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Monday, June 28 • 2:30pm - 3:30pm
#136 SL: Parallel Scientific Advice: Increasing International Dialogue Early in the Product Lifecycle

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-543-L04-P; CME 1.00; IACET 1.00; RN 1.00

The Parallel Scientific Advice (PSA) procedure is a process for EMA and FDA to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and biologics). Such interactions are expected to increase dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product, provide a deeper understanding of the bases of regulatory decisions, optimize product development, and avoid unnecessary testing replication or unnecessary diverse testing methodologies. This session will be led by EMA and FDA PSA participants and program managers, as well as a participant offering the industry perspective. Attendees will better understand the PSA procedure, how to apply, and expectations on outcomes.

Learning Objectives

Explain the Parallel Scientific Advice (PSA) procedure framework and timelines; Identify best candidates for PSA and best practices for request letters; review statistics on utilization of the PSA procedure; Describe Industry’s and each Agency’s unique perspective and contribution to PSA.

Chair

Shannon Thor, PharmD, MS

Speaker

PSA: FDA Division Perspective
Kelly Richards, MSN, RN, RAC

PSA: EMA Perspective
Thorsten Vetter, DrMed

PSA: A Sponsor Perspective
Petra Pavlickova, PhD, RAC


Speakers
avatar for Shannon Thor

Shannon Thor

International Policy Analyst, Office of Global Policy & Strategy, Europe Office, FDA, United States
Lieutenant Commander Shannon Thor is a pharmacist and officer in the United States Public Health Service, serving as an international policy analyst in FDA's Europe Office, working closely with European regulatory counterparts to accomplish international public heath goals. Previous... Read More →
avatar for Petra Pavlickova

Petra Pavlickova

Associate Director, Regulatory Affairs, Bristol-Myers Squibb Company, United States
Petra Pavlickova is an Associate Director of Regulatory Affairs at Bristol Myers Squibb (BMS). In her current role, Petra is leading regulatory strategy and submissions for new immunology and fibrosis pharmaceutical products in US. She joined BMS two years ago. Prior to joining BMS... Read More →
avatar for Kelly Richards

Kelly Richards

Senior Regulatory Health Project Manager, Gastroenterology , ORO, OND, CDER, FDA, United States
Senior Regulatory Health Project Manager, Gastroenterology with FDA's Division of Regulatory Operations for Immunology and Inflammation, Office of Regulatory Operations in the Center for Drug Evaluation and Research
avatar for Thorsten Vetter

Thorsten Vetter

Senior Scientific Officer, Scientific Advice, European Medicines Agency, Netherlands
MD, Board certified Clinical Pharmacologist, Senior Scientific Officer, Scientific Advice Office, European Medicines Agency

Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session