Communicating with FDA During Drug Development

Overview

Communicating with FDA During Drug Development

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Event Agenda

DATE: Wednesday, 15 June 2022

TIME:    6:00 – 6:05 PM   Welcome and Announcements

               6:05 – 7:05 PM   Program Presentation

               7:05 – 7:30 PM   Q & A

LOCATION:  This is an ONLINE event on zoom virtual platform       

Program Details

Communication with FDA is important throughout the drug development process and continues post-marketing. Opportunities to solicit input from FDA, or present the sponsor’s information, can occur in very different ways that can be formal or informal (e.g. phone calls, email, submissions, meetings).

In this presentation, you will learn about the different opportunities to communicate with FDA. The discussion will include an overview of when, how, and why these communications are important and best practices to consider.

Speaker Biographies

Mary Wilhelm MSc, MSRA, DRSc, RAC (EU, US) has over thirty years of experience within the pharmaceutical and biotechnology industries. She is currently a Global Regulatory Lead at Ascendis Pharma and is responsible for the development of regulatory strategies for the company’s growth hormone program. In this role, Mary brings experience in developing regulatory intelligence and strategy, identifying regulatory risk mitigation and contingency plans, interacting with domestic and international regulatory agencies, and optimizing filing outcomes for both investigational and commercial drug products. Mary has a strong background in quality assurance and quality control and has supported the manufacture of food additives, bulk excipients, and cosmetic ingredients.

Mary holds a Doctorate in Regulatory Science from the School of Pharmacy at the University of Southern California (USC). In her dissertation work, she studied “Regulatory Agreements for Drug Development Collaboration” which explored the views of industry professionals on the need for and current use of standalone regulatory agreements. Mary also holds Masters degrees from San Diego State University in Regulatory Science, and from Purdue University in Chemistry. She has earned Regulatory Affairs Certification from the Regulatory Affairs Professional Society for both the EU and US.

Mary is also an Adjunct Faculty at San Diego State University and serves as a Guest Lecturer at the University of Southern California at the School of Pharmacy.

Contact

[email protected]

Pricing – Online – Registration (May 26, 2022 – June 14, 2022)

Cancellation Policy

There will be no refunds for cancellations.