Chemistry, Manufacturing & Controls (CMC)

Focus on generics including API, bioequivalence and finished products

Generics are becoming increasingly central in both industrial countries and developing countries. The overall requirements to generics will be detailed including problems in relation to generic substitution and falsified medicines.

The course will consider the important aspects for APIs such as requirements to the production and supplier qualification and certification. The implementation of ICH Q11 will be discussed.

Bioequivalence testing is an integral part of the development of both new medicinal products and generics. Revised EU guidance has been developed and the impact of the new guidance will be thoroughly discussed.

Globalisation is an important element in the production of drug substances and drug products to be licensed and marketed in Europe. This course will focus on three essential topics which are particularly influenced by production in a global environment.

The course will be taught with a combination of presentations by the faculty and work in small groups assisted by faculty members. A significant amount of time will be devoted to working on case studies. Results from the group work will be presented for the full audience on an ongoing basis.