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Benefits of Advisory Panels

Benefits of Advisory Panels. Explore unmet needs Identify opportunities Review development plans Review protocols Understand patient needs Network. Cost. Direct costs Advisers, Vendors, Venue Indirect costs Company time Hidden costs Success or Failure?. Decision Methods.

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Benefits of Advisory Panels

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  1. Benefits of Advisory Panels • Explore unmet needs • Identify opportunities • Review development plans • Review protocols • Understand patient needs • Network PharmiKom Inc.

  2. Cost • Direct costs • Advisers, Vendors, Venue • Indirect costs • Company time • Hidden costs • Success or Failure? PharmiKom Inc.

  3. Decision Methods • Individual or Directive • Consultative • Consultative Consensus • Modified Consensus • Consensus • Vote Modified from Justice and Jamieson 2006 PharmiKom Inc.

  4. Decision Methods • Individual • Consultative • Consultative Consensus • Modified Consensus • Consensus • Voting PharmiKom Inc.

  5. Consultative Consensus The chairman of the meeting consults with the group members seeking consensus but always keeps control of the decision PharmiKom Inc.

  6. When to use? • When chairman has relevant expertise and/or has a high degree of responsibility for the implementation of decisions • When there is a desire to be collaborative and participative and not alienate participants • When facilitation skills are high in chairman or available through co-chair /neutral facilitator • The sponsor chairs the meeting PharmiKom Inc.

  7. Disadvantages • Time consuming • It may be perceived as manipulative • Requires a high degree of expertise PharmiKom Inc.

  8. Advantages • Avoids deadlock trying to reach full consensus • Chairman is clearly the leader • Participants are more likely to be supportive of decisions that are not their own opinion PharmiKom Inc.

  9. Preparation Good preparation is the key to a successful meeting PharmiKom Inc.

  10. Preparation PharmiKom Inc.

  11. Preparation PharmiKom Inc.

  12. The Meeting Chairman Facilitator PharmiKom Inc.

  13. Outcome • Record/transcription • Meeting Report • Minutes • Executive Summary • Follow up • Evaluation PharmiKom Inc.

  14. Compliance Pharmaceutical Research and Manufacturers of America PharmiKom Inc.

  15. Compliance • Specific CSA • Appropriate advisers • Size • Record keeping • Venue PharmiKom Inc.

  16. Compliance Professional Organizations PharmiKom Inc.

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