Plenary 2: Emerging Stronger through Collaboration

Moderator(s)

• 

  Valerie Whelan

  Vice President, Quality
  Thermo Fisher Scientific
  Ballycoolin, Dublin, Ireland

Panelist(s)

• 

  Melissa Seymour, MBA

  Chief Quality Officer
  Biogen
  Raleigh, North Carolina, United States

Regulatory Panelist(s)

• 

  Ashley Boam, MSBE

  Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  CDR Emily Thakur, RPh

  Team Leader, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

Regulatory Presenter(s)

• 

  Ashley Boam, MSBE

  Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

  Presentation Handout

A wise man said that “Perseverance is not a long race; it is many short races one after the other.”

Over the last eighteen months, we have won many of these short races together as we have adapted to the changing landscape driven by the pandemic. In this session we will hear from regulatory and industry leaders on those races; the practical challenges we have overcome from the simple to the complex, the transformative level of collaboration we have seen internally and externally, the innovation that we have accelerated and the changes that will enable us to emerge stronger.

Presentations:

• 11:30 – 11:48 EDT

  Engaging Stronger Together: A Regulatory Perspective
  

  Regulatory Presenter: Ashley B. Boam, MSBE – U.S. FDA
• 11:48 – 12:09 EDT

  Covid-19 Industry Perspective: Practical Challenges and Transformations
  

  Presenter: Melissa S. Seymour, MBA – Biogen
• 12:09 – 13:00 EDT

  Live Q&A (P2)
  

  Moderator: Valerie Whelan – Thermo Fisher Scientific

  Panelist: Melissa S. Seymour, MBA – Biogen

  Regulatory Panelist: Ashley B. Boam, MSBE – U.S. FDA

  Regulatory Panelist: CDR Emily T. Thakur, RPh – U.S. FDA