A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
★★★★★ "Overall I found this course really helpful and informative. One of the most enjoyable and informati... more"
11-12 Oct 2022
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 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:
The event will be relevant for those working in:
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).
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
11-12 Oct 2022
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11747
Limited places remaining
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for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Overall I found this course really helpful and informative. One of the most enjoyable and informative seminars I have ever attended. Thank you for organizing and a very special thanks to the great speaker!
Jul 4 2022
Regulatory Affairs Officer, Thornton and Ross Ltd
Oct 6 2020
Fully satisfied; even this was managed online, it was great.
Zentiva Group, a.s.
Oct 6 2020
I gained much more understanding than what I had intended to. The trainer also involved everybody in the course and did not make it boring. The topics of non-clinical, clinical, strategy as well as market entry/IP etc were covered briefly too. So that was an added advantage.
Manager, Regulatory Affairs, PharmaLex UK Services Ltd
Oct 6 2020
Globally good presentation, speaker tried to make people participate which is difficult by webinar.
Consultant, Lallemand Conseil
United States of America
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: