Presented by
Management Forum
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
★★★★★ "Content was informative, I've learned many new details and subjects to consider. Speaker was fluent ... more (8)"
30-31 January 2025
+ 21-22 May 2025, 30 September-1 October 2025 »
from £1099
Prepare for the biosimilar market growth as some of the world’s best-known biologics face patent expiration in the coming years.
In today's pharmaceutical landscape, the rise of biosimilars presents a pivotal shift in therapeutic options, offering more affordable alternatives to biologics whose patents are expiring. With major biologics facing patent expiration in the near future, the biosimilars market is poised for substantial growth, driving increased interest and investment in this sector.
This seminar delves into the critical distinctions between biosimilars and their reference biologics, addressing the complex regulatory pathways and challenges in both the EU and US markets.
Participants will gain insights into essential dossier requirements specific to biotech products compared to pharma products, alongside strategies for successful biosimilar development. Moreover, the course emphasises key biological considerations and the concept of totality in biological reviews, discussing unique aspects of biosimilars compared to small molecule generics.
This course will equip attendees with comprehensive knowledge essential for navigating the evolving biosimilar landscape.
This course is part of our Biopharma training courses series which aims to provide up-to-date knowledge on industry best practices and regulations surrounding biopharmaceuticals.
This course is perfect for pharmaceutical professionals working in regulation, quality assurance, pharmaceutical development, and R&D, including:
Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.
He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.
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
30-31 January 2025
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 14545
Until 26 Dec
Not ready to book yet?
for 7 days, no obligation
21-22 May 2025
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 14817
Until 16 Apr
Not ready to book yet?
for 7 days, no obligation
30 September-1 October 2025
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 14958
Until 26 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; and apply only when booking multiple delegates on the same date.
Content was informative, I've learned many new details and subjects to consider. Speaker was fluent and interactive. I'll recommend this course to new QP's in the future.
Mar 5 2024
Lian Abu-Obed
QP Trainee, Unipharm Limited
Mar 5 2024
I wanted to get short insight into biosimilar development process and I completely accomplished it.
Ainars Gavarans
Olainfarm AS
Jul 12 2023
It felt comprehensive. An excellent resource going forward.
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
France
Israel
Latvia
Netherlands
Denmark
Australia
Belgium
Czech Republic
Germany
Greece
Italy
Poland
Portugal
Slovak Republic
Spain
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: