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Sem. 4.1: Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier & 4.2: Non-clinical and clinical development of biopharmaceuticals including biosimilars and the Module 4 and 5 requirements


Course Description

Seminar 4.1 (first part, in January) - PHARMACEUTICAL DEVELOPMENT OF BIOPHARMACEUTICALS AND PARTICULARS OF THE CMC DOSSIER

CONTENT

Biopharmaceuticals are special since they stem from a biological source, or the protein structure is transcribed from genetic information and is expressed by a living cell. They are usually complex and large and the quality is determined by the manufacturing process, where consistency and stability need particular attention. This has implications on the way biopharmaceuticals are developed and regulated and particular guidelines are available which are covered in this seminar. The manufacturing process determines the quality of these products and the requirements for the key quality (CMC) issues are complex accordingly. Issues specific to biopharmaceuticals such as the manufacturing process definition, consistency, stability, definition of specifications, infectious agents' safety, comparability, bioassay are covered in this seminar as well as specific topics such as how changes of the process can impact the quality of these products. In addition to the European requirements on biopharmaceuticals the specific requirements of other global regions are dealt with in detail. Furthermore, the specific requirements for IMPs, investigational medicinal products are covered.

TOPICS COVERED

- Sources and main characteristics of biopharmaceuticals
- European CMC data requirements for the marketing authorization (Module 3) and for the IMP
- Comparability
- Formulation development
- Isoform characterization and glycosylation of biopharmaceuticals
- Virus and TSE safety
- Stability of biopharmaceuticals
- Bioassay establishment and data presentation
- New approaches in the manufacture - platform technologies and QbD
- CMC Data requirements in the USA and Japan
- The special characteristics of the International Nonproprietary Name system (INN) for biopharmaceuticals

LEARNING OBJECTIVES

- Understand the key quality (CMC) issues specific to biopharmaceuticals such as the manufacturing process definition, consistency, stability, definition of specifications, infectious agents' safety, comparability, bioassay use and apply them in the regulatory strategy
- Understand and adapt the implications of the introduction of changes in the manufacturing process on the quality of the product, i.e. apply the comparability concept
- Allows to conduct and steer the relevant regulatory strategy for CTA and MAA submissions for biopharmaceuticals due to knowing the rules and required data for Module 3
- Understand the CMC essentials of an IMPD/CTA, CTD and MAA submission
- Understand the regional differences in the scientific requirements for regulatory submissions for biopharmaceuticals and to utilize this in global submissions

Seminar 4.2 (second part, in March): NON-CLINICAL AND CLINICAL DEVELOPMENT OF BIOPHARMACEUTICALS INCLUDING BIOSIMILARS AND THE MODULE 4 AND 5 REQUIREMENTS

CONTENT

Biopharmaceuticals play an important role in the pharmaceutical industry since they deliver an increasing number of candidates for new product developments. They are however special and require certain considerations in their pre-clinical and clinical development. They are pleiotrop and immunogenic and their non-clinical pharmacodynamic and safety characterisation is often hampered by insufficiently relevant animal models. Biosimilars are developed following a special regulation and expanded programme as compared to conventional generics. This all has implications on the way biopharmaceuticals are developed and regulated. The particulars of the non-clinical and clinical requirements of biopharmaceuticals are covered and the specific considerations on the development of biosimilar medicinal products are part of this seminar as well. In this seminar case studies will also be presented on successfully authorized products, such as on a tri-functional monoclonal antibody and on a biosimilar. The seminar also introduces how to perform a benefit-risk assessment at the authorization stage and how to update it during life-cycle of the product.

TOPICS COVERED

- Principles of non-clinical development
- Principles of clinical development
- Immunogenicity
- Case studies on monoclonal antibodies, erythropoietin and a biosimilar
- Case presentation on the tri-functional monoclonal antibody Catumaxomab
- Development and registration of biosimilars

LEARNING OBJECTIVES
- Understand the specific challenges in the pre-clinical development of biopharmaceuticals
- Understand the essential clinical development approach
- Learn to assess the benefit-risk ratio during the whole life cycle of a product
- Understand the data requirements specific to biosimilars
- Learn why immunogenicity is a typical issue for biopharmaceuticals and how it is investigated and handled appropriately
- Allows to conduct and steer the relevant regulatory strategy for CTA and MAA submissions for biopharmaceuticals due to knowing the rules and required data for Modules 4 and 5 of biopharmaceuticals

Entry Requirements

English language knowledge

Course Fees

2.800 EUR regular fee, 1.720 EUR for academic institutions/government (+19% German VAT)/seminar


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Recipient: European Centre of Regulatory Affairs, EUCRAF

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