戻る Agendas
IMPACT OF THE CLINICAL TRIAL REGULATION ON CMC FILING AND RELEVANT GMP REQUIREMENTS
Session Chair(s)
Anthony Moult
Director Clinical Supplies Operations
Daiichi Sankyo Development, United Kingdom
Sabine Pfister
Sr Compliance Professional
Novartis International AG, Switzerland
The new Clinical Trial Regulation (CTR) will be a key step towards supporting medical research in Europe, covering multiple aspects of the clinical trial, from the organisation, through implementation and the reporting process. The quality of CT material needs to be properly designed and appropriately manufactured. Which quality system should be applied? What are the expectations from regulators at this stage? What consequences for the industry? This session will be a good opportunity, with appropriate timing, to go through it and clarify the legal and regulatory impact (legislation and delegated act) as well as identifying the challenges and opportunities for the pharmaceutical industry.
Speaker(s)
Impact of the CTR on Investigational Product Supply - Potential Challenges for the Industry
Sabine Pfister
Novartis International AG, Switzerland
Sr Compliance Professional