Pharmacovigilance: Our experts take care of your pharmacovigilance concerns!
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 unites expertise in the following areas: medicines knowledge, regulatory control and quality assurance.
The legal framework for our pharmacovigilance services for medicinal products marketed in the EU is defined in Regulation (EC) No 726/2004 as amended by Regulation (EU) No 1235/2010, Directive 2001/83/EC as amended by Directive 2010/84/EU and Regulation (EU) 520/2012. In addition, the Good Practice Guidelines on Pharmacovigilance (GVP), the French Bonnes pratiques de Pharmacovigilances and the relevant guidelines of the ICH and CIOMS provide the framework for 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 maintain the Pharmacovigilance System Master File (PSMF) up to date
- training of all parties involved in your pharmacovigilance system, initial or ad hoc training of all your staff or personnel in charge of medical information activities, quality claims, clinical trials, switchboard, customer service, sales, marketing, legal affairs, regulatory affairs, commercial activities or “Business development” and audits
- prepare and maintain the risk management plan (RMP)
- set up a documentary research management system (screening)
- monitor international literature
- monitor French and French-speaking literature, in accordance with the BPPV, on a list of non-indexed journals regularly updated according to the therapeutic areas covered
- Registration of medicinal products 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 carry out PV audits
- Collect, monitor, manage and transmit to Eudravigilance individual pharmacovigilance cases (ICSR)
- Adverse event (AE) coding according to the MedDRA dictionary
- Accountability according to the French accountability method or Bégaud method
- Carrying out signal detection activities
As well as writing reports:
- Periodic Safety Update Reports (PSUR), Development Security Update Reports (DSUR), Periodic Benefit 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 Responsible Person for Pharmacovigilance (LPVRP).
If you hold a marketing authorization (MA), we can:
- be your single point of contact for the competent authorities 24 hours a day (pharmaceutical permanence)
- supervise your pharmacovigilance system and help you implement 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 drugs and will be in contact with the relevant authorities on your behalf.
Are you a patient, pharmaceutical company or health professional who wishes to report an adverse drug reaction?