Presented by
Management Forum
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
11-12 Jan 2022 + 3 more dates
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).
11-12 Jan 2022
Classroom
London venue TBC
00:00-00:00 UK (London)
Course code 11826
Until 07 Dec
4-5 Apr 2022
Live online
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 11620
Until 28 Feb
4-5 Jul 2022
Classroom
London venue TBC
00:00-00:00 UK (London)
Course code 11827
Until 30 May
11-12 Oct 2022
Live online
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
Until 06 Sep
Fully satisfied; even this was managed online, it was great.
Oct 6 2020
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.
Anjali Apte 
Manager, Regulatory Affairs, PharmaLex UK Services Ltd
Oct 6 2020
Globally good presentation, speaker tried to make people participate which is difficult by webinar.
Frédéric LALLEMAND 
Consultant, Lallemand Conseil
UK
France
Switzerland
Belgium
Czech Republic
Denmark
Latvia
Netherlands
Poland
Slovak Republic
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