Ensuring that the right patients get the right treatments at the right time

Risk Management Plans and Effectiveness Studies

Risk Management Plans (EU-RMP, REMS) are requested by regulatory authorities to help control product risks post-approval. These plans can include different types of educational programs, pre-certification and controlled distribution.

Mapi supports our clients through all phases of Risk Management Plan writing, regulatory authority negotiation, strategy development, program execution, evaluation of effectiveness, program redesign and program closeout.

Relevant recent regulatory guidance on Risk Management Plans (EU-RMP, REMS):

FDA

  • Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications
  • Guidance Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)

EMA – Good Pharmacovigilance (GVP) Modules

  • V: Risk Management Systems

In addition, these plans also need to include studies to evaluate the effectiveness of these activities in relation to health care provider and patient understanding of the program and the product risks. These studies are usually questionnaire based surveys to assess knowledge and behaviour following product launch in multiple countries.

Relevant recent regulatory guidance on these evaluation studies include:

FDA

  • Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)

EMA – Good Pharmacovigilance (GVP) Modules

  • XVI: Risk minimization measures – selection of tools and effectiveness indicators

Request a consultation with an RWS&A expert