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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)
Mark Pellett, PHD, MSC, RPH
Senior Director and Group Manager, AstraZeneca, United Kingdom
Global Approval Timelines and need for Reliance
Evdokia Korakianiti, PHD, MSC
Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Regulator Opinion - Panel discussion and Q&A (1)
Marie Valentin, PHARMD
Team Lead, Facilitated Product Introduction, WHO, Switzerland
Panelist
Reem Al-Naimat
Consultant Pharmacist, Head of Manufacturing Sites Accreditation Unit, Jordan Food and Drug Administration (JFDA) , Jordan
Panelist
Sylvie Meillerais, MSC
Head of CMC Excellence, Institut De Recherches Internationales Servier, France
ICMRA Collaborative Assessment Pilot: share learnings from a PACMP submission to 6 Agencies
Lyne Le Palaire, MSC
Quality Advocacy Leader, France
1 dossier & 1 timeline for a PAC, the story of a regulatory reliance pilot!
Stephan Roenninger, DRSC
Director, Quality Compliance External Affairs , Amgen (Europe) GmbH, Switzerland
Inspection framework: Future opportunities
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