Informa
Showing of Streams
09:00 - 17:00 480 mins
Pre-Conference Workshop #1: Preparing for an FDA Inspection
Pre-Conference Symposium #1: Preparing for an FDA Inspection
  • Scott Wheelwright, PhD - Co-Founder, Complya Asia Co., Ltd.
09:00 - 17:00 480 mins
Info
Pre-Conference Workshop #2: The Essentials of Technology Transfer
Pre-Conference Symposium #2: The Essentials of Technology Transfer
  • Instructor Richard Dennett - Senior Director Regulatory Affairs CMC, PPD

Virtually every company will need to outsource certain factors over the course of its drug product development; whether it be analytical and process development, cGMP contract manufacture, characterization and viral clearance testing, validation, regulatory support etc.  This is underpinned by Technology Transfer.

Principal junctures of Technology Transfer can occur between pre-clinical to first into human (FIH), successive clinical stages and through to commercial manufacture.

Technology transfer elements can be complex and in today's fast-moving field of drug development there can be no room for error, with associated cost and delay implications. Technology transfer lies directly on the critical path and therefore must be right 'first time'. Demonstration of Product Comparability forms an essential element of certain technology transfer situations and which is essential in ensuring an exacting clinical product and meeting regulatory expectation.

In this workshop we will examine essential technology transfer as it applies to multiple product types (recombinants, biologics, vaccines, cellular and gene therapy products, conjugates etc.) and

  • The nature of the challenge
  • Strategy
  • The 'nuts and' bolts of technology transfer
  • Application to different product types recombinants, mAbs, biologics, ATMPs, biosimilars etc.
  • Considerations of early and late stage transfers
  • Pre-clinical to FIH
  • cGMP manufacture
  • The importance of the quality target product profile
  • Ensuring Product Comparability
  • Change control
  • Regulatory compliance and health authority expectation
  • Managing risk
  • Sourcing and selection of a CMO partner
  • Project management
  • Technical and Quality agreements, protocols and reports
  • Dealing with issues and how to get things back on track
  • In licensing
  • Commercial strategy
  • Common pitfalls

The workshop will incorporate a mix of interactive modules, real life case studies, key topic points for discussion plus will provide model examples of actual technical quality agreements, technology transfer protocols and reports.

Instructor: Richard Dennett, Senior Director Regulatory Affairs CMC, PPD, France 

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