OVERVIEW

British Pharmacological Society (BPS) Launching a New Medicine (Training Workshop) is organized by British Pharmacological Society (BPS) and will be held on Oct 26, 2023.

Overview:
The workshop is newly developed and is geared towards a wide audience from pharmacologists to drug discovery scientists to regulators. It provides an introduction to the subject and goes further and so it is suitable for those new to the topic, as well as more experiences professionals.

Topics:
• Non-clinical evidence
• Evidence needed for regulatory approval and decision making boards for new medicine filing
• Clinical Trial Authorisation (CTA) submission
• Investigators brochure - core content and aim
• Investigational Medical Procurement Dossier (IMPD)
• Gaps in data – approached with a holistic view
• Medicines and Healthcare products Regulatory Agency (MHRA) perspective – when can clinical trials start
• Evidence base (non-clinical TOC, Pharmacokinetics (PK), translational medicine, 'Chemistry, Manufacturing, and Controls' (CMC)) – do these four combine to demonstrate success in humans?
• Market Authorisation Application (MAA)
• European Medicines Agency (EMA) and MHRA Assessors
• How and why all information needs to be on the label, both good and bad