Pharmacovigilance
Pharmacovigilance: Your concerns addressed by our experts!
Since pharmacovigilance is a field that requires scientific, pharmaceutical and medical knowledge, Medipha Santé has put in place a solid pharmacovigilance strategy for you and our team brings together expertise in the following areas: knowledge of medicines, mastery of regulations and quality assurance.
The legal framework for our pharmacovigilance services for medicines marketed in the European Union is defined by Regulation (EC) No 726/2004, as amended by Regulation (EU) No 1235/2010, by Directive 2001/83/EC, as amended by Directive 2010/84/EU, and by Implementing Regulation (EU) No 520/2012, as amended in particular by Implementing Regulation (EU) 2025/1466. The Good Pharmacovigilance Practice (GVP) guidelines, as well as the relevant ICH and CIOMS guidelines, supplement this framework and guide the conduct of our pharmacovigilance activities.
Medipha Santé offers you, among other things, the following services:
set up your pharmacovigilance system (including the development of Safety Data Exchange Agreements (SDEA) with your partners/distributors) and keep the Pharmacovigilance System Master File (PSMF) up to date
Training for all parties involved in your pharmacovigilance system, initial or ad hoc training for all your staff or staff responsible for medical information activities, quality complaints, clinical trials, telephone switchboard, customer service, sales, marketing, legal affairs, regulatory affairs, commercial activities or "Business development" and audits
Prepare and maintain the risk management plan (RMP)
implement a document search management (screening) system
to conduct a review of international literature
to conduct a literature review of French and Francophone literature, in accordance with Good Practice Guidelines (GPGs), using a list of non-indexed journals regularly updated according to the therapeutic areas covered.
Registration of medicines and management of the European electronic dictionary (XevmpD) in accordance with Article 57 of Regulation 726/2004/EC
establish and maintain an electronic Pharmacovigilance database compliant with the E2BR3 standard
plan and conduct PV audits
Collect, monitor, manage and transmit individual pharmacovigilance cases (ICSR) to Eudravigilance
Coding of adverse events (AEs) according to the MedDRA dictionary
Attribution according to the French attribution method or Bégaud method
Performing signal detection activities
Similarly, writing reports:
Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR), Periodic Benefits and Risk Assessment Report (PBRER)
As part of our pharmacovigilance services, we provide the services of the Qualified Person in Pharmacovigilance (QPPV) and/or, for France, the Local Reference Person in Pharmacovigilance (RPV).
If you hold a marketing authorization (MA), we can therefore
to be your single point of contact with the relevant authorities 24 hours a day (pharmaceutical service)
monitor your pharmacovigilance system and help you implement the appropriate changes
actively participate in the success of your Pharmacovigilance system
Medipha Santé will review the safety profiles, monitor the evolution of the benefit/risk profile of your medications and will be in contact with the relevant authorities on your behalf.
