P57: Presentation of Safety Risks Throughout the Product Lifecycle
Poster Presenter
Samuel Ramsden
Head of Risk Management Office
Boehringer Ingelheim International Gmbh Germany
Objectives
1.Compare definitions of safety risks across HA guidelines
2.Apply concepts in presenting risk information in the product lifecycle, with applicable guidelines/regulations, to support patient safety and public health
3.Enable efficient sponsor processes for presenting risk info in product lifecycle
Method
TransCelerate's Interpretation of PV Guidance and Regulations Initiative’s Presentation of Safety Risks Throughout the Lifecycle designed a Framework with an outline of regulatory requirements and considerations for presenting risks in required safety-related regulatory documents in the lifecycle.
Results
This framework was developed in accordance with specific Health Authority (HA) guidance documents applicable throughout the product lifecycle to support safety documents such as Investigator’s Brochure (IB), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER) and Risk Management Plan (RMP). The information was synthesized into a framework to review the key definitions of risk and provide clarity and assist with how to handle presenting risks across the lifecycle in order to meet health authority requirements. Considerations are also provided to assist pharmaceutical companies in developing approaches for the presentation of risk through the lifecycle and across relevant documents. This framework supports a transparent approach to presenting risks and provides a starting point for the collaboration between companies and Health Authorities to protect and improve the health of trial subjects, patients and the public.
Conclusion
From first in human through post-authorization, the regulatory definitions of risks and guidelines related to the presentation of safety information vary across key safety documents and across Health Authorities. The TransCelerate Presentation of Safety Risks Throughout the Lifecycle Topic Team designed a Framework to provide an overview of risk definitions from specific regulatory guidelines and considerations for presenting risks within key safety related regulatory documents which are required at the various product lifecycle stages. This framework was developed in accordance with specific Health Authority (HA) guidance documents applicable throughout the product lifecycle to support safety documents such as Investigator’s Brochure (IB), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER) and Risk Management Plan (RMP). The information was synthesized into a framework to review the key definitions of risk found in the relevant regulatory documents and provide greater clarity and assist with how to handle presenting risks across the lifecycle in order to meet health authority requirements. Considerations are also provided to assist pharmaceutical companies in developing approaches for the presentation of risk through the lifecycle and across relevant regulatory documents. This framework supports a transparent approach to presenting risks and provides a starting point for the collaboration between companies and Health Authorities to protect and improve the health of trial subjects, patients and the public.
