August 17 at the Holiday Inn Cleveland-Strongsville
10am - 4pm

Sponsored by Schottenstein Zox & Dunn
 

Click Here to Register
$45 for members; $75 for non-members; $30 for full-time students. Lunch is included.


The BioOhio Regulatory Forum 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
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. 
 
Click Here to Register
$45 for members; $75 for non-members; $30 for full-time students. Lunch is included.
 
 
The Holiday Inn Cleveland-Strongsville is located south of Cleveland, right off of I-71.