Sponsored Webcast: Retrospective Analysis of FDA’s Accelerated Approvals and Conversions

1.0
RAC Credits
Virtual Programs Virtual Programs
Wednesday, 05 October 2022 (11:00 AM) - Wednesday, 05 October 2022 (12:00 PM) Eastern Time (US & Canada)

In this webcast, 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 a comprehensive analysis of past decisions.
  • Evaluate the benefits and risks of the Accelerated Approval program.
  • Learn from previous regulatory strategies and their outcomes.

Registration Fees & Deadlines

Free


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.


Cancellations

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.


Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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