Understand the specific regulatory & legal environment concerning generic medicinal products. Update your knowledge on regulatory procedures for new applications and variations. Get an overview on the documentation for Generic applications. Understand the current integrated life-cycle approach from development to registration and maintenance, including ICH Q12.
Benefits of attending
how to overcome the specific challenges related to the development and registration of generic medical products in the EU
your knowledge on marketing authorisation procedures
regulatory strategies tailored to your products and your company
an integrated regulatory life-cycle of your products