On-demandOn-demand

Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions (On-Demand)

1.0 RAC Credits Member: $0 | NonMember: $25
Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions (On-Demand)

This is a recording from October 2022


In this webinar, experts will present an analysis of FDA's accelerated approvals program, the development strategies that paved the way for these approvals and their outcomes. Currently a hot topic within the biopharmaceutical industry, there are growing concerns regarding the overall premises of the program and its exhaustiveness.

This session will cover a comprehensive analysis of the program. Join us to take a deep dive into past models and much more.


Learning Objectives

After this program, participants will be able to:

  • Assess the Accelerated Approval program through comprehensive analysis of past decisions.
  • Evaluate the benefits and risks of the Accelerated Approval program.
  • Learn from previous regulatory strategies and their outcomes.

Who Should Attend?

Regulatory Professionals


Instructors:

Chang-Hong Whitney

Sheila Galan

Sheila is a regulatory affairs professional with 13 years of healthcare industry experience including in regulatory intelligence, database management and quality assurance. She has led operational teams with a focus on developing and implementing regulatory strategies, corporate policies and initiatives to promote and ensure compliance with international regulations. Sheila is a BS graduate in Chemistry from the Autonomous University of Barcelona and holds an MS in Pharmaceutical research, development and control from the University of Barcelona.


Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

Add to Cart
 

Discover more of what matters to you

Biologics Biotechnology Clinical Trials Combination Products FDA meeting and communication strategy North America Pharmaceuticals Regulatory Intelligence/Policy Research, Design and Development

News »

  5;6;8;9;15;20;25;31;32;