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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.

★★★★★ "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

Need help?  Enrol or reserve

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 

Enrol or reserve

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.

More details

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

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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

View basket 

 
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

View basket 

 
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

Australia

  • Elanco

Belgium

  • UCB Biopharma

Czech Republic

  • Zentiva Group, a.s.

Germany

  • Boehringer Ingelheim Vetmedica GmbH

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

Enrol or reserve

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:

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:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy