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Tuesday, June 16 • 8:00am - 9:00am
#206 L: Regulatory Agility During the COVID-19 Pandemic

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-630-L04-P; CME 1.00; IACET 1.00; RN 1.00

The current health crisis has necessitated maximum agility from both regulators and manufacturers to ensure continued supply of quality products for patients. In this session, regulators from multiple health authorities will discuss new regulatory mechanisms and flexibility of regulatory expectations to balance risk and availability.

Learning Objectives

Describe the challenges facing manufacturers related to the current COVID pandemic; Discuss regulatory approaches used by health authorities to endure continued availability of quality medicines for patients.

Chair

Christine M. V. Moore, PhD

Speaker

Update From MHRA
David Churchward, MS

FDA Update
Jeannie David, MS

EMA Update
Noël Wathion, RPh


Speakers
avatar for Christine Moore

Christine Moore

Executive Director, External Advocacy and Standards, Organon & Co., United States
Christine Moore is a founding member of Organon where she leads Global External Advocacy and Standards, with oversight for new GMP-related policy, analytical standards and compendial affairs. Christine started her career as a process development engineer, after which she moved to... Read More →
avatar for David Churchward

David Churchward

Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), Medicines and Healthcare products Regulatory Agency (MHRA)
David Churchward has been a GMP inspector with the UK MHRA since 2004 and is responsible for the strategic direction of the GxP inspectorate. He is experienced in leading the implementation of innovative regulatory approaches and provides GMP input to the MHRA’s Innovation Office... Read More →
avatar for Jeannie David

Jeannie David

Senior Program Management Officer, Drug Shortage Staff, CDER, FDA
Jeannie David has been with the Drug Shortage Staff since 2012 and has worked on several drug shortage mitigation efforts, as well as on the Guidance to Industry Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing, MAPP 5001.1 Drug Product Distribution After... Read More →
avatar for Noël Wathion

Noël Wathion

Deputy Executive Director, European Medicines Agency
Noël Wathion is the Deputy Executive Director of the EMA since February 2016. He is also the Chief of Policy. He joined the Agency in 1996, and has since held several senior managerial positions, including Head of the Post-Authorisation Evaluation of Medicines for Human Use Unit... Read More →

Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session