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Regulators Discuss Harmonization & Innovation, Regulatory Agility & Speed, & Workforce Skills

ISPE

Conocchia explained that discussions were being held to extend the EU - US MRA to include veterinary products as well as vaccines and blood products. Conocchia repeated that the EU QIG was willing and available to act as a partner with learning about new technology developments. In summary, better quality oversight is needed.

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Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View

ISPE

The panellists included: Roberto Conocchia GMP Technical Lead European Medicines Agency (EMA) Rick Friedman Deputy Director, Office of Manufacturing Quality FDA/CDER Alan Moon Lead Senior GMDP Inspector MHRA The discussions were moderated by Mark Birse and Jean-Francois Duliere. ™ and Annex 1 Conference.