Regulations relative to pharmaceutical and biopharmaceutical production are constantly evolving and shifting their focus on raw materials and polymeric components and systems used in drug manufacturing processes.
Manufacturing organizations nowadays should not only verify the compliance of their raw materials to the pharmacopoeias of reference but assess and mitigate the risk linked to each element they introduce in the production process as well, including chemicals and polymeric components and systems.
With new markets entering the global drug market, drug manufacturers must adapt such risk assessment to local requirements. China, for instance, represents a huge potential market, but its regulation is often a hard hurdle to overcome.
Manufacturers are thus more and more dependent on the quality and quantity of information their raw material suppliers can provide.
Meet with your peers and industry leaders on September 23rd-24th during our Virtual Regulatory Forum to better understand these regulations and share experiences on how to overcome the challenges they present in cooperation with your raw material suppliers and manufacturing equipment suppliers.
We look forward to meeting you!
AGENDA – DAY 1
10:00 - 10:45 Risk Mitigation and shortened time to market with Emprove® Program (T. Schadendorf)
10:45 - 11:15 Use of Emprove® dossiers data to perform risk assessment according to BioPhorum guidelines (T. Schadendorf)
11:15 - 11:30 Coffee break
11:30 - 12:00 Drug applications in China: Have you considered excipients? (Y. Heinzel)
Following the meeting, Merck’s experts will be available to meet via Zoom breakout sessions.
AGENDA – DAY 2
13:30 - 14:00 Nitrosamine: New Requirements to Evaluate Contamination Risks - View of an API and Excipient Manufacturer (U. Reichert)
14:00 - 14:30 USP <665> - New Requirements for Polymeric Tools in Biopharmaceutical Manufacturing (Simone Biel)
14:30 – 14:45 Coffee Break
14:45 - 15:15 Utilization of BioPhorum Extractable Data to Evaluate the Safety of Final Fill Assembly (Emprove Dossiers for Filtration & Single-Use) (P. Beckett)
15:15 – 15:45 Cell and Gene Therapy – Regulation Overview (M. Aysola)
Following the meeting, Merck’s experts will be available to meet via Zoom breakout sessions.
