FDAnews Announces — FDA Device Advisory Panel Review Process: How to Ensure Successful Outcomes Webinar, Sept. 24, 2014

Learn how to navigate an advisory panel from an insider’s perspective. FDAnews has teamed Chris Sloan, Principal Consultant at Quintiles Consulting and former FDA device advisory panelist, and Michael Morton, Medtronic’s chief for global regulatory affairs, in a 90-minute presentation on the FDA advisory panel process.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) August 28, 2014

FDA Device Advisory Panel Review Process:
How to Ensure Successful Outcomes
**FDAnews Webinar**
Sept. 24, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/FDADeviceAdvisoryPanel

Devicemakers, what was the toughest test ever taken? Was it the SAT? The GRE? Oral exams for Ph.D. or board certification?

Now, think about FDA advisory panel appearances. Manufacturers are sweating it out while the world looks on including the trade press, the investment community, and competitors too.

Kind of makes the SAT look like patty-cake, doesn’t it?

Learn how to navigate an advisory panel from an insider’s perspective.

FDAnews has teamed Chris Sloan, Principal Consultant at Quintiles Consulting and former FDA device advisory panelist, and Michael Morton, Medtronic’s chief for global regulatory affairs, in a 90-minute presentation on the FDA advisory panel process.

Attendees will discover tips and guidance that are the fruit of a combined five decades of device regulatory experience, including:

  • The various roles of advisory panel participants
  • How much lead time is needed to prepare for advisory panel review?
  • What material of the sponsors will be made public?
  • What will the sponsor know prior to the meeting?
  • What is the protocol for an advisory panel meeting?
  • Who may speak at an advisory panel meeting? And when?
  • What are the possible outcomes of advisory panel review?
  • What does the sponsor do after the panel meets?
  • And much more

Everyone involved in advisory panel presentations ought to participate in this training event. Whether an employee is before the microphones or behind the scenes, old hand or new hire, this session will polish skills and increase the likelihood of FDA approvals.

Meet the Presenters:
Chris Sloan is a Principal Consultant with Quintiles Consulting and former FDA device advisory panelist. As an FDAer from 1990 to 2001 (former Chief of the Interventional Cardiology Devices Branch, Office of Device Evaluation), he was in on precedent-setting issues including drug-eluting stents, intravascular brachytherapy, transcatheter occluders and distal embolization protection, and served as primary contact to devicemakers and consumers on development and regulatory status of interventional cardiology devices. He now assists consulting clients in dealing with U.S. regulatory requirements for device development, focusing on innovative devices and device/drug biologic combination products, regulatory strategy, and regulatory authority communications.

Michael Morton is Vice President for Global Regulatory Affairs at Medtronic, Inc., corporate regulatory affairs. He has 25+ years’ experience in quality, clinical and regulatory affairs with companies including CarboMedics, W.L. Gore, Alcon Labs and Sorin Group. He chairs the AdvaMed PMA Working Group, co-chairs the Pediatric Devices Working Group, and is a member of the Heart Valve Task Force.

Who Will Benefit:

  • Executive management
  • PMA project managers
  • Clinical project specialists
  • Data management and statistics
  • Clinical Investigators and PIs
  • Regulatory affairs
  • Public affairs
  • New hires

Webinar Details:
FDA Device Advisory Panel Review Process:
How to Ensure Successful Outcomes
**FDAnews Webinar**
Sept. 24, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/FDADeviceAdvisoryPanel

Tuition:
$487 per site — includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online: http://www.fdanews.com/FDADeviceAdvisoryPanel
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.