Marketing Authorisation & Change Procedures for Generics

Understand the specific 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.

Bioequivalence, Dissolution & IVIVC

A unique training course that integrates the in-vitro dissolution testing, pharmacokinetics and biostudies as related to solid dosage formulations.

Advanced IVIVC Professional

A course focused on absorption determination, time scaling, prediction, determination of dissolution limits, case resolution problem from design of studies to final use of IVIVC.