Last Chance to Register for This Biosimilars Training Course: Covering the Regulatory Pathways and Challenges for Both the EU and US (October 11-12, 2022) – ResearchAndMarkets.com

Last Chance to Register for This Biosimilars Training Course: Covering the Regulatory Pathways and Challenges for Both the EU and US (October 11-12, 2022) – ResearchAndMarkets.com




Last Chance to Register for This Biosimilars Training Course: Covering the Regulatory Pathways and Challenges for Both the EU and US (October 11-12, 2022) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Biosimilars Training Course” conference has been added to ResearchAndMarkets.com’s offering.

With some of the world’s best-known biologics continuing to face patent expiration in the coming years, the biosimilar market is set for continued growth.

This seminar will provide you with a global overview of biosimilars and how they differ from the original biological product. The programme will discuss the unique considerations of biosimilars as compared with small molecule generics.

Our expert trainer will cover the regulatory pathways and challenges for both the EU and US for biosimilars, and explore the key dossier requirements for biotech products compared to pharma products. Strategies for the development of biosimilar products will also be discussed and you will be introduced to key biological requirements and the concept of totality for biological review.

Benefits of attending:

  • Discuss global considerations and definitions of biotech/biosimilar products
  • Gain an invaluable overview of the regulatory pathways for biosimilars in the EU and US
  • Understand the key Module 3 dossier requirements for biotech products versus pharmaceutical products
  • Learn how to develop effective strategies for the development of biosimilar products

Who Should Attend:

The event will be relevant for those working in:

  • Regulatory
  • Quality assurance
  • Pharmaceutical development
  • R&D

Key Topics Covered:

  • Biologics Introduction
  • Biosimilars vs Generics
  • The (e)CTD
  • The (e)CTD Continued
  • The Registration Process
  • Module 3 for Biosimilars – Section by Section
  • Challenges for Biosimilar Sponsors
  • Main players in the Biosimilar Field
  • Strategic Considerations
  • Case Study

Speakers

Hans van Bruggen

Qdossier

Hans van Bruggen is CEO of and Senior Regulatory Affairs Scientist at Qdossier. He holds an MSc. in Pharmaceutical Medicine from the University of Surrey (UK) and has worked in the pharmaceutical industry for more than 35 years, primarily at global or European headquarters sites. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of drugs for patients and healthy volunteers. He approaches interdisciplinary and international processes using that scientific background. He applies new technologies and Artificial Intelligence to facilitate the business and let people focus on what they can do best.

Marloes van der Geer

Senior Regulatory Affairs Scientist

Qdossier

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier. Marloes’ areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).

For more information about this conference visit https://www.researchandmarkets.com/r/tv2dp1

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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