This 3-day training course focuses on the highly important contribution of biopharmaceuticals to new drug development. As the functions of biopharmaceuticals are fully explored and utilised, they will become increasingly relevant to the drug development community.
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 of 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 Chemistry, Manufacturing and Controls (CMC) section, comparability packages, and the important safety procedures required for infectious agents.
The particular aspects of 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 mono-clonal 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.
What You Will Learn
Definition and characteristics of biopharmaceuticals
Topics of particular relevance to biopharmaceuticals such as comparability, immunogenicity, adventitious safety, bioassays
Biosimilar medicinal products
Modules 3, 4 and 5 of the EU Common Technical Document (CTD) of biopharmaceuticals
Regulatory pathways for scientific advice, clinical trials and marketing authorisations of biopharmaceuticals
Who Should Attend
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.
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
Hotel & Travel
The DIA has blocked a limited number of rooms at the following hotel:
Dorint Hotel an der Messe
Tel.: +41 61 695 7000
Fax: +41 61 695 7100
at the rate of:
CHF 230.00 per room inclusive of breakfast, service charge and VAT, exclusive of city tax of CHF 3.50 per day.
To make your reservation, please use this booking form.
Cancellations of reservations are possible until +31 days prior to arrival.
Important: Please complete your reservation by 19 August 2013. Reservations received after this date will be subject to hotel availability and room rate may vary.
Kuechengasse 16, Postfach
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52