In this free webinar, gain insights into the need to navigate four main bodies of legislation and guidance (i.e., clinical trial and post-approval requirements in both the European Union and United States) in order to build a comprehensive global risk identification, management and reporting system across the development lifecycle of medicinal products. 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 patient safety perspective, successfully developing and bringing a medicinal product to market requires sponsors and marketing authorization holders (MAHs) to navigate a complex set of interlocking regulatory requirements and expectations. From a global perspective, foundational to this are the EU and US regulatory requirements applicable to the clinical trial and post-marketing settings.
When read together against the context of other international guidance (e.g., from the International Council for Harmonisation and the Council for International Organizations of Medical Sciences), it is possible to chart a complete journey of risk identification, management and reporting through four key bodies of EU/US legislation and associated guidance.
The main elements that will be explored in this webinar include:
1. Clinical development signal detection; approaches; impacts at both a product and study level, including on the investigator's brochure, protocol and informed consent form (ICF)
2. Development safety update report (DSUR)
3. Post-marketing risk management plan (RMP); relationship with core safety information
4. Post-marketing signal detection; approaches; impact on core safety information and country-level labeling
5. Periodic benefit risk evaluation report (PBRER)
Register for this webinar to learn how to successfully develop and maintain the safety profile of medicinal products.
Join David Hillman, Executive Director, Pharmacovigilance; Lyndsey Brawn, Director, Pharmacovigilance; and Tony Stoykova, Director, Pharmacovigilance, from the PPD clinical research business of Thermo Fisher Scientific for the live webinar on Friday, October 27, 2023, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Clinical Trial Risk Identification, Management and Reporting from Clinical Development to Marketing.
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