Plenary 5: Center Updates

Moderator(s)

• 

  Susan Schniepp

  Distinguished Fellow
  Regulatory Compliance Associates Inc.
  Las Vegas, Nevada, United States

Regulatory Panelist(s)

• 

  Matthew Lucia, DVM

  Director, Office of New Animal Drug Evaluation, CVM
  U.S. FDA
  Rockville, Maryland, United States
• 

  Peter Marks, MD, PhD

  Director, CBER
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  Judith McMeekin, PharmD

  Associate Commissioner for Regulatory Affairs, ORA
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  Douglas Throckmorton, MD

  Deputy Director of Regulatory Programs, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

Regulatory Presenter(s)

• 

  Peter Marks, MD, PhD

  Director, CBER
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  Judith McMeekin, PharmD

  Associate Commissioner for Regulatory Affairs, ORA
  U.S. FDA
  Silver Spring, Maryland, United States

  Presentation Handout
• 

  Steven Solomon, DVM, MPH

  Director, CVM
  U.S. FDA
  Rockville, Maryland, United States

  Presentation Handout
• 

  Douglas Throckmorton, MD

  Deputy Director of Regulatory Programs, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

  Presentation Handout

The global regulatory landscape is evolving, and innovative approaches to product life cycle and quality paradigms are met by new real-life challenges and complexities every day – patient-individualized medicines, supply challenges for legacy products, transition to new technologies, highly globalized supply chains. How will U.S. FDA continue to optimize its mission to safeguard the quality, safety, and effectiveness of medicines for patients even with these manufacturing and supply challenges? After introductory presentations, your questions on these and other issues will be posed to FDA executive management from various FDA Centers! In a virtual round table format, the conversation will focus on these issues that are often cross-cutting across different centers and relevant to the entire pharmaceutical space.

Presentations:

• 09:45 – 10:06 EDT

  CBER Updates
  

  Regulatory Presenter: Peter W. Marks, MD, PhD – U.S. FDA
• 10:06 – 10:22 EDT

  CDER Updates
  

  Regulatory Presenter: Douglas R. Throckmorton, MD – U.S. FDA
• 10:22 – 10:40 EDT

  CVM Updates
  

  Regulatory Presenter: Steven M. Solomon, DVM, MPH – U.S. FDA
• 10:40 – 11:03 EDT

  ORA Updates
  

  Regulatory Presenter: Judith A. McMeekin, PharmD – U.S. FDA
• 11:03 – 11:15 EDT

  Live Q&A (P5)
  

  Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.

  Regulatory Panelist: Matthew A. Lucia, DVM – U.S. FDA

  Regulatory Panelist: Peter W. Marks, MD, PhD – U.S. FDA

  Regulatory Panelist: Judith A. McMeekin, PharmD – U.S. FDA

  Regulatory Panelist: Douglas R. Throckmorton, MD – U.S. FDA