

In addition to strengthening participants’ business and technical skills as well as regulatory expertise, this program provides a unique opportunity for seasoned professionals to expand their professional network of senior-level colleagues and to jointly prepare to deal with an increasingly aggressive regulatory environment.

Learning Objectives

At this program’s conclusion, participants should be able to:

• Develop creative solutions to difficult regulatory issues encountered during the postlaunch phase of healthcare product introduction;
• Apply problem-solving skills to a broad range of postlaunch regulatory challenges;
• Resolve critical safety surveillance concerns and address the impact of these and other postapproval issues.

Who Should Attend

Designed for regulatory professionals with six or more years of regulatory experience and a high level of responsibility, this program is of particular value to those working in a regulatory business strategy and management environment. It is also beneficial to those wishing to network with peers to enhance their knowledge and insight and to broaden the scope of their regulatory expertise. Professionals whose firms are developing medical devices, pharmaceuticals, biologics and/or combination products will benefit from this meeting.

Levels: Levels III, IV

Program Committee

Kimber L. Poffenberger, PhD, joined Iomai as Vice President, Regulatory Affairs, in November 2005. She leads the regulatory strategy, submissions and compliance activities for all products. Poffenberger has more than 18 years experience in the pharmaceutical/biotech field, including 10 years at the Food and Drug Administration. She has worked with authorities in the United States, Canada, the United Kingdom and the European Union and led successful submissions at investigational, market application and postmarket product stages. Most recently, she served as senior director of regulatory affairs at MedImmune Inc., where she headed the vaccines regulatory group responsible for FluMist and all other vaccines. Poffenberger has also worked as a regulatory affairs director for Baxter BioSciences. She holds a BS in biochemistry from Carnegie-Mellon University and a PhD in microbiology from the University of Chicago.

Cheryl L. Shea, RAC*, has more than 20 years experience in the medical device area, for both large and emerging companies. She has been responsible for the completion of a significant number of regulatory submissions including 510(k)s, IDEs and PMAs. Her track record also includes the design, initiation and management of successful multicenter clinical trials. Shea has spearheaded a product from conception through the preclinical, clinical and regulatory process to market, including modular PMA development and submission leading to a panel presentation. Her clinical knowledge includes cardiology, cardiovascular, radiology, oncology, gynecology and orthopedics. She has also led the development and implementation of full Quality Systems for three companies to date. Shea received her BSN from California State University, Fullerton and is currently pursuing a Master’s in organizational leadership at Gonzaga University. Previously, she has worked for Baxter Edwards Healthcare, ArthroCare Corporation and CryoGen Inc., and as an independent consultant. Since 2005, she has been VP of RA/QA for Cardiac Science Corporation. Shea also holds professional certification (RAC) from the Regulatory Affairs Professionals Society and participated in the 2007 review and update of the society’s Fundamentals of US Regulatory Affairs.

Evan B. Siegel, PhD*, founded Ground Zero Pharmaceuticals Inc. in 1999 from his consulting firm, Ground Zero Strategics Ltd. He served as a consultant and later Chief Executive Officer of OXO Chemie Inc. and was Director of Regulatory Consulting Services and Principal Regulatory Scientist for Quintiles Inc. Siegel has held positions as a toxicology reviewer at the US Food and Drug Administration and was Supervising Toxicologist and Chief of Special Services for the Food and Drug Branch, California Department of Health Services. He has served in regulatory affairs and executive positions in both the pharmaceutical industry (Astra, Syntex, Medical Science Systems and OXO Chemie) and trade association environments. Siegel is an Adjunct Professor in the Centre for Integrated Preclinical Drug Development, University of Queensland, Australia. He holds an MS and PhD in virology and molecular biology from the Waksman Institute of Microbiology at Rutgers University.

*Program Committee member will attend the meeting.

Agenda at a Glance