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2020ATMPs-1988x680

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

Jun 30, 2020
11:00 AM
-
12:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Conference
  • Online

Overview

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

  • 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

Highlighted Speakers

Peter W. Marks
Peter W. Marks
U.S. FDA
Stephen P. Westover
Stephen P. Westover
Cook MyoSite Incorporated

Registration Fees

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Registration Type Price
Member $200
Non-member $200
Gov't/Health Auth./Academic $200

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