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Increased EMA/Industry Dialogue Needed to Address Upcoming Biopharm Regulatory Challenges, Retiring Quality Director Purves Says

Aug 21st, 2010

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The biopharmaceutical regulatory challenges confronting the EMA over the next decade – from biosimilars, advanced therapies, personalized medicine and transgenics to variations and quality by design – will require close industry/regulator dialogue and new communication channels, recently retired EMA Quality of Medicines Head John Purves stressed at CASSS’ European CMC Strategy Forum in Vienna in late May.

The criticality of open scientific dialogue and information sharing to shaping viable regulatory policies and guidance and steering the complex new products through their development, review and manufacturing stages was a central theme in Purves’ assessment of the emerging EMA landscape.

Focused on the challenges facing biopharmaceutical development in the next decade, the Vienna forum provided the European regulator a chance to take a broad view of how the EMA will need to evolve to address them.  Purves left the UK’s MCA 14 years ago to join the newly formed EMEA, where he played a key role in advancing its quality regulatory effort and policies. He retired from the agency at the end of April.

[Purves’ analysis of how the EMA will need to evolve to meet the emerging biopharmaceutical regulatory challenges and the dialogue that followed at the Vienna CMC forum is provided for subscribers beginning on page 2.]

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