Webinar Recording

What you need to know to submit Study Data to FDA & what the new FDA Technical Rejection Criteria means for you

On-Demand 1 Hour Your Desk!

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Speakers

Adair Turner

Principle, Consultant, Director RegOps, PharmaLex

Parul Patel

Senior Product Consultant, LORENZ Life Sciences Group

Karl-Heinz Loebel

Director, Principal Consultant RegOps Industry/Agency Liaisons, PharmaLex

Akira Yamaguchi

CTO, LORENZ Life Sciences Group

Melissa Rapp

Manager, RegOps, PharmaLex

Jan Wermusch

Product Manager, LORENZ Life Sciences Group

Beginning later this year FDA will reject regulatory submissions that include study data that does not conform to the required standards specified in the FDA Data Standards Catalog.

In this webinar, expernts from PharmaLex and Lorenz will provide:

  • An Overview on the requirements for submitting clinical and nonclinical study data to FDA
  • Details on the specific validation criteria that FDA will use to determie conformance
  • A demonstration of the eValidator tool used to check conformance
  • Specific technical instructions for ensuring successful submission
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