A Carefully Planned Core European Risk Minimization Strategy Is Essential to Ensure Feasibility Across Europe

A Carefully Planned Core European Risk Minimization Strategy Is Essential to Ensure Feasibility Across Europe

Recently we announced the expansion of our Risk Management Services in Europe.  Janine Collins, M.D., has joined UBC and is leading our European Risk Management activities and Medical Safety.  As we knew she would, she’s hit the ground running.  Dr. Collins is attending the 25th Annual DIA EuroMeeting early this week and she’ll be presenting later this week at Late Phase Research/Real World Data.

If you’re attending either conference, be sure to meet her.  Her presentation, Implementing an EU Risk Minimisation Plan in a Heterogeneous Europe, will be of interest to manufacturers with patients in the European market.

Below is a brief synopsis of a portion of her presentation and gives good insight to our clients as they work through multiple regulatory processes in European countries. 

For more information on how UBC can help create Risk Minimization strategies for your product, please contact Dr. Janine Collins.

Current European regulations require that for a centrally approved product, a risk management plan must be submitted. This will be reviewed by the European  PRAC (Pharmacovigilance and Risk Assessment Committee) who will make a recommendation to the Committee for Medicinal Products for Human Use (CHMP). The CHMP in turn makes a recommendation to the European Commission who will either approve or disapprove the application. The European Commission can place the onus on National Regulatory Agencies to take responsibility for ensuring risk minimisation programmes are implemented locally.

 As well as including information regarding the safety profile of the product and how this will be monitored, it is also necessary to specify what activities will be performed to mitigate any risk. In some cases, routine measures only will be required. These include the information provided in the SmPC and the Patient Information Leaflet. In other cases, additional risk minimisation measures will be needed, such as a specific communication/education plan for healthcare professionals and patients, specific tests to be performed prior to prescribing the drug. In some cases, a controlled distribution system will be required to ensure a drug is not dispensed unless certain steps have been performed. This will need to be implemented differently country by country.

 Within each European country, there are variations in regulations, clinical practice, and health care systems.  Therefore,   it is not possible to implement exactly the same programme in each country. However, the market authorisation applicant needs to be sure that when they submit a risk minimisation plan to the CHMP for a central approval, they do not commit to something which cannot be implemented in some countries. It is important that they prepare adequately before submitting a proposal for a central approval. This will involve consulting with internal and external stakeholders (including patients groups, physicians, pharmacists, professional organisations and local regulatory agencies.)

 The effectiveness of the risk minimisation measures will also have to be assessed. Again, this will vary in each country. This may be achieved by specific surveys, such as knowledge , attitude and behaviour surveys, or by specific studies, audits, and  chart reviews.