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

1.0 RAC Credits Member: $0 | NonMember: $20
Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions (On-Demand)

This is a recording from October 2022


In this webinar, our team will present an analysis of FDA's Accelerated Approvals, the development strategies that paved the way for these approvals and their outcomes. This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.

It is currently a hot topic within the Biopharmaceutical industry. There is growing concerns regarding the exhaustiveness of the Accelerated Approval program as it is currently established, and it is being questioned whether the program should be revisited.

By participating in this workshop, attendees will be able to:

  • Understand NMPA’s regulations, processes and requirements for IVD product registration.
  • Identify key factors that would affect regulatory strategies and prepare for necessary adjustments.
  • Gain up-to-date knowledge of current requirements and practices.
  • Discuss their specific issues with presenters and other participants.

Led by instructors who are veteran regulatory managers, this workshop will also incorporate personal experience, knowledge, up-to-date information and best practices.

This workshop is suitable for professionals with more than three years of experience, looking to broaden their knowledge base on international regulations or to focus on the Chinese market in the near future.

This workshop will continue its tradition as a highly interactive forum for speakers and attendees. Speakers welcome and encourage questions and live discussions. Please submit your questions to the workshop chairperson or simply ask questions live during the workshop. 

In order to accommodate our RA colleagues from around the world, this workshop shall be held online and in 3 consecutive mornings (US eastern standard time) of July 13-15, 9 am – 12:30 pm, ET (3 days).


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.
  • Gain up-to-date knowledge of current requirements and practices.
  • 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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