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After The Inspection When and How to Meet With FDA

After The Inspection When and How to Meet With FDA. Presented by: Michael Santalucia Vice President Global Regulatory Affairs – Vision Care. Medical Device Regulatory, Reimbursement and Compliance Congress – March 2007. “Imagination Is A Poor Substitute For Experience”. (Havelock Ellis).

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After The Inspection When and How to Meet With FDA

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  1. After The Inspection When and How to Meet With FDA Presented by: Michael Santalucia Vice President Global Regulatory Affairs – Vision Care Medical Device Regulatory, Reimbursement and Compliance Congress – March 2007

  2. “Imagination Is • A Poor Substitute • For Experience” (Havelock Ellis)

  3. Agenda • FDA Meeting Lifecycle • Stages of meeting development • Points to consider • Keys to Successful Meeting Management • Discussion/Questions RITPres2-07

  4. The FDA Meeting Lifecycle Deciding to Meet With FDA Preparing for and Conducting the Meeting Follow up Actions and Closure • Factors that may affect the meeting: • Organization’s existing reputation or prior problems • with FDA. • Experiences of competitors • Changes in laws or regulations • Media interest in issues relating to organization’s sector Organizing the message and preparing the facts An event is the dominating issue External The memory lingers…. Commitment is Key Trigger Event • Factors that may affect the company’s ability to organize and manage the meeting: • Past learning's applied to process and policy • Culture • Ability to identify, understand and act on issues • Company business relationships • Consultant advice • Understand the Issue • Why Meet • Timing • Define Purpose, Type and Objective • Does FDA agree • Present the facts • Maintain Intensity of Action • Communicate • Closure Internal

  5. Anatomy of a MeetingThe Decision Stage The event is the dominating issue • Understand the problem • Get the facts, avoid denial • Decide if a meeting is appropriate • Scope of the issue • Purpose, type and objectives • Who will attend (District, Center, Company members) • Does FDA agree • Discuss the meeting request with FDA • What is FDA requirement for timing

  6. Anatomy of a MeetingThe Preparation Stage Organizing the message and preparing the facts • Know the Facts • Be accurate and straightforward • Understand the company commitments • Identify potential questions • Prepare and practice

  7. Anatomy of a MeetingThe Preparation Stage Organizing the message and preparing the facts • Plan your message • Identify your team and roles • Appoint a spokesperson • Be consistent in the message – maintain control • Address the issue • Be concise • Focus on systems not symptoms

  8. Anatomy of a MeetingFollow Up, Commitment and Closure The Memory Lingers ………… • Prepare meeting minutes • Identify the important points of the meeting • Document conclusions and action items • Attach a participant list • Provide meeting minutes to FDA • Focus resources on meeting commitments • Communicate • If timing or plan changes – let FDA know

  9. Anatomy of a Meeting Points to Consider • Have a plan • Identify the key concerns and actions • For updates, provide a brief status • Be consistent with past communications • Understand the issues/gain agreement • Verify that FDA and Company have the same understanding of actions • Gain agreement that the important issues are being addressed • Are the actions appropriate • Identify any open issues RITPres2-07

  10. Anatomy of a Meeting Points to Consider • Know the message • Truthful • Accurate • Consistent • Do not speculate/assume • Team membership • Roles and responsibilities • Limit participation • Consider having an independent person to observe and take notes • Verify everyone knows the facts • Identify FDA and company coordinators RITPres2-07

  11. Anatomy of a Meeting Points to Consider • Follow up • Company • Communicate decisions • Organizational commitment is key • FDA • Provide all information as agreed • Keep to timing • Set achievable goals and targets • Assure there is a process for the company to stay on track. RITPres2-07

  12. Anatomy of a Meeting • Keys to Success • Commitment at the top • Understand the issues • Consistency/clarity of message – know the facts, identify the action plan and don’t waiver without reason. • Stay within the boundaries of prior responses • Correct the system not just symptoms • Understand that meetings alone can not solve the issues at hand. Action is important and meetings are for clarity, timing and milestone communications. • Adopt the lessons learned to the organization’s operations. RITPres2-07

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