TGA Regulatory Reforms (T4)

Speaker/s

  • Dr Harry Rothenfluh, Head, Office of Medicines Authorisation, TGA

Chair

  • Helen Critchley, Head of Regulatory Affairs and Product Safety, Sanofi-Aventis

Synopsis

Dr Harry Rothenfluh will provide an update on the TGA’s Business Process Reforms (BPR) for prescription medicines, and also an overview of the proposed next steps for implementing BPR for over-the-counter medicines.

Two other TGA speakers (TBC) will outline other developments in regulatory reforms throughout the TGA, including an update on the progress of the Transparency Review.

Learning Objectives:

  • Business Process Reforms
  • Transparency Reviews

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