FDA Regulatory And Compliance Symposium Offers Continuing Education Credit
Cambridge, MA - The FDA Regulatory and Compliance Symposium, www.FDASymposium.com, announced that it offers twelve categories of continuing education credits to those attending the Symposium.
CONTINUING EDUCATION CREDITS OFFERED:
The FDA Symposium offers the continuing eeucation credits list at:
www.fdasymposium.com/education.html.
TRACKS AND TOPICS:
The FDA Regulatory and Compliance Symposium will feature focused tracks of expert advice and analysis, including:
- Manufacturing/GMPs - reducing risks and improving quality while controlling costs
- Product Development - reducing risks in clinical trials and speeding product approval
- Advertising and Marketing - reducing risks and minimizing liabilities from off-label promotion, CME, DTC and more
- Benchmarking - measuring your risk management strategies against the best companies and best practices worldwide
- FDA's Risk Management Guidance - understanding and meeting FDA's latest expectations in improving drug safety
- Enforcement and Inspections - preparing for systems-based inspections and building a culture of compliance
- Pharmacovigilance - managing risks and implementing best practices in drug safety monitoring and reporting
- Peter Barton Hutt, former FDA chief counsel, now an attorney with Covington & Burling
- Mark Brown, former FDA associate chief counsel for enforcement, now partner with King & Spalding
- Martin Browning, former FDA investigator and special assistant to the FDA associate commissioner for regulatory affairs, now president of EduQuest
- Anthony Celeste, former FDA director of regional operations, now senior vice president of AAC Consulting
- Larry Gibbons, corporate vice president for global quality, Baxter Healthcare
- Linda Horton, former FDA director of international policy, now partner at the Brussels, Belgium office of Hogan & Hartson
- Steven Johnson, vice president and assistant general counsel, Allergan
- Michael Kowolenko, senior vice president of pharmaceutical operations and technology, Biogen Idec
- Geoff Levitt, vice president and general counsel, Wyeth Pharmaceuticals
- Roger Louis, chief compliance officer, Genzyme
- Louis Morris, member of FDA's Drug Safety and Risk
- Management Advisory Committee and president of Louis A. Morris Associates
- Welton O'Neal, associate vice president for medical affairs, sanofi-aventis
- Claudio Pincus, president of The Quantic Group
- Wayne Pines, former FDA deputy commissioner for communications, now president of regulatory services, APCO Worldwide
- Sidney Schnoll, executive medical director for risk management and health policy, Purdue Pharma
- William Sietsema, vice president of clinical regulatory strategic planning, Kendle
- Nancy Singer, former special counsel to AdvaMed and founder AdvaMed's Medical Technology Learning Institute
- John M. Taylor III, former FDA Associate Commissioner for Regulatory Affairs
- Daniel Troy, former FDA chief counsel, now an attorney with Sidley Austin Brown & Wood
- L. Stephan Vincze, ethics and compliance officer, TAP Pharmaceuticals
- Matthew Weinberg, president, THE WEINBERG GROUP
Take your place in one of the world's most prestigious academic settings to become an expert on new industry practices and federal regulations affecting your risk management. You'll understand how the latest changes inside the FDA are translating into drug safety requirements and new opportunities to win faster approvals and greater market share. Plus, you'll meet and share ideas with your peers.
WHO WILL BENEFIT:
Register now to lock in the early-bird rate. Additional discounts are available for groups of three or more, so you can afford to bring your entire team. Include senior executives, compliance officers and managers - especially those responsible for the oversight of:
Regulatory affairs
Pharmacovigilance
Drug manufacturing
Quality management systems
Medical affairs
Clinical research
Risk management
Sales and marketing
Labeling
Legal affairs
SOURCE: FDA