Presented by
Management Forum
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 (6)"
5-6 March 2024
+ 10-11 July 2024, 1-2 October 2024 »
from £1099
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
5-6 March 2024
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 13447
Until 30 Jan
Not ready to book yet?
for 7 days, no obligation
10-11 July 2024
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 13775
Until 05 Jun
Not ready to book yet?
for 7 days, no obligation
1-2 October 2024
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 13932
Until 27 Aug
Not ready to book yet?
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.
It felt comprehensive.
An excellent resource going forward.
Jul 12 2023
James McCracken
Quality Audit Manager , Advanz Pharma
Jul 12 2023
Webinar was good, informative and lots of information. Speakers are well knowledgeable about Biosimilar Industry.
Srikanth Varma Kc
Global Audit and Due Diligence QA Manager, Abbott
Jul 4 2022
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
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.
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
United Kingdom
Switzerland
Israel
Netherlands
Denmark
France
Belgium
Czech Republic
Germany
Greece
Italy
Latvia
Poland
Slovak Republic
United States of America
2 days
Typical duration
Pricing from:
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 experts Aleksandra Beer and Yesim Nurko 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: