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Safety Risk On-Demand Webinar

Safety Risk Identification, Management and Reporting

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 European Union (EU) and United States (U.S.) regulatory requirements applicable to the clinical trial and post-marketing settings.

  • The various EU and US pharmacovigilance requirements for risk identification, management and reporting, and examine each component sequentially along the drug development journey
  • Clinical development signal detection, approaches and impacts at both a product and study level, including on the investigator’s brochure, protocol and informed consent form (ICF)
  • Development safety update report (DSUR); key considerations and relationship with signal management and the DSUR
  • Post-marketing risk management plan (RMP); relationship with core safety information
  • Post-marketing signal detection, approaches and impact on core safety information and country-level labelling
  • Periodic benefit risk evaluation report (PBRER); key considerations and relationship between the RMP and the PBRER

Speakers:

David Hillman, executive director, pharmacovigilance, PPD clinical research business, Thermo Fisher Scientific

Lyndsey Brawn, director, pharmacovigilance, PPD clinical research business, Thermo Fisher Scientific

Tony Stoykova, director, pharmacovigilance, PPD clinical research business, Thermo Fisher Scientific