Renaissance Harborplace Hotel

Baltimore, MD, US
12 - 13 May, 2008

Advance registration for this conference has closed, but space is still available! Please contact the RAPS Solutions Center at +1 301 770 2920, ext. 200 for registration options.

Program Description

The regulatory environment for the advertising and promotion of medical devices, prescription drugs and biologic products continues to evolve with new FDA, OIG and industry initiatives. This conference offers four general sessions and two tailored tracks, specific to prescription drugs/biologics and medical devices. Leaders from industry, government and the legal profession share their expertise through lectures, discussions and case studies. The program provides an appreciation of recent congressional, state, industry and FDA initiatives and the impact they may have on advertising, promotion and medical communications teams.

Learning Objectives

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

• Summarize the latest regulations, enforcement actions, guidelines and trends affecting the advertising and promotion of medical devices, drugs and biologics;
• Identify the key regulatory issues of rapidly shifting hot topics in advertising and promotion;
• Discover regulatory applications through interactive case studies.

Who Should Attend

• Anyone involved in the regulatory aspect of advertising and promotion of health products
• Regulatory affairs professionals
• Regulatory consultants
• Compliance specialists
• Food and drug lawyers
• Marketing representatives
• Medical device attorneys
• Medical communications professionals

Professional Levels: I, II, III

General Sessions

FDA Overview and Updates
Monday, 12 May 2008
8:30–10:00 am

Moderator: Jean-Ah Kang, PharmD, Senior Regulatory Affairs Consultant, SAIC

Speakers:
Ele Ibarra- Pratt, RN, MPH, Branch Chief, APLB, CBER/FDA
Catherine Gray, Professional Review Group Leader, DDMAC
Casper E. Uldriks, MDiv, Associate Director for Regulatory Guidance and Government Affairs, Office of the Center Director/CDRH/FDA

Making A Federal Case Of It: The Role Of Advertising In Fraud And Abuse Prosecutions
Monday, 12 May 2008
10:30am–12:00pm

Moderator and Speaker:
Robert Klepinski, JD, Regulatory Attorney, Fredrickson & Byron PA
Speaker:
Mark Duval, JD, Director and Managing Partner, DuVal & Associates PA

Food and Drug Administration Amendments Act (FDAAA) of 2007 and State Law Updates
Tuesday, 13 May 2008
8:30–10:00 am

Moderator and Speaker:
Glenn Byrd, MBA, RAC, Director, Regulatory Affairs, Medimmune Inc.

Speakers:
Coleen Klasmeier, Partner, Sidley Austin LLP
Linda Pissott Reig, ESQ., Principal, Porzio Bromberg & Newman

Implications And Legal Effects Of Advertising And Promotion Of Pharmaceutical Drugs And Medical Devices
Tuesday, 13 May 2008
10:30am–12:30pm

Michael Loucks, Esq. Assistant US Attorney, US Attorney’s Office for the District of Massachusetts

Confirmed Speakers

Korina Akhondzadeh, Senior Regulatory Consultant, KARA & Associates Inc.
Alan Bennett, Managing Partner, Ropes & Gray
Glenn Byrd, MBA, RAC, Director, Regulatory Affairs, MedImmune Inc.
Mark Duval, JD, Director and Managing Partner, DuVal & Associates PA
Catherine Gray, Professional Review Group Leader, DDMAC
Ele Ibarra-Pratt, RN, MPH, Branch Chief, APLB, CBER/FDA
Jean-Ah Kang, PharmD, Senior Regulatory Affairs Consultant, SAIC
Coleen Klasmeier, Partner, Sidley Austin LLP
Robert Klepinski, JD, Regulatory Attorney, Fredrikson & Byron PA
Ilyssa Levins, Founder and President, Center for Communication Compliance (CCC)
Michael Loucks, Esq. Assistant US Attorney, US Attorney's Office for the District of Massachusetts
Alan Minsk, JD, Partner, Arnall Golden Gregory LLP
Michael C. Morton, RAC, Senior Director, Corporate Regulatory, Medtronic
Philip Phillips , MBA Executive VP and Director, Medical Device Practice, Becker & Associates Consulting Inc.
Wayne Pines, President, Regulatory Services, APCO Worldwide
Ryan Polzin, Managing Director, KJ International Resources Inc.
Linda Pissott Reig, Esq., Principal, Porzio Bromberg & Newman
Jennifer Romanski, Counsel, Porzio Bromberg & Newman
Lucy Rose, Managing Director, Life Sciences Regulatory and Capital Markets Deloitte & Touche, LLP
Sara Stults, Global Labeling & Promotion Compliance, Bristol-Myers Squibb.
Bradley Thompson, JD, Attorney, Epstein Becker & Green, PC
Casper E. Uldriks, MDiv. Associate Director for Regulatory Guidance and Government Affairs - Office of the Center Director / CDRH / FDA
Kristin M. Zielinski, Vice President, Strategic Consulting Group, Becker & Associates Consulting, Inc.

View speaker bios

Concurrent Session Topics

• Advertising and Promoting PMA Devices
• Advertising, promotion and labeling of medical devices in the EU markets
• Avoiding Pitfalls in Off Label Communications
• Clinical trials to support promotional claims
• Commercial booth activities and pre-approval communications
• Control of Medical Device Promotion by Agencies Other than FDA (FTC, USDOJ, National Advertising Division of the BBB)
• Effective Use of Medical Science Liaisons
• Elabeling
• Intended use, indications for use and claims; navigating unchartered waters in the device industry
• Introduction to Advertising and Promotional labeling
• Pre-Approval Communication About Devices
• Public Relations Considerations for Prescription Drug Promotion
• Software Integration in Medical Devices
• Training and Internal Compliance

Agenda at a Glance

APL Planning Committee

Glenn N. Byrd, MBA, RAC, Director, Regulatory Affairs, MedImmune Inc.
Jean-Ah Kang, PharmD, Senior Regulatory Affairs Consultant, SAIC
Robert J. Klepinski, JD, Regulatory Attorney, Fredrikson & Byron PA