Presented by
Management Forum
Biosimilars Training Course
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
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
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.
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?
This course is perfect for pharmaceutical professionals working in regulation, quality assurance, pharmaceutical development, and R&D, including:
- Regulatory affairs professionals
- Medical affairs professionals
- Clinical development managers
- Quality assurance personnel
- Legal and compliance officers
Andrew Willis
San Salvatore Training Ltd
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:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
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
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 26 Dec
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 16 Apr
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 26 Aug
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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.
Reviews of IPI's Biosimilars training course
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
- Advanz Pharma
- Advanz Pharma Services (UK) Limited
- Gilead Sciences
- ipsen
- PharmaLex UK Services
- PharmaLex UK Services Ltd
- Phibro Animal Health
- Subiaco Associates Ltd
- Thornton & Ross Ltd.
- Thornton and Ross Ltd
Switzerland
- Abbott Products Operations AG
- Celonic
- ExcellGene
- Mylan Pharma GmbH
- Sochinn Consulting
France
- Lallemand Conseil
- MERCK BIODEVELOPMENT
- syneos health
Israel
- unipharm
- Unipharm Limited
- Unipharm Ltd
Latvia
- AS Kalceks
- JSC Olainfarm
- Olainfarm AS
Netherlands
- Abbott
- Abbott Healthcare Products B.V
- Qdossier
Denmark
- Novo Nordisk A/S
- PharmaIT
Germany
- Boehringer Ingelheim Vetmedica GmbH
- Fresenius SE & Co. KGaA
Australia
- Elanco
Belgium
- UCB Biopharma
Czech Republic
- Zentiva Group, a.s.
Greece
- Pharmathen SA
Italy
- Abbott
Poland
- Sieć Badawcza Łukasiewicz
Portugal
- Generis Farmacêutica S.A.
Slovak Republic
- Ewopharma International, s.r.o.
Spain
- LABORATORIO REIG JOFRE, S.A.
United States of America
- Biogen
Run Biosimilars Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
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:
