Completing the set of interactive submissions workshops, industry and FDA experts will lead you through the strategic considerations and practical steps of filing a Premarket Approval.
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Who should attend? Past attendees had titles including:
- Manager of Regulatory Affairs
- Director of Quality and Regulatory Affairs
- Regulatory Affairs Specialist/Associate
- Vice President of Regulatory & Clinical Affairs
- Regulatory Technical Specialist
- Quality Manager
- Director of Global
- ...and many more!
Who else is going? Connect with regulatory professionals from industry-leading companies that include:
- Boston Scientific
- Cardinal Health
- Edwards Lifesciences
- Johnson & Johnson
Agenda topics will include:
- Steps to develop a PMA submission strategy
- Best practices of quality system information for PMA applications
- What to expect during a submission review
- Preparation needed for an advisory panel meeting
- Tips to prepare for an inspection
- Ins and outs of BIMO inspections
- How to deal with unexpected clinical outcomes, animal test results, and adverse panel recommendations
- Needed supplemental submissions for approved PMAs
- Real world case studies
- And more
- Sheena Green, Bioresearch Compliance Branch, CDRH, FDA
- Bleta Vuniqi, Office of Compliance, CDRH
- Laura Bryd, ODE, CDRH
- Abiy Desta, Ombudsman/Quality Assurance Manager, CDRH, FDA
- Tony Blank, Barton & Blank LLC
- Rachael Roehrig, 3D Communications
- Gerard Prud’homme, Hogan Lovells
- Quynh Hoang, King & Spaulding
Bleta Vuniqi is a biomedical engineer within the Respiratory, ENT, General Hospital and Ophthalmic Device Branch of the CDRH Office of Compliance with the Food and Drug Administration. She serves as the PMA team lead within REGO. She was formerly a medical device investigator in the Detroit District Office. She graduated from Wayne State University.
Laura J. Byrd is a member of the PMA staff for the Office of Device Evaluation (ODE) in the Center for Devices and Radiological Health. She oversees incoming and outgoing PMA documents for the office to ensure that PMAs and HDEs approved by ODE are complete, scientifically sound, and in compliance with all regulations. Mrs. Byrd also develops and interprets PMA and HDE policies, regulations, and guidance documents. Prior to joining the PMA Staff in 2003, Mrs. Byrd was a senior scientific reviewer in the Division of Reproductive, Abdominal, and Radiological Devices in ODE for 12 ½ years where she was responsible for reviewing 510(k)/De Novo, IDE, and PMA/HDE submissions. Mrs. Byrd received her Masters of Science in Medical Engineering from The George Washington University and her Bachelors in Electrical Engineering from The Catholic University of America, both in Washington, D.C.
Abiy Desta came to CDRH in 1995 as a contractor to work on a research project funded by the National Institute of Environmental Health Sciences, Department of Energy, and FDA, looking at biological effects associated with exposure to low frequency electromagnetic fields. In 2001 Abiy joined CDRH in the Office of Science and Engineering Laboratories where he continued his research and also helped provide scientific oversight to a series of international research projects funded through a cooperative research and development agreement between FDA and the Wireless Association. In 2008 Abiy joined the Office of the Center Director where he helped coordinate the Center’s response to crosscutting scientific issues such as how CDRH addressed the risk associated the use of Bisphenol A in medical devices. In 2010 Abiy joined the Office of Device Evaluation where he held temporary positions as Acting Deputy Office Director, and Acting Deputy Division Director in the Division of Surgical and Orthopedic Devices. In 2011 Abiy started work as a policy analyst helping develop a number of crosscutting scientific policies including how cybersecurity risks should be addressed in premarket submissions, and on the use of color additives in medical products. In November of 2014 Abiy rejoined the Office of the Center Director as the Ombudsman for the CDRH.
Gerard Prud’homme is a Partner with Hogan Lovells, and his practice is primarily focused on the regulation of medical devices and pharmaceuticals, where he represents both small and large manufacturers with matters before the Food and Drug Administration (FDA). He advises clients on a range of regulatory issues. In the device area, he has extensive experience in assisting companies in matters pertaining to product development and product submissions (510(k)s, IDEs, and PMAs). Gerard advises clients on both regulatory and scientific requirements, and on designing and analyzing clinical studies, in support of product submissions. He regularly counsels companies on issues relating to regulatory strategy, bioresearch monitoring, IRBs, informed consent, advertising and promotion of medical devices, regulatory due diligence reviews, as well as a variety of other FDA matters. Gerard has authored a number of articles and book chapters on topics relating to regulation of medical devices. He also has authored and co-authored scientific articles relating to medical devices, drugs and clinical studies. He is a frequent presenter at medical device and diagnostic seminars and conferences. Prior to becoming an attorney, Gerard spent more than 10 years as a biostatistician with university and nonprofit groups designing and analyzing epidemiological studies and clinical trials of medical devices and drugs. He was also a member of the faculty of the University of Maryland School of Medicine.
Quynh Hoang joined King & Spalding in 2014 after 24 years at the FDA’s Center for Devices and Radiological Health. Her experience at the FDA included 19 years in the premarket review of cardiac, ophthalmic and neurological devices, where she served as an Electrical/Biomedical Engineer Reviewer, Chief of the Vitreoretinal and Extraocular Devices Branch, Chief of the Neurodiagnostic and Neurotherapeutic Devices Branch, and Chief of the Neurodiagnostic and Neurosurgical Devices Branch. Highlights of her accomplishments include leading the review of the first ophthalmic excimer laser systems that are the precursors of todays’ LASIK Eye Lasers and receiving recognition as the FDA’s Peer-Reviewed Expert in Laser Refractive Surgical Devices. For the neurological device area, she was a key contributor to the review policies and to the reorganization that led to the Division of Neurological and Physical Medicine Devices. She has had hands-on experience over a broad breadth of neuro devices, which included diagnostic, endovascular, stimulation and surgical devices. On the postmarket side, Quynh was an Expert Issue Manager tasked with leading teams of premarket, postmarket and communication experts in identifying the response options for the Center.
AdvaMed Member Registration: $1,595
Accel Member Registration: $695
Government and Non-Profit Registration: $695
Non-Member Registration: $2,095
Cancellation and Refund Policy
All cancellations must be received via email to firstname.lastname@example.org(link sends e-mail). Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows".
We welcome substitutions in lieu of cancellations at any time. Please contact us at email@example.com(link sends e-mail) with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.
Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.