Overview Detailed Agenda Speaker Price/Registration Venue
Course Agenda
Day One (8:30AM - 3:30PM)
8:00 – 8:30 AM: Registration 8:30 – 10:00AM: Lecture 1: Types of Crises Specific to the Medical Product Industry
10:15 – 12:00 noon: Lecture 2: Changing Trends in Drug Discovery Research
12:00 – 12:45PM: Lunch 12:45 – 2:15PM: Lecture 3: Managing Safety Information
2:15 – 2:30AM: Break 2:30 – 3:30PM: Lecture 4: Post-Market Safety Events and Product Recalls
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Day Two (8:30 AM - 3:30PM)
8:30 – 10:00AM: Lecture 5: Regulatory Crises During the Investigational Phase of Development
10:00 – 10:15AM: Break 10:15 – 12:00 noon: Lecture 6: Dispute Resolution with the FDA
12:00 – 12:45PM: Lunch 12:45 – 2:15PM: Lecture 7: Negative Findings from an FDA Audit
2:15 – 2:30AM: Break 2:30 – 3:30PM: Lecture 8: Off-Label Uses, Promotions and Whistle Blowers
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