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Course Biosimilars development 2019
Biosimilars
development 2019
2019-03-27 2019-03-27 FLEMING'S Express Hotel Frankfurt Poststraße 8 60329 Frankfurt am Main frankfurt.express@flemings-hotels.com +496927391-0 +496927391-999

Biosimilar Development Workshop

Recent cases in biosimilar clinical development and use will be discussed

This workshop informs you of recent challenges in biosimilar development programmes with regard to quality, clinical and non-clinical issues.
Topics
  • Critical quality attributes
  • Abbreviated study programme: extrapolating indications
  • Similarity testing and interchangeability
  • Biobetter elements and cost-saving supplements
  • Comparability to pre-change product and originator

Aims and objectives

This workshop gives you a thorough update on recent challenges in biosimilar development. Quality, clinical and nonclinical issues will be discussed with reference to recent cases.
It will also provide you with a toolbox for improving your biosimilar development and the ability to position your product.

Who should attend
This workshop addresses the needs of healthcare professionals involved in the development, marketing authorisation and market access of biosimilars. A working knowledge of biosimilar development is a prerequisite.
Your speakers
Dr. Steffen Groß
Paul-Ehrlich-Institut (PEI), Langen

Dr. Bernd Liedert
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim

Dr. Elena Wolff-Holz
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen


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Pharma Webcast Forschung und Produktion

Pharma FORUM Webcast Biologics

We would like to invite you to join our live webcasts, where industry and authority experts will provide you with the latest information on the current challenges in analytics, development, quality and regulatory affairs every month. Most webcasts are specifically focused on CMC while addressing topics at the interface Quality and Regulatory Affairs.

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More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2017 - 09.2018 produced a result of 1.6 (based on a school grading system of 1-6).

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