BioPharmaChem Ireland (BPCI)
CMC Regulatory Affairs Training Course
Dates: Tuesday 24th September 2024 (8.30 am – 5pm)
Wednesday 25th September 2024 (8.30am – 3.30pm)
Location: Radisson BLU Hotel & Spa Limerick, Ennis Road, Limerick V94 YA2R
BioPharmaChem Ireland (BPCI) is delighted to announce the return of its biennial Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs training course that will take place in-person at the Radisson BLU Hotel & Spa Limerick over two days on Tuesday 24th and Wednesday 25th September 2024. This training course has been run by BPCI for its members for over a decade.
This year’s CMC Regulatory Affairs Training Course will centre its discussions on the key European (EU) and United States (US) Regulatory Affairs related to pharmaceutical drug manufacturing and supply including a focus on the key areas of External Manufacturing and Global Supply Chain Regulatory issues. It will delve into the significance of simplifying complexity and discerning the essential priorities of the pharmaceutical drug regulatory landscape across the submission of applications to Regulatory Authorities.
This enhanced understanding can lead to shorter approval times. By streamlining regulatory processes, aligning initiatives with strategic objectives, and maintaining a focus on pre- and post-approval regulatory matters, participants can position themselves as strategic partners who drive value and contribute to the long-term success of the organisation. It is targeted at individuals employed in the pharmaceutical drug manufacturing sector.
Additionally, participants will have the opportunity to interact with regulatory professionals and Health Product Regulatory Authority (HPRA) representative(s) in person, enhancing their knowledge of pharmaceutical regulatory affairs.