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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, the PPD™ clinical research business of Thermo Fisher Scientific

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

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

Learn more about drug safety and pharmacovigilance services.