Session 5: January 12-15, 2009
Global Registration and Approval Process
Session Chairs: Charles Grudzinskas, PhD, NDA Partners; Murray Lumpkin, MD, Food and Drug Administration; and Frank Sasinowski, JD, Hyman, Phelps, & McNamara, PC
Overview on mechanisms and regulatory management systems in Europe, the US and Asia. Requirements of a regulatory application, documentation and collaboration between developers and regulators. Special regulatory procedures, strategies and crisis management.
Frontiers in Drug Development and Regulatory Science Series on January 15.
- The History of the Regulation of Drugs: US, EU and Asia
- Navigating FDA Regulatory Pathways: INDs, e-INDs, NDAs/BLAs, 505(b)(1), 505(b)(2), ANDA
- EMEA and EU Registration Procedures: Centralized Procedure, Mutual
- Recognition Procedure and Decentralized Procedure
- The Opportunity and Value of FDA-Sponsor Meetings
- The Opportunity and Value of Scientific Advice from CHMP and National Authorities
- Experience with Global Regulatory Approval Procedures and The Role of Industry Regulatory Affairs
- International Regulatory Cooperation
- Orphan Drug Pathway: US and EU Perspectives
- Preparing Focused and Effective Regulatory Communications
- NDA/BLA Review Outcomes, Appeal Process, and Case Studies:
- ”Approved,” “Approvable” & “Not Approved”
- FDA Critical Pathway and Recent Emerging Issues
- Referrals & Appeals in the EU
- Heads of Medicines Agencies’ Strategy Paper: Input of National Competent Authorities
- European Clinical Trial Directive
- Global Registration of Biologicals
- Follow-on Biologics: Pioneer Perspective
- Follow-on Biologics: Generic Perspective
- US Registration of Devices
- EU and Asia Registration of Devices
- Risk Evaluation and Mitigation Strategies (“REMS”)
- Drug Development in Asia
Teaching Faculty
Eric Abadie, MD, Committee for Medicinal Products for Human Use, European Medicines Agency and Agence Française de Sécurité Sanitaire des Produits de Santé
Timothy Cote, MD, MPH, Food and Drug Administration
Marie Dray, Dray Regulatory Associates-International
David Feigal, MD, MPH, Amgen
Alberto Grignolo, PhD, PAREXEL Consulting
Charles Grudzinskas, PhD, NDA Partners
Jack Henningfield, PhD, Pinney Associates
Sandra Kweder, MD, Food and Drug Administration
Zili Li, MD, PhD, Merck Research Laboratories
Murray Lumpkin, MD, Food and Drug Administration
Xavier Luria, MD, European Medicines Agency
Bruce Mackler, PhD, JD, Independent Consultant
Frank Sasinowski, JD, Hyman, Phelps, & McNamara, PC
Michael Vivion, EGC, Inc.
Prof. Kent Woods, Medicines and Healthcare products Regulatory Agency
Janet Woodcock, MD, Food and Drug Administration
