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HARMONISATION – PITFALLS AND HOW CAN WE SPEED IT UP?
Session Chair(s)
Jean-Louis Robert, PhD
Former CHMP/CVMP QWP Chair
Luxembourg
In the world of globalisation, harmonisation of requirements in the pharmaceutical area has become a real challenge. The session will present a brief history of what has been achieved so far (successes and pitfalls) for instance within EU, ICH including Global Cooperation Group, PICs, the EU/US work sharing programme. Representatives from industry will present their experience and expectations for the future.
Speaker(s)
Regulatory Harmonisation Initiatives- past present and future
Jean-Louis Robert, PhD
Luxembourg
Former CHMP/CVMP QWP Chair
Collaboration between Regulators and Work Sharing Experiences – A way forward or an additional burden for industry?
Graham Cook, PhD
Pfizer Global Quality Intelligence and Compendial Affairs, United Kingdom
Senior Director
The Need for Harmonisation from the API Manufacturers’ Point of View and How to Encourage Regions to Align Requirements
Matthew James Moran, MBA
Cefic-Apic, Ireland
Vice President
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