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 Harmoisation (ICH) and the CIOMS – 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 are as follows:
- 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)
- Development safety update report (DSUR)
- Post-marketing risk management plan (RMP); relationship with core safety information
- Post-marketing signal detection; approaches; impact on core safety information and country-level labelling
- Periodic benefit risk evaluation report (PBRER)
They will also discuss additional considerations for the period in which a medicinal product is authorized for marketing and still undergoing clinical development (i.e., the impact of new clinical trial safety data on post-marketing documents and; the impact of new post-marketing data on clinical trial documents).
In conclusion, they will provide a high-level re-cap of the different document and process interdependencies covered and how these ultimately bind together into a comprehensive product risk identification, management and reporting system.
Register for this webinar to learn how to successfully develop and maintain the safety profile of medicinal products.
David Hillman, Executive Director Pharmacovigilance, PPD clinical research business, Thermo Fisher Scientific
David Hillman joined the business in 2010, having previously worked in various drug safety roles within the pharmaceutical industry. After several years of overseeing case processing teams and leading the rebuilding of the global safety reporting function, David turned his attention to developing our specialized PV capabilities.
Today our scientific & integrated services group consists of 50 talented medical scientists and healthcare professionals from 15 countries; together they provide all clinical trial and post-approval safety writing (aggregate reports, risk management plans), safety science (including signal detection), literature surveillance, QPPV and local PV services. David has worked in drug safety for over 18 years and holds a PhD in Pharmacology from University College London (UCL).
Lyndsey Brawn, Director Pharmacovigilance, PPD clinical research business, Thermo Fisher Scientific
Lyndsey Brawn joined the business in 2012 and has broad experience in performing and managing a wide range of pharmacovigilance activities in both clinical trials and post-approval settings. For the past eight years, Lyndsey has led our dedicated safety writing group which, spread across ten countries, is responsible for all DSUR, PBRER, PA[D]ER and RMP authoring. More recently she has also taken on oversight of our global literature surveillance group. Lyndsey has worked in the field of drug safety for over 14 years and holds a PhD in Cellular Microbiology from the University of Cambridge.
Tony Stoykova, Director Pharmacovigilance, PPD clinical research business, Thermo Fisher Scientific
Tony Stoykova has more than 11 years of experience across clinical trial and post marketing pharmacovigilance, including both operational and project management activities. In her current role, she leads our pharmacovigilance safety science group, responsible for all signal detection/management services and related activities (e.g., safety labelling support and responses to regulatory authority safety enquiries).
Additionally, she oversees EU/UK Qualified Person for Pharmacovigilance (QPPV) service alongside a range of specialized PV tasks, such as PSMF and PVA authoring/maintenance, and local pharmacovigilance activities. Tony holds an MD degree from the Medical University of Sofia in Bulgaria.
Who Should Attend?
This webinar will appeal to professionals (management or individual contributors) with responsibilities relating to the human safety of developmental or market-authorised medicinal products (inclusive of biologicals), particularly those responsible for signal detection, DSURs, RMPs, PBRERs or core safety information management in the following fields:
- Regulatory affairs
- Clinical development
What You Will Learn
Attendees will 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 (EU) and United States (US) in order to build a comprehensive global risk identification, management and reporting system across the development lifecycle of medicinal products
- The critical interdependencies between signal detection processes, aggregate safety reports, risk management plans, labelling documents and study documents
- Understanding and managing these interdependencies to avoid unnecessary adverse regulatory authority scrutiny and legal risk. Discrepancies need to be avoided wherever possible and well documented where legitimate
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, PPD‘s capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, we serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, we apply cutting-edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.