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Meet the training leader

  • Jean-Michel Cardot
  • Professor
  • Clermont-Auvergne University, France

Course description

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

Locally applied locally acting biowaivers

IVIVC based biowaivers

Data to support biowaivers

Regulatory aspects

What to include in the dossier

Special Features

Interactive learning approaches

Individual case by case consultancy with the trainer

Comprehensive printed and digital course documentation

5H+ of networking with other industry experts

Case studies from the trainer's experience 

Certificate of completion issued by the trainer

Key Takeaways

Recognize when to use a biowaiver approach?

Analyse the available data and the chance of success

Learn how to construct a biowaiver dossier

Understand the various data needed and the key issues for biowaivers

Evaluate & optimise the biowaiver strategy in connection with product development

Join us in Prague

It’s home to the largest castle in the world. Dating back to the ninth century, Prague Castle spans an impressive 18 acres and is home to stunning cathedrals, chapels, royal palaces and gorgeous ornamental gardens

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Save 300 Eur with promo code 300SEASONAL9, valid until 20 December 2019

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