If you are proceeding to Marketing Authorisation Application in Europe, you will need to have developed a Pharmacovigilance System Master File (PSMF) that describes how your system is compliant. This needs to be hosted in the EEA for inspection purposes. We can create this with you and host it for you.
We can also work with you on your Risk Management Plan (RMP) that is an essential part of the submission.
You will also need an EEA QPPV (Qualified Person for Pharmacovigilance) and local contacts/QPPVs throughout EU as required by national law. We can source these from our network of experts and oversee them for you.
When your MAA is successful, you may have additional pharmacovigilance activities in the RMP. We can plan these with you and oversee or conduct the implementation of those activities and help you design ways to evaluate their effectiveness.
Should you require support with all of your post-marketing pharmacovigilance activities we can provide this, ensuring that you remain compliant with the legal obligations of a Marketing Authorisation Holder (MAH). Below are just some of the services we can provide, contact us to discuss how we can assist you:
- Establishing your global pharmacovigilance system
- Provision of EEA QPPV and local PV contacts/ QPPVs
- Provision of Safety Physicians
- Assistance with the EudraVigilance registration process
- Provision of Responsible Person for EudraVigilance
- Data entry and maintenance of product details in the Article 57 database (XEVMPD)
- Pharmacovigilance process gap analysis
- Standard Operating Procedure (SOP) & Work Instruction (WI) preparation
- Preparation, maintenance and hosting of the PSMF
- Pharmacovigilance training
- Preparation, maintenance and submission of RMPs
- Implementation of safety databases
- Individual case safety report (ICSR) management from receipt to expedited reporting
- Literature searching services
- Safety signal management
- Risk minimisation activities
- Preparation, review and submission of Periodic Safety Update Reports/ Periodic Benefit-Risk Evaluation Reports/ Periodic Adverse Drug Experience Reports (PSUR/PBRER/ PADER)
- Preparation or review of Safety Data Exchange Agreements
- Pharmacovigilance system, process and document audits
- Support prior to & during pharmacovigilance Regulatory Inspections, including inspection readiness training
- Corrective action/ preventive action (CAPA) preparation
- Guidance & advice during integration of pharmacovigilance systems following company mergers/ acquisitions
- Interim pharmacovigilance support during busy periods/ staff shortage