Training Course on Authorisation of Biopharmaceuticals, Biosimilars and Advanced Therapies in Europe Course

Date(s) And Time(s):
May 4 2011 9:00AM - May 6 2011 5:00PM



The course will provide insight into the data requirements for the Common Technical Dossier (CTD) and the Investigational Medicinal Product Dossier (IMPD) writing. Case studies on a monocional antibody will illustrate the approach taken the identify the benefit/risk ratio and a case study discussing how to develop a protein, with lack of the relevant animal model, will also be examined. The most essential issues of advanced therapies and biosimilars product classes, which is part of the EU provisions related to biopharmaceuticals, will be outlined in the course.

Featured Topics Include

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

Learning Objectives:

Apply the complex nature of biopharmaceuticals compared to conventional pharmaceutical product in regulatory submissions
Describe the key quality issues specific to biopharmaceuticals and apply them in 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 part of submissions of biopharmaceuticals
Explain the particulars of, and the data requirements specific to, the main product classes of biopharmaceuticals, ATMPs and biosimilars
Learn to prepare CTA and MAA submissions for biopharmaceuticals in Europe

Target Audience:

Regulatory affairs and clinical research professionals who wish to orientate their career towards biopharmaceuticals or who wish to update their existing knowledge.
Level: Junior/Intermediate level regulatory affairs professionals

Event Code:

Contact Information:
DIA Europe


PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52