Biosimilars Training Course
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Details
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
Programme
Global considerations and definitions of biotech/biosimilar products
- What is a biologic and legal definitions
- What makes biological molecules different to small molecules?
- Product equals the process – what does this mean?
- What is a biosimilar – the layman versus the legal definition
- Review small molecule versus biotech
Registration of biosimilars
- EMA/FDA attitude towards biosimilars, safety/efficacy/quality, clinical and non-clinical evaluation, PK/PD study, immunogenicity, extrapolation, PV, prescription information
- Regulatory procedures for approval in EU and US
- Regulators/company perspectives on interchangeability and switching
- Potential strategic impact to development for interchangeability claim
Understanding the key dossier requirements for biotech products versus pharma products – Module 3
- Comparability versus similarity data
- How to decide if further clinical studies are required
- What further testing is required?
- Type and design of studies – indication studies, multiple indications, bridging studies, biomarkers, PK limits, safety
- Non-clinical considerations
- How to address immunogenicity and how to use the information
- Clinical considerations
- Detailed review of Module 3 sections for CTD 3.2.S and 3.2.P
- Understand QbD for biotech products
Review of Modules 4 and 5
- EU/US examples of clinical and non-clinical developments
- Key concepts of clinical comparability and totality of similarity
Analysing the regulations and impact on the following procedures
- Marketing applications
- Clinical trial applications
- Review procedures
Developing effective strategies/understanding for review and development of biosimilar products
- Similarity versus comparability
Further considerations for IP, Perceptions, Market Entry, Cost/Time, Project Management
Presenter
Marloes van der Geer (More...)
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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11-12 Jan 2022 Face-to-face, (venue not yet confirmed) |
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11-12 Jan 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 7 Dec* |
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to attend Face-to-face (venue not yet confirmed) |
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4-5 Apr 2022 Live webinar |
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4-5 Apr 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 28 Feb 22* |
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to attend Live webinar |
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4-5 Jul 2022 Face-to-face, (venue not yet confirmed) |
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4-5 Jul 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 30 May 22* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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11-12 Oct 2022 Live webinar |
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11-12 Oct 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 6 Sep 22* |
Enrol now
to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code