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Thursday, June 18 • 5:00pm - 6:00pm
#556 OD: ON DEMAND - Demystifying Global Device Requirements: High Level Comparison of Current Expectations

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Component Type: Session
Level: Basic

The complexity and dynamic environment of drug-device regulations can be confusing. This session will compare and contrast global regulatory expectations, as well as highlight key CMC questions as new requirements take effect.

Learning Objectives

List key global regulatory agencies that review drug-device submissions and compare the high-level differences in their regulatory requirements; Describe how risk assessment is integrated into regulatory expectations for drug-device combinations; Identify the broad range of products that fit within the drug-device scope.


Celeste Frankenfeld, PhD


Lifecycle Considerations for Drug Device Combination Products: Scientific and Regulatory Perspectives
Ramesh Raghavachari, PhD

Understanding Regulatory Expectations for Drug Device Products in the EU
Janine Jamieson, PhD, MPharm

Challenges in the Dossier Presentation of Combination Product Control Strategy: Integration of QbD and Design Control
Deborah M. Schachter, PhD, MBA

avatar for Celeste Frankenfeld

Celeste Frankenfeld

Director, Merck & Co., Inc., United States
Celeste Frankenfeld Lamm, Ph.D., is currently a Director of Global Regulatory Affairs – CMC at Merck & Co, Inc. with 14 years of industry experience. In this capacity she is responsible for regulatory strategy, engagement with regulatory authorities, and preparation of clinical... Read More →

Janine Jamieson

European Editor, IPQ Publications
Janine was a pharmaceutical assessor in the Medicines Licensing Division of MHRA from 1997 until June 2016; the latter 10 years with focus on device-drug combination (DDC) products, carrying out consultations for several EU Notified Bodies. She advised on drug-device combination product... Read More →
avatar for Deborah Schachter

Deborah Schachter

Scientific Director, Dossier Development & Operations, Small Molecule Pharma Dev, Janssen Research & Development, LLC
Deborah Schachter has more than 20 years of combination product experience. In her current role, Dr. Schachter is responsible for the strategy development and execution of the combination product dossier content and standards for both small molecule and biologic drug product CTA and... Read More →
avatar for Ramesh Raghavachari

Ramesh Raghavachari

Chief, Branch I, DPMA1, OLDP, OPQ, CDER, FDA
Ph.D - Temple University, Philadelphia, PA Currently a Chemist at FDA/CDER, has been with FDA since 2003.

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session