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Management Forum

Biosimilars Training Course

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"

12-13 July 2023
+ 30-31 October 2023
from £1099

Need help? Enrol or reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

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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

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The Biosimilars course will cover:

Day 1
Day 2

Biologics Introduction

Technical and legal definitions
Examples of biologics
The complexity of biologicals
The challenges with development of biologics

Biosimilars vs Generics

How the process is the product
A simple excursive to be reminded of the difference between biosimilars and generics
Creating a copy with limited and imperfect tools

The (e)CTD

International council of harmonization (ICH)
The common technical document
CMC explained (incl. quality by design, specifications)
Why the CMC section for biologics is more extensive (as compared to small molecules)

The (e)CTD Continued

The Registration Process

A review of EMA and FDA biosimilar guidelines
Biosimilar development as a step-wise approach
- Quality
- Non-clinical
- Clinical
Non-comparable biologics
Other regulatory topics
- Interchangeability
- Naming
- Labelling
- Pharmacovigilance

Module 3 for Biosimilars - Section by Section

In-depth review of module 3 documentation with special remarks regarding biologics and biosimilars specifically

Challenges for Biosimilar Sponsors

Global development
Costs
Uncertainty

Main players in the Biosimilar Field

A review of the current situation

Strategic Considerations

A summary of key points to consider when (starting to) develop biosimilars

Case Study

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Marloes van der Geer
Qdossier

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).

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Hans van Bruggen
Qdossier

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.

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Book Biosimilars Live online training

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

12-13 July 2023

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 12247

GBP 1,299
EUR 1,869
USD 2,129

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

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Not ready to book yet?

for 7 days, no obligation

30-31 October 2023

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
05:00-13:00 New York (UTC-04)
Course code 12367

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 25 Sep

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

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.

Reviews of IPI's Biosimilars training course

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!

Jul 4 2022

Deepthi Vanavasam United Kingdom
Regulatory Affairs Officer, Thornton and Ross Ltd

Oct 6 2020

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

Czech Republic
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 United Kingdom
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 France
Consultant, Lallemand Conseil