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Biosimilars Training Course

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

11-12 Oct 2022

Book or reserve now

Details

Course overview

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:

  • 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 development of biosimilar products

Who should attend?

The event will be relevant for those working in:

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

Presenter

Marloes van der Geer (More...)

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).

Book now

Book or reserve now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
30% off the 2nd delegate; 40% off the 3rd delegate; 50% off the 4th delegate

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
11-12 Oct 2022
Live webinar
09:00-17:00
UK (London)
11-12 Oct 2022
Live webinar
09:00-17:00
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 6 Sep*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • AS Kalceks
  • Boehringer Ingelheim Vetmedica GmbH
  • Ewopharma International, s.r.o.
  • Gilead Sciences
  • ipsen
  • Lallemand Conseil
  • Mylan Pharma GmbH
  • PharmaIT
  • PharmaLex UK Services Ltd
  • Qdossier
  • Sieć Badawcza Łukasiewicz
  • Sochinn Consulting
  • Subiaco Associates Ltd
  • syneos health
  • Thornton and Ross Ltd
  • UCB Biopharma
  • Zentiva Group, a.s.

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!

Deepthi Vanavasam, Regulatory Affairs Officer, Thornton and Ross Ltd, Jul 22

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 20

Globally good presentation, speaker tried to make people participate which is difficult by webinar.

Frédéric LALLEMAND, Consultant, Lallemand Conseil, Oct 20

Fully satisfied; even this was managed online, it was great.

, Zentiva Group, a.s., Oct 20