Clinical Trial Risk Identification, Management and Reporting from Clinical Development to Marketing; Upcoming Webinar Hosted by Xtalks
Retrieved on:
Thursday, October 12, 2023
European, International organization, Medicine, Thermo Fisher Scientific, Safety, Council, ICF, Legislation, Patient safety, International Council, PPD, Clinical trial, Council for International Organizations of Medical Sciences, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Harmonization, Medical device, Pharmacovigilance, EU
TORONTO, Oct. 12, 2023 /PRNewswire-PRWeb/ -- During this webinar, the featured speakers will bring together the various European Union (EU) and United States (US) pharmacovigilance requirements for risk identification, management and reporting, and examine each component sequentially along the drug development journey.
Key Points:
- The featured speakers will discuss the critical interdependencies between signal detection processes, aggregate safety reports, risk management plans, labeling documents and study documents.
- TORONTO, Oct. 12, 2023 /PRNewswire-PRWeb/ -- During this webinar, the featured speakers will bring together the various European Union (EU) and United States (US) pharmacovigilance requirements for risk identification, management and reporting, and examine each component sequentially along the drug development journey.
- From a global perspective, foundational to this are the EU and US regulatory requirements applicable to the clinical trial and post-marketing settings.
- The main elements that will be explored in this webinar include:
1.