Yahoo Finance 2 Day Biosimilars Training Course: Global Overview of Biosimilars and how they Differ from the Original Biological Product (October 11-12, 2022)
Dublin, Sept. 28, 2022 (GLOBE NEWSWIRE) -- The "Biosimilars Training Course" conference has been added to ResearchAndMarkets.com's offering.
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.
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.
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 Registration Process
Module 3 for Biosimilars - Section by Section
Challenges for Biosimilar Sponsors
Main players in the Biosimilar Field
Strategic Considerations
Case Study
Key Topics Covered:
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/u5dbwf
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