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PharmaFORUM | Webcast Biologics

March 30, 2023

Join biotech experts in this FORUM institut webcast series that will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

Asphalion’s expert, Dr Chris Mann will deliver one on “First-in-human (FIH) clinical trial applications and INDs for ATMPs: special considerations” on May 17, 2023, at 14:00 CET.

The session will cover:

  • Structure and timing of the application(s): tricks and tips to simplify
  • Interface between the IB and other parts of the dossier and what to include and what not to include
  • Special documents, such as pharmacy Manual, Surgery Manual
  • Special considerations, such as HTA involvement, GMO licenses, potency assays, long-term follow-up (LTFU)

Do not miss it!

Other coming Webcasts include:

  • Filing for a BLA vs MAA application with focus on the CMC requirements
  • Advantages and disadvantages of different approval procedures (MRP/DCP/CP)
  • CMC requirements for Gene Therapy Medicinal Products: US and EU jurisdiction


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