FDA Regulatory Forum 2015

September 2015

Laura-Green-LLC-300Each year BioOhio teams up with Laura Green, LLC, representatives from the FDA, and industry experts to bring you a program focused on regulatory issues pertinent to Ohio’s medical products industry, such as EU regulations, clinical study considerations, the 510(k) process, purchasing controls, warning letters, inspections, UDI implementation and more.


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

The Regulatory Forum is consistently one of our most popular and well attended events.

The BioOhio Regulatory Forum is made possible by generous sponsorship of companies and organizations that value the power of partnerships and networking.

2015 Agenda

8:30am – 9:20: Registration & Networking

9:20 – 9:30: Welcome Remarks

  • John F. Lewis, Jr., President & CEO, BioOhio
  • Laura Green, Principal, Laura Green, LLC

9:30 – 10:15: EU Medical Device and IVD Regulatory Evolutions

Overview of the EU medical device and IVD regulatory scheme currently and where the revisions are in the process.  Examining clinical data and evaluations – Requirements, process, what the regulations may expect in the future.  Examining risk management – Requirements, process, what the regulations may expect in the future.

10:15 – 10:45: Clinical Study Considerations for Medical Devices & Drugs

  • Brandy Chittester, MS, CCRA, Chief of Clinical Operations, IMARC Research

10:45 – 11:15: A Case Study:  Establishing a Compliant Medical Device Manufacturing Organization

Company leaders will share their strategy, experiences and progress in transitioning from a well-established Industrial focused company to a FDA compliant medical device company.

11:15 – 12:00: Purchasing Controls

  • Gina Brackett, Compliance Officer, Cincinnati District, FDA

12:00 – 12:45pm: Lunch & Networking

12:45 – 2:00: Managing FDA Warning Letters, Inspections & FDA Inspection Issues and Expectations

  • Melinda Novatny, Senior Director of Quality, Integra LifeSciences
  • Gina Brackett, Compliance Officer, Cincinnati District, FDA
  • Christine Kelley, Investigator, Cincinnati District, FDA
  • Laura Green, Principal, Laura Green, LLC

2:00 – 3:00: 510(k) & De Novo Processes

Update via video-conference on De Novo Process:  Direct De Novo & Keys to Success; Successful Pre-Submission Meetings & FDA 510(k) Trends

  • Marjorie Shulman, Director, Premarket Notification [510(k)] Program, FDA
  • Sergio de del CastilloDe Novo Policy Analyst, FDA
  • Felipe Aguel, Ph.D., Policy Lead, Q-Submission Program, FDA

3:00-3:45: UDI Implementation: Our Progress, Lessons-Learned & FDA Interpretations

3:45 – 4:30: Networking Reception