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Course Agenda
Day One (8:30AM - 3:30PM)
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8:00 – 8:30 AM: Registration

8:30 – 10:00AM: Lecture 1: Types of Crises Specific to the Medical Product Industry
  • Historical overview of FDA regulations
  • Type of crises: Technological, Regulatory and Organizational
  • Perspectives in anticipating and dealing with crisis
  • Managing public and private information dissemination of information
  • Specific issues for FDA related industry
  • Strategic communication planning for good and bad times
  • Impact of FDA decisions on regulatory decisions in ROW
10:00 – 10:15AM: Break
 
10:15 – 12:00 noon: Lecture 2: Changing Trends in Drug Discovery Research
  • Issues with research grade material used for laboratory and non-clinical testing
  • GLP and non-GLP data to support an IND
  • GMP and non-GMP issues to support INDs at different stages
  • Managing and utilizing intellectual property for development and IND/IDEs
  • Assessing IND readiness and FDA acceptability of an IND
  • Assessing need for clinical trials for non-prescription products such as HCTs
 
12:00 – 12:45PM: Lunch
 
12:45 – 2:15PM: Lecture 3: Managing Safety Information
  • Basics of clinical trial safety reporting to and public
  • Handling suspending and terminating clinical trials
  • FDA meetings for safety issues
  • Amending clinical protocols and Investigator’s brochures
  • Amending informed consent and re-consenting trial participants without prejudice
  • Educating investigators and teams about safety issues
 
2:15 – 2:30AM: Break
 
2:30 – 3:30PM: Lecture 4: Post-Market Safety Events and Product Recalls
  • Best practices for pharmacovigilance
  • Managing and reporting post-market safety information
  • Registry clinical trials and patient surveys
  • Physician focus groups
  • Product recalls without long-term pain to the manufacturer
  • Handling drug shortages and manufacturing crises 
Day Two (8:30 AM - 3:30PM)

8:30 – 10:00AM: Lecture 5: Regulatory Crises During the Investigational Phase of Development
  • Meeting FDA reviewers and other ways to interact
  • Issues with recruitment into trials
  • Adaptive clinical trial designs and high placebo effect
  • Best practices for meetings with the FDA for drugs, biologics and medical devices
  • Handling different regulatory jurisdictions for multinational trials

10:00 – 10:15AM: Break
 
10:15 – 12:00 noon: Lecture 6: Dispute Resolution with the FDA
  • FDA guidance documents on dispute resolution with reviewers and sponsors
  • Best practices to address disagreements with data analysis from clinical trials
  • Trouble-shooting private meetings with FDA and advisory committee meetings
  • Best practices to get FDA on your side
  • Rules for dispute resolutions with FDA
  • When to involve legal experts and when to avoid

12:00 – 12:45PM: Lunch
 
12:45 – 2:15PM: Lecture 7: Negative Findings from an FDA Audit
  • Best practices for dealing with an FDA audit
  • Responding to FDA 483s, Warning Letters, and Untitled Letters
  • Time to audit findings, response and FDA action
  • Strategic use of technology for media and investor relations: Press releases and other public announcements
  • Fraud detection, management, and avoidance
  • Affect of the Park Doctrine, and other punitive actions by FDA

2:15 – 2:30AM: Break

2:30 – 3:30PM: Lecture 8: Off-Label Uses, Promotions and Whistle Blowers
  • FDA accepted definition of off-label, in-label, published and anecdotal information.
  • FDA guidance documents about off-label promotion.
  • Review of case-studies from unsuccessful and successful promotion of off-label uses.
  • Practical tips for training of sales and marketing teams in off-label uses of products.
  • Best practices to encourage internal dispute resolutions and reducing events worth whistle-blowing
  • Regulatory strategies for converting off-label uses to in-label uses