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OHDSI community collaboration opportunities with regulators

I wanted to raise your awareness of two recent public announcements from our regulator friends on both sides of the Atlantic.

  1. The US FDA issues a ‘Request for Information’ to support their planning for the next Sentinel Initiative contract(s): https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFI-18-0001/listing.html

From their RFI: "The Food and Drug Administration (FDA) requests public comments to inform the future organization of the Sentinel Initiative. This Request for Information (RFI) offers the public (e.g., researchers, industry, research organizations) the opportunity to provide important information regarding technical and organizational capabilities available, to inform the development of future contract(s) to support activities related to FDA’s Sentinel Initiative. "

Feedback is requested by 1March2018.

  1. The European Medicines Agency (EMA) has issued a ‘call for tender’ for contract services for “Efficacy and safety studies on medicines”: https://etendering.ted.europa.eu/cft/cft-display.html?cftId=2506

An excerpt from their short description of their request: “Post-authorisation effectiveness and pharmacoepidemiology studies to generate data and information to support regulatory decision-making. Research may also focus on the effectiveness of regulatory measures taken and on the impact of relevant legislation. The range of research topics is limited to those with high public health relevance and with a European impact. The scope of the funding covers both nationally and centrally authorised products, including vaccines. The results obtained from this research will subsequently be assessed by the responsible agency committee regarding the need for regulatory action and further research may subsequently also be conducted to measure the effectiveness of regulatory actions taken.”

The four areas they are looking to fund are: 1) Use of innovative methods to optimise the utility of sparse data to support benefit /risk assessment, 2) Qualitative research, 3) Pharmacoepidemiology research — rapid descriptive studies, 4) Pharmacoepidemiology research — association studies, including pregnancy and breastfeeding research.

The proposal deadline is 2Feb2018.

If there is interest in having a community meeting discussion about either/both of these proposals and how OHDSI collaborators can work together as part of meeting the regulators needs, let us know and we can coordinate accordingly.

1 Like

Thank you Patrick. I would interested in being involved in any
discussions and think OHDSI would have plenty of great ideas to
contribute. best, -R

+1 I’m especially interested in the EMA response. It’d be very meaningful to have a community backed point-of-view.

Can coordinate a discussion post-holiday if folks want to iterate.

Thanks, @Patrick_Ryan. The pharmacoepidemiology pregnancy research component will certainly be of interest to the nascent Maternal and Child Health workgroup. Please include @Miriam2 and me in the community discussion.

t