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Bio Waivers

Bio Waivers Date 27 – 28 Febuary 2020, Location – Brussel, Belgium

Course Objectives:

Regulatory agencies have long recognized, that for some drug products, in vivo BA/BE may be self-evident, and, as such, will waive the requirement for in vivo evidence in certain circumstances (grant a biowaiver). The use of biowaivers is in the spirit of avoiding unnecessary human testing whenever possible and facilitate access to drugs. This course will focus on the various biowaivers types, the possibilities opened, but also the limitations. It will highlight the data needed and the way to present them.

Key topics:

  • Biowaiver principles
  • Biowaivers based on solutions
  • BCS based biowaivers
  • Strength biowaivers
  • Locally applied locally acting biowaivers
  • IVIVC based biowaivers
  • Data to support biowaivers
  • Regulatory aspects
  • What to include in the dossier

Training audience :

  • Project Managers
  • Regulatory Senior or Junior
  • Formulation Developers
  • Clinical Managers
  • Agencies Assessors
  • Biowaiver Scientists
  • BA/BE Managers

Registration Fee


€2496


Per Participant


About Brussels

Brussels, officially the Brussels-Capital Region, is a region of Belgium comprising 19 municipalities, including the City of Brussels, which is the capital of Belgium.

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Start Time

9:00 am

February 27, 2020

Finish Time

5:00 pm

February 28, 2020

Address

Brussels, Belgium

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