Safety Data Exchange Agreements (SDEA)

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a written agreement between the marketing authorisation holder (MAH) and a third party (with whom the MAH has shared activities regarding or impacting pharmacovigilance), which outlines the responsibilities of each party with regards to pharmacovigilance. SDEAs will vary depending on the role being carried out by the 3rd party.

Pharmacovigilance outsourcing and contracting-out drug safety activities can massively reduce expense and workload for any pharmaceutical MAH. However, overall responsibility and oversight of the pharmacovigilance system always remains with the MAH and the EU QPPV.

SDEAs are frequently scrutinized at regulatory inspections and must aid to ensure that global safety information is available at a central point within the EEA, and that clear responsibilities, communication channels and methods for the exchange of safety information is established.

About the speaker
Anne Gramkow

Medical Doctor by training, worked within pharmaceutical industry since 1999 within the pharmacovigilance area – both within clinical and post-marketing safety.
Has been heading a Drug Safety department and acted EU-QQPV for a Danish pharmaceutical company for the past 6 years.
Recently joined the American biotech company Incyte as Senior Director and EU-QPPV. Has been responsible for setting up both clinical and post-marketing pharmacovigilance systems, including handling of Safety Data Exchange Agreement (SEDEAs).

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