Oral Presentation: Presentation of Safety Risks Throughout the Product Lifecycle

Background/Introduction: From first in human through post-au-thorization, 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 Interpretation of Pharmacovigilance Guidanc...

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Bibliographic Details
Published in:Drug safety 2021-12, Vol.44 (12), p.1399-1400
Main Authors: Semenza, C, Ramsden, S
Format: Article
Language:English
Subjects:
Clarity
Life cycle analysis
Pharmacovigilance
Product life cycle
Product safety
Risk assessment
Risk management
Safety
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Summary:Background/Introduction: From first in human through post-au-thorization, 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 Interpretation of Pharmacovigilance Guidance and Regulations Initiatives Presentation of Safety Risks Throughout the Lifecycle Team designed a Framework with an outline of regulatory requirements and considerations for presenting risks in key required safety related regulatory documents throughout the lifecycle. Objective/Aim: 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. Methods: This framework was developed in accordance with specific Health Authority guidance documents applicable throughout the product lifecycle to support safety related regulatory documents such as safety sections of the Investigators Brochure, Development Safety Update Report, Periodic Safety Update Report/Periodic Benefit-Risk Evaluation Report and Risk Management Plan. Results: The information was synthesized into a framework by the TransCelerate initiative team to review the key definitions of risk and provide clarity and assist with presenting risks across the lifecycle in order to meet health authority requirements. Conclusion: The Presentation of Safety Risks Throughout the Product Lifecycle Framework reviews the key definitions of risk and provide clarity, in addition to assisting with how to handle presenting risks across the lifecycle in line with health authority requirements. An example of the benefits realized by a Sponsor company from leveraging this framework will also be shared.
ISSN:0114-5916
1179-1942