Detailed Description (DDPS)
EU Directive 2001/83/EC requires each Marketing Authorisation Application (MAA) to include a Detailed Description of its Pharmacovigilance System, including a named Qualified Person for Pharmacovigilance for Europe. Volume 9A is specific on the elements of pharmacovigilance that should be included in the DDPS, but in general leaves it to the Applicant to provide the detail. PrimeVigilance consultants have extensive experience in developing Volume 9A compliant Pharmacovigilance Systems and describing them in MAAs.
First of all, key stakeholders from both the client company and PrimeVigilance meet to finalise roles and responsibilities. Marketing partners, sales and distribution network, manufacturing site, CROs, and any other partners and vendors will also be discussed so that organisations chart and communication channels can be mapped. Documented procedures are reviewed to determine which subjects, if any, need to be written or amended.
This information is integrated into PrimeVigilance’s DDPS template, ready for review by the client and finalization in good time for the submission of the Marketing Authorisation Application. But it doesn’t end there. We can help by writing your SOPs, setting up your safety committee, mentoring your staff, informing your management, putting the mechanisms in place : whatever it takes to get your show on the road.
Detailed Description of Pharmacovigilance System: Compliance and Quality
just one of the pharmacovigilance services from PrimeVigilance
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