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Pharmacovigilance Compliance: Market Research and Patient Support Program
Our client needed help with:
- Our client had received critical inspection findings from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) related to non-compliance with Pharmacovigilance (PV) regulatory requirements.
- They needed to improve their 90+ affiliate organizations’ oversight of, and adherence to, standard operating procedures (SOPs) for some 10,000 retrospective Market Research and Patient Support Programs.
- A previous effort to resolve this situation proved unsuccessful due to the adoption of a local rather than central approach.
Our approach:
- We partnered with client to develop a centralized strategy to secure comprehensive and consistent data in time for an imminent repeat MHRA inspection.
- We brought our technical and subject mater expertise to play and worked with the IT groups to developed an tool to monitor data clean up and worked closely with the Affiliate organizations leading training and supporting their efforts to ensure that they delivered on their commitments.
The results:
10,000
Market research Patient Support Programs and assessed
90
Affiliates reviewed and where required, remediation plans created
How we delivered these results:
- We provided strong project management support to keep our client’s project team focussed and delivering against the objectives and worked closely with the Quality and Safety groups to ensure the approach and progress met with their approval.
- All Corrective and Preventative Actions related to the retrospective programs were completed, and our client was ready for the next MHRA inspection from this perspective. Additionally, oversight was achieved and the quality of supporting data now meets regulatory requirements. Through the work of this project, senior management PV awareness has improved.