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Building a Regulatory Landscape to Support CMC Innovation
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Advanced

Senior leaders from industry and regulatory agencies will discuss the role of cooperation across regulatory bodies to facilitate innovation in the CMC/product quality sector. Senior leaders will discuss how, despite various internal and external pressures, an agile path forward can be found to advance innovative and high quality medicines.

Learning Objectives

Describe initiatives to streamline regulatory assessment/inspection; Recognize how regulatory initiatives can facilitate innovation in CMC; State comparing perspectives from senior leaders regarding regulatory initiatives and reguatory advancements.

Chair

Demetra Macheras, MBA

Speaker

Panelist
Jennifer McCafferty, PhD


Speakers
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
avatar for Jennifer McCafferty

Jennifer McCafferty

Senior Vice President, Regulatory CMC and Quality Assurance, Merck, United States
Jennifer McCafferty is Senior Vice President, Quality Assurance and Regulatory CMC in Merck Research Laboratories. Jennifer’s more than 25-year career includes leadership positions across analytical sciences, factory and CMO operations, quality systems, quality control, CMC regulatory... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

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