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Who should attend How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings
Regulatory affairs professionals, Senior management executives (CEO, COO, CFO, etc.), Project managers, Clinical trial specialists, Regulatory compliance associates and managers, People investing in FDA-regulated product development projects
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Seminar Summary:

This two day seminar will provide valuable tips about the logistics, planning, conduct and best practices for all kinds of meetings with the FDA (see full course description)

 
 
 

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Training Course Syllabus:


How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings - FDA Compliance Training Seminar

Course Description:

Despite a few guidance documents to help sponsors prepare for meetings with the FDA, it is a challenge to understand the most efficient and productive ways to strategize, prepare, conduct, and follow-up for these meetings. There are many misconceptions about the expectations from these meetings both for the sponsor and the FDA, and hence many sponsors fail to get the most benefit from them. Over the years, the FDA has also revised processes and practices for meeting with sponsors.

This two day seminar will provide valuable tips about the logistics, planning, conduct and best practices for all kinds of meetings with the FDA. Throughout the workshop, the author will discuss case studies and examples to highlight the common errors and potential solutions. This workshop contains a collection of practical tips from the instructor’s extensive FDA meeting experience. This one-of-a-kind workshop will provide step-by-step instructions and practical tips to the most productive meeting with FDA for all FDA-regulated organizations.

Course Outline:

Day One(8:30 AM – 4:00 PM)

8:30 – 9:00 AM: Registration Process
9:00 AM: Session Start
9:00 – 10:30 AM: Session 1: Kinds of FDA Meetings: Understanding FDA Meetings
Types of meetings: Type A, B, and C
Meetings at different stages of development: pre-IND, End-of-Phase 2, Pre-IDE, Pre-NDA, pre-PMA, etc.
Differences and similarities in meetings for drugs, devices and biologics
FDA criteria for granting or refusing a meeting
Criteria for In-Person and over-the-phone meetings
10:30 – 10:45 AM: Break
10:45 – 12:30 Noon: Session 2: Deciding When to Meet FDA
The “Pre-“ meetings: Pre-IND, pre-NDA, pre-PMA, Pre-Phase 3
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?
12:30 – 1:15 PM: Lunch
1:15 – 2:45 PM: Session 3: Strategy for an FDA Meeting
Collecting available information
Gap Analysis
Listing potential questions
Potential solutions and their FDA acceptability evaluation
To have or not to have a meeting with FDA
2:45 – 3:00 PM: Break
3:00 – 4:00 PM: Session 4: Process for Requesting an FDA meeting
Identifying the contact Division and persons at FDA
The two-step process for a meeting request
Identifying sponsor team members and FDA experts
Identifying information to be included and avoided
Division specific meeting grant criteria: Drugs, biologics and medical devices

Day Two(8:30 AM – 3:30 PM)

Dr. Kazem Kazempour, Former FDA group leader would present in Session 8: Special Considerations for Special Meetings

8:30 – 10:00 AM: Session 5: Meeting Information Package
Format for the meeting information package
Regulatory requirements for content
Scope of the meeting information package
Class exercise: Creating a meeting information package
10:00 – 10:15 AM: Break
10:15 – 12:00 Noon: Session 6: Logistics of an FDA Meeting
Pre-meeting preparatory activities
Reviewing preliminary comments from FDA
Meeting presentations
Role of team leaders and other members
Security processes at FDA and other logistical issues
12:00 – 12:45 PM: Lunch
12:45 – 2:15 PM: Session 7: Conduct of an FDA Meeting: Mock Meeting
Class exercise: Mock FDA meeting to highlight the dos and don’ts of an FDA meeting
Meeting minutes
Follow-up to an FDA meeting
2:15 – 2:30 PM: Break
2:30 – 3:30 PM: Session 8: Special Considerations for Special meetings (By - Dr. Kazem Kazempour, Former FDA group leader)
Periodic meetings: Pre-IND/IDE, End-of-Phase 2, Pre-NDA meetings
Type A urgent issue meetings
Type C miscellaneous meetings
Advisory Committee meetings

Seminar Summary:

This two day seminar will provide valuable tips about the logistics, planning, conduct and best practices for all kinds of meetings with the FDA (see full course description)

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