Completed
This workshop series provided a venue for stakeholders to discuss structured approaches to characterize and communicate the sources of uncertainty in benefit-risk assessment in drug development and their implications on pharmaceutical regulatory decisions. The workshop was hosted by the National Academies Forum on Drug Discovery, Development and Translation.
Please visit our event pages for additional information and meeting materials for the workshop (held on February 12 and May 12, 2014).
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Workshop
ยท2014
Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process i...
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Description
An ad hoc planning committee will plan 2 one-day public workshops that will address the need to advance the development of more systematic and structured approaches to characterize and communicate: a) the sources of uncertainty in the assessment of benefits and risks; and b) their implications on pharmaceutical regulatory decisions. Specifically, the workshop will explore potential analytical and communication approaches and identify key considerations on their development, evaluation, and incorporation into pharmaceutical benefit-risk assessment. Uncertainty in drug review and decision-making can arise from many sources. This workshop will consider the entire drug development lifecycle, including pre-market drug review and post-market safety surveillance. Subject matter experts will be invited to participate in the workshop through presentations and discussions that will:
- Discuss the challenges in applying more systematic approaches to characterizing and communicating uncertainty in the assessment of a drug's benefits and risks.
- Identify potential approaches to characterize uncertainty in pharmaceutical benefit-risk assessment, drawing from various scientific and regulatory disciplines and domains.
- Identify possible principles, best practices and resources that can facilitate the development, evaluation and incorporation of such approaches in regulatory decision-making.
- Explore principles and approaches to facilitate the communication of uncertainty in benefit-risk assessment to stakeholders, including the public.
The planning committee will develop the agenda for each workshop, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A single individually authored brief workshop summary will be prepared by a designated rapporteur based on the information gathered and the discussions held during the first workshop in the series. A single individually authored summary of the workshops will be prepared by a designated rapporteur based on the information gathered and the discussions held during the workshops.
Collaborators
Committee
Co-Chair
Co-Chair
Member
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Sponsors
Department of Health and Human Services
Private: For Profit
Private: Non Profit
Staff
Anne Claiborne
Lead
Major units and sub-units
Center for Health, People, and Places
Lead
Health and Medicine Division
Lead
Institute of Medicine
Lead
Board on Health Sciences Policy
Lead
Biomedical and Health Sciences Program Area
Lead