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Collaborative Review & Reliance – Grasping the Opportunity
Session Chair(s)
Andrew Deavin, PhD, MS
Senior Director, Regulatory Affairs
GSK, Belgium
The session will focus on the current status of reliance and recognition between European and other global regulators. The speakers will cover flagship topics of high interest to industry, including the ICMRA pilot programs, the experience of industry innovators in developing a global vaccines reliance pilot and reflections on the status of reliance and recognition in GMP. Regulators and industry will offer reflections and proposals for how the future state can increasingly use reliance and recognition to enable more harmonized and streamlined approaches to assessment of the CMC dossier and assurance of GMP, with the ultimate goal of enabling more accelerated and secure supply of medicines to patients.
Learning Objective : - Lessons learned during participation in the ICMRA Pilot on Collaborative Assessment of a Post-Approval Change Management Protocol (PACMP). - Interactions with the ICMRA working group for the submission and the review of a PACMP to support a drug product site addition. - Highlight guidance differences and areas where convergence may be reached amongst Regulators
Speaker(s)
Global Approval Timelines and need for Reliance
Mark Pellett, PhD, MSc, RPh
AstraZeneca, United Kingdom
Senior Director and Group Manager
Regulator Opinion - Panel discussion and Q&A (1)
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
Panelist
Marie Valentin, PharmD
WHO, Switzerland
Team Lead, Facilitated Product Introduction
Panelist
Reem Al-Naimat
Jordan Food and Drug Administration (JFDA) , Jordan
Consultant Pharmacist, Head of Manufacturing Sites Accreditation Unit
ICMRA Collaborative Assessment Pilot: share learnings from a PACMP submission to 6 Agencies
Sylvie Meillerais, MSc
MSD Belgium, Belgium
Director Global CMC Policy
1 dossier & 1 timeline for a PAC, the story of a regulatory reliance pilot!
Lyne Le Palaire, MSc
Sanofi, France
Quality Advocacy Leader
Inspection framework: Future opportunities
Stephan Roenninger, DrSc
Amgen (Europe) GmbH, Switzerland
Director, Quality External Affairs
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