Wednesday, September 11, 2019 from 8 a.m.- 5 p.m.
This workshop is designed for regulatory professionals and lawyers in the medical device industry to give them insight into FDA regulations. This program has been developed to provide examples and regulatory information through interactive teaching methods, from experts in each field. Attendees will take a hypothetical device from pathways to market, through clinical trials, promotion and advertising and then work through recalls, QSR & MDR reporting and inspections, touching other areas of regulation along the way. PREMARKET WORKSHOP ATTENDANCE NOT REQUIRED TO ATTEND POST MARKET WORKSHOP.
IMDMC Members: $250
Non-members: $300
*Workshop pending approval for CLE credit to legal professionals.
7:30-8:00 a.m. Registration & Breakfast
8:00-8:15 a.m. Welcome
8:15-9:00 a.m. Post-market QSR
9:00-9:45 a.m. Complaint Handling & MDR
9:45-10:00 a.m. Break
10:00-10:45 a.m. Recalls & Field Corrections
10:45-11:30 a.m. Sales & Marketing Regulatory Aspects
11:30 a.m.-12:00 p.m. Lunch
12:00-12:45 p.m. Inspections
12:45-1:30 p.m. Other Liability Mechanism
1:30-1:45 p.m. Break
1:45-2:30 p.m. Enforcement
2:30-3:15 p.m. Risk Management
3:15-4:00 p.m. FDA Recalls & Current Trends
4:00-4:45 p.m. Trademarks & FDA Name Approval
4:45-5:00 p.m. Conclusion
EVENT SPONSORSHIPS ARE AVAILABLE AT THE FOLLOWING LEVELS
GOLD - $1000
SILVER - $500
BRONZE - $250