The Masterclass is intended to help you dive deep into the design and execution of the major CMC analytical studies. This will be opened by an overview of maintaining regulatory compliance for marketed drug products along with a special focus on how new and upcoming guidelines will impact your businesses. Important activities to ensure regulatory compliance and how approvable specifications for API's and finished products be drafted will be discussed, along with additional sessions on how facing tough challenges in CMC dossier preparation, followed by a discussion on how quality risk management according to ICH Q9 should support product lifecycle from baseline CMC to variations and much more.
This is a live, two-day masterclass limited to a selected set of participants across Europe & UK and will be conducted by seasoned regulatory affairs expert and lecturer, Dr. Helmut Vigenschow who holds more than 30 years of experience in the Pharmaceutical sector.
An exclusive discount of 20% is available for RSC members valid until 31/01/2021
This is a live, two-day masterclass limited to a selected set of participants across Europe & UK and will be conducted by seasoned regulatory affairs expert and lecturer, Dr. Helmut Vigenschow who holds more than 30 years of experience in the Pharmaceutical sector.
An exclusive discount of 20% is available for RSC members valid until 31/01/2021
