Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 2):
Introduction:
Risk minimisation measures are interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Planning and implementing risk minimisation measures and assessing their effectiveness are key elements of risk management. The guidance provided in this Module should be considered in the context of the wider GVP guidance, in particular in conjunction with GVP Module V.
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Table of contents
XVI.B. Structures and
processes
XVI.B.2. Risk minimisation
measures
XVI.B.2.1. Educational
programme
XVI.B.2.1.1. Educational tools
XVI.B.2.1.1.1. Educational
tools targeting healthcare professionals
XVI.B.2.1.1.2. Educational
tools targeting patients and/or carers
XVI.B.2.2. Controlled access
programme
XVI.B.2.3. Other risk
minimisation measures
XVI.B.2.3.1. Controlled
distribution system
XVI.B.2.3.2 Pregnancy
prevention programme
XVI.B.2.3.3. Direct health care
professional communication (DHPC)
XVI.B.3. Implementation of risk
minimisation measures
XVI.B.4. Effectiveness of risk
minimisation measures
XVI.B.4.1.1. Reaching the
target population
XVI.B.4.1.2. Assessing clinical
knowledge
XVI.B.4.1.3. Assessing clinical
actions
XVI.B.6. Quality systems of
risk minimisation measures
XVI.C. Operation of the EU
network
XVI.C.1. Roles and
responsibilities within the EU regulatory network
XVI.C.1.1. The European
Medicines Agency
XVI.C.1.2. The Pharmacovigilance
Risk Assessment Committee (PRAC)
XVI.C.1.3. Competent
authorities in Member States
XVI.C.2. Roles and
responsibilities of the marketing authorisation holder or applicant in the EU
XVI.C.3. Healthcare
professionals and patients
XVI.C.4. Impact of risk
minimisation measures effectiveness on RMP/PSUR in the EU
XVI. Appendix 1. Key elements
of survey methodology
XVI.App1.1. Sampling procedures
and recruitment strategy
XVI.App1.2. Design and
administration of the data collection instrument(s)
XVI.App1.3. Analytical
approaches
XVI.App1.4. Ethics, privacy and overall study feasibility
EMA GVP Module 16:
