Lecturer: Ralf Hess (M.Sc., PhD) Chief Scientific Officer TPL Path LabsDate: November 14, 2017Time: 17:00-19:00 hLocation: lecture hall, Weismann-Haus, Albertstr. 21A
2015 marked the 50th anniversary of pharmaceutical legislation in the EU, which began with Directive 65/65 in 1965 as a consequence of the Thalidomide disaster (Contergan). The EU legal framework for medicinal products for human use guarantees high standards of quality and safety of medicinal products. To understand the EU legal framework for medicinal products it is important to know the applicable provisions in the regulations itself
Drug development requires following a comprehensive series of regulatory and also statutory requirements and guidance/guideline documents. These documents would be meaningless without the basic legislation which they are built on.
Regulatory frameworks apply throughout the entire product life cycle, from early stage drug development to post market. The underlying GxP quality system frameworks include - but are not limited to - the Good Laboratory Practice (GLP), the Good Clinical Practice (GCP), the Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Pharmacovigilance Practice (GVP). The extent of what frameworks are included in the GxP system often depends on the respective jurisdiction, but GLP, GCP and GMP are always comprised as a minimum.
A short introduction (45 minutes) to the pertinent GxP regulatory framework (GLP/GMP/GCP/GDP) will be given and in additional 45 minutes GxP examples for biologics from early stage drug development to post market will be presented.