Course Agenda
Day One – 28 May 2015 (8:30 AM – 6:00 PM) 

8:30 – 9:00 AM: Registration Process

9:00 – 10:30 AM: Session 1: Kinds of FDA Meetings: Understanding FDA Meetings
  • Types of meetings for drug and biologics: Type A, B, and C
  • Types of meetings for medical devices
  • Meetings at different stages of development, milestone meetings: pre-IND, End-of-Phase 2, Pre-IDE, Pre-NDA, pre-PMA, etc.
  • FDA criteria for granting or refusing a meeting
  • Comparison to meetings with EMA and Notified Body

Speakers: Mukesh Kumar, Olga Pavlova

10:30 – 11:00 AM: Break

11:00 – 12:30 Noon: Session 2: Deciding When to Meet Authorities
  • Creating the rationale for a FDA meeting: Pro and con analysis
  • Potential issues for FDA discussion
  • Evaluating available answers
  • Timing the FDA meeting: When is the best time?
  • Coordinating FDA meetings with those with EMA

Speakers: Mukesh Kumar, Beate Schmidt

12:30 – 1:30 PM: Lunch

1:30 – 3:00 PM: Session 3: Strategy for an FDA Meeting
  • Collecting available information
  • Gap Analysis
  • Listing potential questions
  • Potential solutions and FDA acceptability evaluation
  • To have or not to have a meeting with FDA

Speakers: Mukesh Kumar, Daniela Drago

3:00 – 3:30 PM: Break

3:30 – 5:00 PM: Session 4: Meeting Information Package - FDA and EMA requirements
  • Key components of the meeting information package/briefing book
  • Identifying the contact Division and persons at FDA
  • Identifying sponsor team members and FDA experts
  • Identifying information to be included and avoided
  • Division specific meeting grant criteria: Drugs, biologics and medical devices
  • Deciding on attendees, KOLs, others

Speakers: Mukesh Kumar, Olga Pavlova

 5:00 – 6:00 PM: Networking Reception

 
Day Two – 29 May 2015 (9:00 AM – 12:30 PM)

9:00 – 10:30 AM: Session 5: Practical Consideration for Meetings with Regulators  
  • Pre-meeting preparatory activities
  • Reviewing preliminary comments from FDA
  • Meeting presentations
  • Logistics  of meetings
  • Post-meeting follow-up
  • Other ways to interact

Speakers: Mukesh Kumar, Kazem Kazempour

10:30 – 11:00 AM: Break

11:00 – 12:30 Noon: Session 6: Dispute Resolution Meeting, Audit Meetings
  • FDA processes for dispute resolution with its reviewers
  • Best practices to address disagreements with data analysis from clinical trials, product designation, advisory committees
  • Best practices to get FDA on your side 
  • Rules for dispute resolutions with FDA
  • Comparative processes in the EU

Speakers: Salma Michor, Mukesh Kumar

12:30 PM: Adjourn