Regulatory Affairs Forum (Session 205)

Monday 7 November, 13.30 – 17.00

ISPE CEUs: 0.25

The Regulatory Forum will provide an opportunity to hear from senior leaders of global regulatory agencies. Each regulatory speaker will provide a brief update on key developments with which their agency is currently concerned. A major part of the session will be interactive and participatory. Attendees will be encouraged to put their questions to this distinguished panel either by voicing their questions or by writing them on question cards submitted during the first part of the session. The regulatory agency leaders from both review and inspectorate divisions will participate.

Leaders

Speakers

• Jeff Campie, USA
• Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
• Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
• Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
• Edwin Melendez, Principle Consultant, Parexel, USA
• Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
• Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
• Julian Wilkins, Vice President, PharmaConsult US Inc, USA
• Paul Wreglesworth, Independent Consultant, United Kingdom

How You Will Benefit

• Understand global regulatory topics and perspectives
• Explain current regulatory initiatives
• Apply insights from industry questions and answers with regulators

Who Should Attend

Manufacturing industry representatives and regulatory professionals

Communities of Practice (COPs)

This session is of particular interest to existing and future members of the following ISPE Communities of Practice (COPs):

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