Authorization of Biopharmaceuticals, Biosimilars, and Advanced Therapies in Europe
Venue: Hotel Bildungszentrum 21
|Event Date/Time: May 21, 2012||End Date/Time: May 23, 2012|
Serious estimates suggest that 30% to 50% of newly authorised medicinal products are biopharmaceutical in nature. Biopharmaceuticals stem from a biological source with their protein structure transcribed from genetic information and expressed by a living cell. They are usually large and complex and their quality is determined by the manufacturing process where consistency and stability are extremely important. Biopharmaceuticals are pleiotropic and immunogenic and their non-clinical pharmacodynamic and safety characterisation is often hampered by lack of relevant animal models. Advanced Therapy Medicinal Products (ATMPs) are examples of innovative technologies used to develop and manufacture biopharmaceuticals. All these factors have implications for the way biopharmaceuticals are developed and regulated. European pharmaceutical legislation contains regulations specific to biopharmaceuticals and these will be covered in this course.
The course introduction provides an overview of both classical and biotechnology derived medicinal products and on the pathways used for scientific advice, clinical trials and marketing authorisations in Europe. The course will also cover in detail the particular requirements for the CMC section, comparability packages, and the important safety procedures required for infectious agents.
The particular aspects of the non-clinical and clinical development of biopharmaceuticals will be presented. A case study discussing how to develop a protein, without the relevant animal model, will also be examined. Case studies on monoclonal antibodies will illustrate the approach taken to identify benefit/risk ratio. An overview will be given on the most essential issues relating to ATMPs. A detailed presentation of the specific considerations for the development of biosimilar medicinal products, part of the EU provisions related to biopharmaceuticals, will be given during the course.
Definition and characteristics of biopharmaceuticals
Topics of particular relevance to biopharmaceuticals such as comparability, immunogenicity, adventitious safety, bioassay
Biosimilar medicinal products
Modules 3, 4 and 5 of the EU CTD of biopharmaceuticals
Regulatory pathways for scientific advice, clinical trials and marketing authorisations of biopharmaceuticals
At the conclusion of this training course, participants should be able to:
Identify the relevant stakeholders and pathways for regulatory submissions in the EU
Describe the unique approach required to develop and to authorise complex biopharmaceuticals, compared to conventional pharmaceutical products
Describe the key quality issues specific to biopharmaceuticals and apply them to the regulatory process
Identify the implications of changes in the manufacturing process on the quality of the product
Identify the relevant documentation for the non-clinical and clinical parts of submissions of biopharmaceuticals
Explain the particulars of, and the data requirements specific to, the main product classes of biopharmaceuticals, ATMPs and biosimilars
Understand common flaws in regulatory submissions and best practices relevant for European submissions
Regulatory affairs and clinical research professionals who wish to focus their career on biopharmaceuticals or who wish to update their existing knowledge.
This course is particularly relevant to junior and intermediate level regulatory affairs professionals.