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Compliance In Focus
Posted by John Lehmann on Wed, Aug 14, 2013

Exclusive Training Aims to Teach the FDA Approval Process for Cardiovascular Clinical Trials

Clinical trials conducted in the Cardiovascular (CV) arena are challenging, first and foremost,Cardivascular Training Event due to the variety of underlying disease states and conditions that affect a majority of potential trial participants. In addition to participants coming into the study with multiple co-morbidities, CV studies themselves can be quite complex.

IMARC Research and CardioMed Device Consultants have partnered to offer an exclusive training specifically geared to explain the FDA approval process for cardiovascular clinical trials. Drawing on expert speakers from the cardiovascular device industry and formerly of the FDA, this intermediate-level training program will guide attendees through the process of going from product idea through clinical development and approval. With a focus on cardiovascular device development and validation, the training will include regulatory strategy, critical elements such as IDE, 510(k), and PMA submissions, clinical trial design, protocol development, human subject protection regulations, and risk-based approaches to clinical trial oversight.

Says Dr. Semih Oktay, former FDA reviewer, academician, and consultant, “It is essential to keep your fingers on the pulse of the rapidly changing and increasingly complex medical device regulatory environment in order to ensure a rapid, smooth pathway to the market for your product. Whether you are a large or small medical device manufacturer, this event is designed to provide practical and to-the-point guidance to help you achieve your product development and marketing goals.”

Speakers will get to the heart of the matter with guidance that isn’t available in any guidance document in order to help attendees better understand how to work with the FDA through this process. Every path to approval is a little different, and having experts focus on your device and your struggles will provide practical solutions. The first 10 attendees to register will be offered 30-minute, one-on-one sessions with former FDA reviewers and industry experts to talk through their particular situations following the course.

Sandra Maddock, CEO and President of IMARC Research, adds, “This isn’t intended to be a seminar that you attend and then forget about in the days or weeks that follow.  This is intended to be a seminar that gives you practical guidance that you can take back to your company and implement immediately.  The small size of this event will help facilitate open and honest discussion about the current climate of the FDA, and what that means to those of us sitting in that room – not what that means to some theoretical situation.”

At the training event, you will:

  • Verbalize an understanding of the FDA medical device approval process
  • Identify strategies for FDA interaction
  • Identify the appropriate regulatory pathway for various product types
  • Discuss requirements for a clinical trial protocol and various protocol design considerations
  • Discuss strategy for risk-based oversight of different types of clinical trials

Don’t miss your chance to sit down with industry experts. Click here to register today!

Photo Credit: Doug88888

Cardiovascular Training Conference


Topics: Sandra Maddock, FDA Approval, Cardiovascular Clinical Trials, Semih Oktay

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