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Best Expertise vs Conflicts of Interest: Striking the Right Balance - PowerPoint PPT Presentation

Best Expertise vs Conflicts of Interest: Striking the Right Balance Nikos Dedes, Chair, Positive Voice London, 6 September 2013 General Remarks EMAs speed of response (exceptional) Taxonomy Decision Making Bodies vs Advisory Groups


  1. Best Expertise vs Conflicts of Interest: Striking the Right Balance Nikos Dedes, Chair, Positive Voice London, 6 September 2013

  2. General Remarks EMA’s speed of response (exceptional) Taxonomy Decision Making Bodies vs Advisory Groups (should be further developed) Direct vs Indirect (greatest is not the obvious) Risk Level (defensive attitude) Scarcity of Patient Experts Integrity, Impartiality & Reputation

  3. EMA’s Speed

  4. Various Thoughts EMA’s speed of response (exceptional) Taxonomy Decision Making Bodies vs Advisory (should be further developed) Direct vs Indirect (greatest is not the obvious) Risk Level (defensive attitude) Scarcity of Patient Experts Integrity, Impartiality & Reputation

  5. Risk Level 1

  6. Various Thoughts EMA’s speed of response (exceptional) Taxonomy Decision Making Bodies vs Advisory (should be further developed) Direct vs Indirect (greatest is not the obvious) Risk Level (defensive attitude) Scarcity of Patient Experts Integrity, Impartiality & Reputation

  7. Patient Experts Provide understandable information to patients Engage in, influence, expedite drug Research & Development and Phase IV trial (public or industry) Review Clinical trial protocols and informed consent Participate in Clinical Guidelines, HTA, Pricing, Health Policy, Media Contribute in Benefit/Risk assessment (authorisation & Pharmacovigilance) Strive for optimal balance between: Equitable Access – Health Systems Sustainability – Innovation

  8. Thank You

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