IMDMC's 2018 Reg 101 

Tuesday, June 12, 2018 from 8 a.m.- 5p.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.

Members: $250

Non-members: $300

*Reg 101 provides CLE credit to legal professionals. 

Agenda 

7:30-8:00 a.m.              Registration & Breakfast
8:00-8:15 a.m.              Welcome                                                                Diana Caldwell (Pearl Pathways)
8:15-9:00 a.m.              Brief FDA Overview                                              Dale Miller (Zimmer Biomet)
9:00-10:00 a.m.            Pathways to Market - 510 (K) Requirements      Gretchen Bowker (Pearl Pathways)
10:00-10:15 a.m.          Break                                                                      
10:15-11:15 a.m.          Pathways to Market- PMA Requirements           Sharon Kvistad (Navigant)
11:15 a.m.-12:15 p.m.  Pre-Market QSR                                                    Heidi Strunk (PTS Diagnostics)
12:15-1:15 p.m.            Lunch                                                                     
1:15-2:15 p.m.              Clinical Trials/IDE's                                              Jennifer Kerr (Cook Medical)
2:15-3:15 p.m.              Labeling, Advertising & Promotion                    Danny Pettingill (Cook Medical)
3:15-4:30 p.m.              TBA

EVENT SPONSORSHIPS ARE AVAILABLE AT THE FOLLOWING LEVELS

GOLD - $1000 

• Recognition at Workshops
• Half page ad in Workshop Workbooks
• 2 free registrations 

SILVER - $500

• Recognition at Workshops
• Quarter page ad in Workshop Workbooks

BRONZE - $250

• Recognition at Workshops
• Logo and one sentence descriptor in Workshop Workbooks