Ask The Expert: Regulatory Agency meetings and Special Designations

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Pain points

• Program delays or additional overruns when clients don’t engage or don’t engage early enough with Regulatory Agencies to gain alignment on their programs

• Failure to recognize the benefits that special regulatory designations may bring such as rolling review, more frequent Agency input on the development program and possible financial incentives, among others.

Key learnings:

Regulatory challenges on the way to a growing healthcare demand
Improve and streamline drug development
Understand various Regulatory meetings in the US and EU and how best to navigate them

Webinar Recording

Ask The Expert: Regulatory Agency meetings and Special Designations

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Speakers

Mark Lane

Vice President, Principal Consultant Development Consulting & Scientific Affair

Adair Turner

Head of US Regulatory Affairs, PharmaLex

Dr. Patrick Larcier

Senior Director of Development Consulting and Scientific Affairs, PharmaLex

Key learnings:

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