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Wednesday, June 15 • 2:00pm - 5:00pm
33P: Presentation of Safety Risks Throughout the Product Lifecycle Framework: Key Findings and Practical Uses

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Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-22-507-L04-P ; CME 2.75; IACET 2.75; RN 2.75

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The TransCelerate “Interpretation of Pharmacovigilance Guidances and Regulations” (IGR PV) Initiative designed a framework (entitled “A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle”) outlining regulatory requirements and considerations for presenting risks in key required safety-related regulatory documents throughout the lifecycle.

This framework was developed based on 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)
  • Risk Management Plan (RMP)

The information was synthesized into a framework to review the key definitions of risk, provide clarity, and assist with how to handle presenting risks across the lifecycle to meet health authority requirements. Considerations are also offered to help pharmaceutical companies develop approaches for presenting risk through the lifecycle and across relevant safety documents, given differing regulatory requirements over a product’s lifecycle. This framework supports a transparent approach to presenting risks and provides a starting point for collaboration between industry and health authorities to protect and improve the health of trial subjects, patients, and the public.

This session will share key findings that the framework synthesized and discuss practical use cases, such as how it can be used to upskill and educate safety professionals within biopharma organizations. By leveraging this framework, participants will be able to incorporate these key findings and considerations into their organizations and better operationalize the presentation of safety information in key documents.

Registration Info Rate: $350
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Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides

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Who should attend?

Professionals in the fields of Pharmacovigilance and drug safety including risk management, periodic reports, therapeutic area safety, signal management, QPPV, etc. as well as clinical development and regulatory.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Explain the framework’s key findings on presenting safety risks across different regulatory documents
  • Analyze concepts from the framework in order to apply these learnings and considerations within their organization
  • Describe real-life examples of how this framework has been used within companies to enhance their process for presenting safety risks

avatar for Anju Garg

Anju Garg

Safety Analyses Innovation and Submission Readiness Lead, Sanofi, United States
Anju has been in the pharmaceutical Industry for over 15 years. After appointments at UCB and Schering Plough, Anju joined Sanofi in 2005. Her career has been predominantly in pharmacovigilance as a Safety Officer at the affiliate and global level. She has gained experience in all... Read More →
avatar for Michelle Geller

Michelle Geller

Executive Medical Director, Global Patient Safety, Amgen Inc., United States
Dr. Michelle Geller has spent the last 12 years of her career at Amgen, currently as an Executive Medical Director in Global Patient Safety and a Safety Therapeutic Area Head for the Immuno Oncology TA. She has also led various other product and process teams in the Amgen Global Patient... Read More →
avatar for Frances McNierney

Frances McNierney

Project Manager (Contractor), TransCelerate BioPharma Inc. , United States
Frances has 9 years of experience in strategic project and change management, product launch, and innovation in the life science industry. After being on the supplier side of the pharmaceutical industry, Frances began working with TransCelerate BioPharma Inc. in 2019. Having managed... Read More →

Wednesday June 15, 2022 2:00pm - 5:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   01: ClinSafety-PV, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial