The International Council for Harmonisation (ICH) has announced that the ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reached Step 2 of the ICH process on 20 December 2022.

While regional public consultations on the draft text take place, Medicines for Europe will gather leading international experts at the 2nd Workshop on Bioequivalence, which is scheduled to take place on 26 April 2023, as a face-to-face event, at THE HOTEL in Brussels, Belgium.

The workshop will provide a platform for an exchange of views between industry, regulators and academia and will cover the following topics:

  • International convergence and reliance
  • ICH M13
  • Model informed drug development and virtual BE
  • Implementation of M10 from the European perspective
  • Compliance and oversight in BE

The detailed agenda and registration page will be available soon.

Join us in Brussels in these very special times for Bioequivalence and participate in the lively discussions!

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