PDA Webinar: Regulatory Challenges, Perspectives, and Convergence to Progress ATMPs

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We’re proud to welcome Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA, who is joining us for this final webinar in 2020 PDA Advanced Therapy Medicinal Products Month Webinar Series!

As more and more companies are transitioning into cell and gene manufacturing, it is imperative that regulatory requirements allow for an acceptable risk-based approach that can be applied across manufacturing sites.

This webinar will highlight global regulatory challenges, current regulatory thinking, and efforts that are being proposed and/or undertaken to promote convergence in global regulatory approaches for cell and gene therapy manufacturing.

In addition to the presentation by Dr. Marks, we will be hearing an industry perspective on lessons learned from an RMAT designation request.

Following the presentations, get your questions answered during a live 30-minute Q&A session with the speakers.

This webinar is presented as part of the 2020 PDA Advanced Therapy Medicinal Products Month.

Agenda

Discover What's Happening Each Day
Day 1 30 Jun
Tuesday, 30 June

11:00 a.m. – 11:30 a.m.
Moving Toward Global Regulatory Convergence for Advanced Therapy Medicinal Products
Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA

11:30 a.m. – 12:00 p.m.
Lesson Learned from an RMAT Designation Request
Stephen P. Westover, Director of Regulatory Affairs, Cook Myosite Incorporated

12:00 p.m. – 12:30 p.m.
Q&A with Speakers

Registration

Pricing Options

Standard Registration

Member Price

$200

GovernmentMember Only

$200

Health AuthorityMember Only

$200

AcademicMember Only

$200

Non-Member

$200

See Qualifying Criteria for Member Types.

Sponsor information will be available soon

We're currently finalizing our list of sponsors and will share the details shortly.

Become a Sponsor and/or Exhibitor

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Boost your brand and visibility by becoming an exhibitor at the PDA Webinar: Regulatory Challenges, Perspectives, and Convergence to Progress ATMPs! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.

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