FDA Regulatory Forum 2014

October 16th, 2014

Bertram Inn & Conference Center in Aurora

Co-located with the BioOhio Annual Conference Road Show

BioOhio is grateful for support from


Laura-Green-LLC-300BioOhio, in partnership with Laura Green, LLC, is once again teaming up with industry experts to bring you a program focused on regulatory issues pertinent to Ohio’s medical products industry, such as the 510(k) process, FDA corrections & removals, FDA warning letters & inspections, changes to EU regulations, and more.

The day will feature presentations by FDA and industry experts, as well as panel discussions for you to ask the experts your unanswered regulatory questions. The event will facilitate great industry and professional networking in addition to the valuable content.

This year, the BioOhio Regulatory Forum will take place simultaneous with the BioOhio Annual Conference Road Show – Northern Ohio. Two events, same venue. Attendees of each event will have several opportunities throughout the day to meet and mingle. We encourage your organization to send someone to each event!


8:45am – 9:30  Registration, Breakfast, Networking

9:30 – 9:35  Introduction

9:35 – 11:15  Changes to EU & IVD Regulations

  • Changes to EU & IVD regulations, and impact to new and existing products, and EU Medical Device Directive changes
  • Sarah H. Stec, Esq., RAC, Legal and Regulatory Director, LNE / G-MED North America, Inc.

11:15 – 11:35  Corrections & Removals

  • Gina Brackett, FDA Compliance Officer, Cincinnati District

11:35 – 12:30  Panel Discussion:  FDA Warning Letter Observations/Inspection Issues

  • Moderated by Laura Green, Consultant, Regulatory Affairs/Quality, Laura Green, LLC
  • Gina Brackett, FDA Compliance Officer, Cincinnati District
  • Ben Dastoli, FDA Investigator, Brunswick Resident Post
  • Laureen Geniusz, FDA Investigator, Brunswick Resident Post
  • Eduard Toerek, President, Q&R Consultant, QUARA Innovations LLC

12:30 – 1:30  Lunch

1:30 – 2:30  510(k) Process: Challenges, changes and efficiencies with eCopy, proposed modification guidance, Refusal to Accept policy

  • Chris Vacca, VP of Regulatory & Quality, CardioInsight Technologies, Inc.
  • Marjorie Shulman, Director, Premarket Notification [510(k)] Program, FDA (presenting via remote video)

2:30 – 3:30  Unique Device Identifier (UDI)

3:30 – 4:00  Human Factors / Usability Engineering

4:00 – 4:10  Open Q&A / R&Q Regulatory 101 Series Update / Closing Remarks

4:10 – 6:00pm  Reception & Networking

The Regulatory Forum will converge with the BioOhio Annual Conference Road Show Northern Ohio for the reception. Enjoy drinks, hors d’oeuvres and networking with speakers and attendees of our Annual Conference.