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Risk Management Plan (RMP) : A New
Paradigm in Pharmacovigilance
Dr Vineet Shastri, MD
(Anesth.& Critical Care Medicine)
Director, Pharmacovigilance
Quintiles
Disclaimer
• The views and opinions expressed in the following
PowerPoint slides are those of the individual
presenter and should not be attributed to the
institution, its directors, officers, employees,
volunteers, members, chapters, councils, Special
Interest Area Communities or affiliates, or any
organization with which the presenter is employed or
affiliated.
• These PowerPoint slides are the intellectual property
of the individual presenter.
• Risk Management Plan (RMP)
– A detailed description of the risk management system [DIR
Art 1(28c)]
• Risk management system
– US A set of pharmacovigilance activities and interventions
designed to identify, characterise, prevent or minimise risks
relating to medicinal products including the assessment of
the effectiveness of those activities and interventions [DIR
Art 1(28b)]
Definition
Principles of Risk Management
• Directive 2001/83/EC
– Article 8 (3), Article 21a, Article 22a, Article 22c, Article
104, Article 106(c), Article 127a
• Commission Implementing Regulation (EU) No. 520/512
– Article 30, Article 31, Article 32, Articles 33, Annex 1
• Regulation (EC) No 726/2004
– Article 6, Article 9(4), Article 10a, Articles 23(3), Article
26(c)
• Regulation (EC) No 1901/2006
– Article 34
• Regulation (EC) No 1394/2007
– Article 14
Legal Basis
• With an application involving a significant change to an existing
marketing authorisation
– new dosage form
– new route of administration
– new manufacturing process of a biotechnologically-derived
product
– Paediatric indication
– Other significant change in indication
• At the request of health authorities upon identifying a significant
new safety concern
• With a PSUR for single centrally authorised medicinal product,
when the changes to the RMP are a direct result of data presented
in the PSUR
When
Modules and Parts of RMP
Part I Product(s) overview
Part II Safety specification
– Module SI Epidemiology of the indication(s) and target population(s)
– Module SII Non-clinical part of the safety specification
– Module SIII Clinical trial exposure
– Module SIV Populations not studied in clinical trials
– Module SV Post-authorisation experience
– Module SVI Additional EU requirements for the safety specification
– Module SVII Identified and potential risks
– Module SVIII Summary of the safety concerns
Part III Pharmacovigilance plan
Part IV Plans for post-authorisation efficacy studies
Part V Risk minimisation measures (including evaluation of the effectiveness
of risk minimisation measures)
Part VI Summary of the risk management plan
Part VII Annexes
Information structure in RMP
Part III- Pharmacovigilance Plan
Safety concernsSafety concerns
Pharmacovigilance PlanPharmacovigilance Plan
Identify &
characterise
Risk Minimization
Risk Minimization PlanRisk Minimization Plan
Risk Minimization MeasuresRisk Minimization Measures
Minimize &
prevent risk
RMP_14th Annual Conference of Society of Pharmacovigilance and International Symposium on Safe Medicine and Safe Patient
RMP_14th Annual Conference of Society of Pharmacovigilance and International Symposium on Safe Medicine and Safe Patient
WHY?
Ethical
Dying from a disease is sometimes
unavoidable; dying from a medicine
is unacceptable
Legal
Civil and criminal Lawsuits,
imprisonments, penalties
Phamaco-econimics
ADRs are expensive!!
•6.5% of admissions are due to ADRs.
•Cost of drug related morbidity & mortality exceeded $177.4 billion
in 2000
Regulatory
Regulators expects continuous and
close scrutiny and monitoring of
drug safety
Thank You

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RMP_14th Annual Conference of Society of Pharmacovigilance and International Symposium on Safe Medicine and Safe Patient

  • 1. Risk Management Plan (RMP) : A New Paradigm in Pharmacovigilance Dr Vineet Shastri, MD (Anesth.& Critical Care Medicine) Director, Pharmacovigilance Quintiles
  • 2. Disclaimer • The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to the institution, its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. • These PowerPoint slides are the intellectual property of the individual presenter.
  • 3. • Risk Management Plan (RMP) – A detailed description of the risk management system [DIR Art 1(28c)] • Risk management system – US A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products including the assessment of the effectiveness of those activities and interventions [DIR Art 1(28b)] Definition
  • 4. Principles of Risk Management
  • 5. • Directive 2001/83/EC – Article 8 (3), Article 21a, Article 22a, Article 22c, Article 104, Article 106(c), Article 127a • Commission Implementing Regulation (EU) No. 520/512 – Article 30, Article 31, Article 32, Articles 33, Annex 1 • Regulation (EC) No 726/2004 – Article 6, Article 9(4), Article 10a, Articles 23(3), Article 26(c) • Regulation (EC) No 1901/2006 – Article 34 • Regulation (EC) No 1394/2007 – Article 14 Legal Basis
  • 6. • With an application involving a significant change to an existing marketing authorisation – new dosage form – new route of administration – new manufacturing process of a biotechnologically-derived product – Paediatric indication – Other significant change in indication • At the request of health authorities upon identifying a significant new safety concern • With a PSUR for single centrally authorised medicinal product, when the changes to the RMP are a direct result of data presented in the PSUR When
  • 7. Modules and Parts of RMP Part I Product(s) overview Part II Safety specification – Module SI Epidemiology of the indication(s) and target population(s) – Module SII Non-clinical part of the safety specification – Module SIII Clinical trial exposure – Module SIV Populations not studied in clinical trials – Module SV Post-authorisation experience – Module SVI Additional EU requirements for the safety specification – Module SVII Identified and potential risks – Module SVIII Summary of the safety concerns Part III Pharmacovigilance plan Part IV Plans for post-authorisation efficacy studies Part V Risk minimisation measures (including evaluation of the effectiveness of risk minimisation measures) Part VI Summary of the risk management plan Part VII Annexes
  • 9. Part III- Pharmacovigilance Plan Safety concernsSafety concerns Pharmacovigilance PlanPharmacovigilance Plan Identify & characterise
  • 10. Risk Minimization Risk Minimization PlanRisk Minimization Plan Risk Minimization MeasuresRisk Minimization Measures Minimize & prevent risk
  • 13. WHY? Ethical Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable Legal Civil and criminal Lawsuits, imprisonments, penalties Phamaco-econimics ADRs are expensive!! •6.5% of admissions are due to ADRs. •Cost of drug related morbidity & mortality exceeded $177.4 billion in 2000 Regulatory Regulators expects continuous and close scrutiny and monitoring of drug safety