FDA and industry experts are coming together to teach you the basics of IDE submissions.
This course has been pre-approved by RAPS as eligible for up to 6 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:
- The purpose of an IDE
- Tips on making the best use of pre-submission meetings
- Components of a successful IDE submission
- Common errors and deficiencies in an IDE application
- The ins and outs of BIMO inspections
- Details about the regulatory requirements needed during trial conduct
- And more
- Veronica Calvin, Supervisory Consumer Safety Officer, CDRH
- Anna Schroeder, Biomedical Engineer, IDE Program, CDRH, FDA
- Tony Blank, Barton & Blank LLC
- Gerard Prud’homme, Hogan Lovells
- Moj Eram, PhD, Co-Founder and Sr. Partner, Sage BioPartners; MasterControl Strategic Partner
Veronica Calvin is a Supervisory Consumer Safety Officer in the Division of Bioresearch Monitoring (BIMO), in CDRH’s Office of Compliance. Ms. Calvin oversees compliance and enforcement activities relating to medical device clinical and non-clinical research. Prior to joining BIMO in 2007, Ms. Calvin held positions in the Office of In Vitro Diagnostic Device Evaluation and Safety (now OIR) and the Office of Device Evaluation, as senior Scientific Reviewer and Designated Federal Officer for Medical Device Advisory Committees. Ms. Calvin also worked as a Laboratory Analyst in FDA’s Baltimore District Office and holds a master’s degree in biology.
Anna Schroeder is a Biomedical Engineer in the Investigational Device Exemption (IDE) program in the Center for Devices and Radiological Health at the FDA. Anna joined the FDA in 2012 after receiving her Biomedical Engineering degree from Duke University. She began her FDA career as a premarket reviewer in the Implantable Electrophysiological Devices Branch in the Division of Cardiovascular Devices (DCD) before joining the IDE program to focus on clinical trials for medical devices.
Tony Blank is Cofounder and Senior Advisor at Barton & Blank LLC, a specialized regulatory consulting firm for the medical device and combination products industry. Mr. Blank has served in a variety of roles in the medical products industry - including Clinical and Regulatory - for the past 25 years. Most recently, Mr. Blank spent 12 years at Boston Scientific Corporation in both Corporate and Business regulatory leadership roles, including Vice President of Regulatory Affairs for the CRV businesses (Cardiology, Rhythm and Vascular). Under his leadership, the Boston Scientific obtained numerous regulatory approvals for medical devices and combination products. Among these are world-wide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resychronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Mr. Blank has likewise been an active representative for Boston Scientific, the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups – including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he cochaired). He is very involved in developing and delivering meaningful educational programs in the field of Regulatory Affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Mr. Blank has worked with Cardiopulmonary, Surgical, Ophthalmic, Vascular Access and Critical Care medical devices.
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.
Moj Eram is a Co-founder and Senior Partner at Sage BioPartners, specializing in providing quality, compliance, regulatory, product development, and CMC solutions to medical device, diagnostics, and pharma companies. She has been a consultant and strategic partner with MasterControl for the five years, where she focuses on the creation and implementation of quality management systems, medical product/software development, regulatory affairs, and software validation. Eram has extensive experience in academic research and technology commercialization in addition to expertise in regulatory affairs, quality, and compliance.
AdvaMed Member Registration: $995
Accel Member Registration: $695
Government and Non-Profit Registration: $695
Non-Member Registration: $1,295
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.