BioOhio's Regulatory Forum

BioOhio's Regulatory Forum is less than a month away (August 17), and the agenda is loaded with FDA officials and industry experts...
 
10:00am: Introduction/Logistics 

 
10:10am: Corrections and Removals

• Raymond Ursick - Panel Moderator, REU Associates Inc.
• Gina Brackett - FDA Compliance Officer, FDA Cincinnati District
• Ben Dastoli - FDA Investigator, Brunswick Resident Post
• Laureen Geniusz - FDA Investigator, Brunswick Resident Post
• Joseph Vinhais - Sr. Director Regulatory Affairs and Quality, Philips Medical
• Laura Green - VP Regulatory Compliance and Quality, REU Associates Inc.

 
11:40am: Morning wrap-up

11:55am: Lunch
 
1:00pm: Drug Device Combination Products

• Amy Paukovits - Panel Moderator, Gebauer Company, Director Regulatory Affairs
• Angela Krueger - CDRH Product Jurisdictional Officer, FDA Office of Device Evaluation
• Brenda Fielding - President, REU Associates Inc./Regulus Pharmaceutical Consulting Inc.
• Clara Li, MS - Director, Regulatory Affairs, REU Associates Inc./Regulus Pharmaceutical Consulting Inc.
• Earl LeVere -  Partner, Schottenstein, Zox, and Dunn

 
2:30pm: Clinical Data Requirement to Support 510(k)s

• Sue Chase - Panel Moderator, COO, Clinical Research Management
• Elizabeth Schwendler - Project Manager, Clinical Research Management
• Sandra Maddock - CEO and President, IMARC
• Melissa Masters - Project Manager, Battelle Medical Device Solutions

 
3:30pm: Wrap-up / Open Q&A

3:40 pm - 5:00 pm: Networking
 
 
The 2008 forum drew 120 attendees, which facilitated great industry and professional networking in addition to the valuable content. 
 
$45 for members; $75 for non-members; $30 for full-time students. Lunch is included.
 
 
The Strongsville location is south of Cleveland, right off of I-71.