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Tuesday, June 18 • 1:15pm - 2:15pm
#253: Platform Technology Designation: Opportunities and Challenges for Implementation

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-591-L04-P; CME 1.00; RN 1.00

This forum will review the key components of the new FDA Platform Technologies Designation program. A panel of experts will provide their perspectives on the proposal and discuss opportunities and challenges related to its implementation.

Learning Objectives

Describe the key attributes of the proposed Platform Technology Designation Program as described by the anticipated FDA draft guidance; Discuss stakeholder perspectives about the new designation program; Describe anticipated opportunities and challenges related to its implementation.

Chair

Andrea Doyle

Speaker

Panelist
Rachael Anatol

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Monica Veldman


Speakers
avatar for Rachael Anatol

Rachael Anatol

Deputy Super Office Director, Office of Therapeutic Products, CBER, FDA, United States
AD

Andrea Doyle

Head, Global Regulatory Affairs, Neurology, Sanofi, United States
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
MV

Monica Veldman

Director of Global Regulatory Policy, Alliance for Regenerative Medicine, United States

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum