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 main elements that will be explored in this webinar include:
- 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.