Session 5: February 22-25, 2010 (San Francisco, CA)

Global Registration and Approval Process

Session Chairs: Charles Grudzinskas, PhD, NDA Partners; Murray M. Lumpkin, MD, Food and Drug Administration; and Frank J. Sasinowski, JD, MS, MPH, 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: Adherence in Drug Development and Regulation | Physiologically Based Pharmacokinetics on February 25.

Lectures

• 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
• FDA Meetings: What, Why and When
• The Opportunity and Value of Scientific Advice fIn Europe
• The Role of Industry Regulatory Affairs
• New Drug Review: 2009 Update and a Look Forward
• International Regulatory Cooperation
• Orphans at FDA: The Fundamentals
• Preparing Focused and Effective Regulatory Communications
• NDA/BLA Review Outcomes, Appeal Process, and Case Studies
• Recent CDER Initiatives
• Referrals & Appeals in the EU
• Heads of Medicines Agencies: An Overview
• European Clinical Trial Directive
• Global Registration of Biologicals
• Global Registration of Biosimilar Biologicals
• Medical Device Registration
• The Role of China in Global Drug Development: A Regulatory Perspective
  
  Frontiers Workshop
• Introduction to Adherence - Definitions, Methods, Patterns in Clinical Trials
• Consequences of Variable Adherence in Clinical Trials and Clinical Medicine
• Implications and Opportunities of Variable Adherence in DD&R
• Principles of PBPK, Illustrated by use in Environmental Risk Assessment
• PBPK Applications in Drug Development
• PBPK Applications in New and Generic Drug Regulation
• Implications and Opportunities for Application of PBPK in Drug Development Panel Discussion

Case Studies

• How to Prepare for a FDA-Sponsor Guidance Meeting
• Success Factors Associated with First Cycle Approvals of NDAs/BLAs

Teaching Faculty
Terrence F. Blaschke, MD, Stanford University
Timothy R. Cote, MD, MPH, Food and Drug Administration
David W. Feigal Jr., MD, MPH, Amgen
Bruno Flamion, MD, PhD, Committee for Medicinal Products for Human Use
Charles Grudzinskas, PhD, NDA Partners
Ian Hudson, MD, Medicines and Healthcare products Regulatory Agency
Sandra Kweder, MD, Food and Drug Administration
Robert Lionberger, PhD, Food and Drug Administration
Malcolm Lloyd-Smith, MSc, Cadence Pharmaceuticals
Murray M. Lumpkin, MD, Food and Drug Administration
Xavier Luria, MD, European Medicines Agency
Carl C. Peck, MD, University of California, San Francisco
John Purves, MD, European Medicines Agency
Frank J. Sasinowski, JD, MS, MPH, Hyman, Phelps, & McNamara, PC
Geof Tucker, PhD, University of Sheffield, United Kingdom
John Urquhart, MD, University of California, San Francisco and AARDEX Group
Bernard Vrijens, PhD, AARDEX Group
Michael Vivion, PhD, EGC, Inc.
Ping Zhao, PhD, Food and Drug Administration
others to be confirmed

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