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Topics in Clinical Trials for Medical Devices
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Topics in Clinical Trials for Medical Devices

Publisher: FX Conferences
  • Description

Stay current on the ever-changing medical device regulatory environment with 10 audio recordings of industry experts offering practical guidance on conducting clinical trials.

Ovid and FX Conferences offer thousands of professional development hours for your teams, conveniently packaged and delivered as a collection of audio recordings to save you time and money.

Topics in this collection have a global appeal and are relevant for multiple departments within your organization—R & D, Market Research, Compliance, and more. Each of the 10 recordings consists of a 45-minute, telephone-based presentation delivered by expert international speakers, followed by a 15-minute question-and-answer session (collection available with and without transcripts).


1. Centralized vs Onsite Monitoring – Applying FDA's Risk-based Approach
Speaker: Sandra Maddock, President & CEO, IMARC Research, Inc.

2. An Overview of Recent Risk-based Monitoring Guidance from the FDA
Speaker: Dr. Joy Frestedt, President & CEO, Frestedt Incorporated

3. Best Practices for Source Documentation and Verification
Speakers: Tammi Masters, Senior Clinical Trainer, INC Research

4. Implementing the FDA Guidance on Investigator Responsibility
Speaker: Lorry Witte, RN, BA, CCRC, CCRA, Clinical Research Consultant

5. Monitoring Device Trials: Findings, Recommendations, Corrective Action Plans
Speaker: JoAnn Tyson, CEO & Senior Clinical and Regulatory Affairs Director, J. Tyson & Associates

6. Investigator Brochures for Medical Devices
Speaker: Dr. Joy Frestedt, President & CEO, Frestedt Incorporated

7. Global Clinical Trials & ISO 14155: 2011 Compliance - Are Your Quality Systems Up to Date?
Speaker: Dr. Joy Frestedt, President & CEO, Frestedt Incorporated

8. Conducting Formative and Summative Usability Studies for Medical Devices
Speaker: Adam R. Shames, Director of Human Factors Research, Design Science Consulting, Inc.

9. Conducting Medical Device Studies Under the Revised ISO 14155
Speaker: Janette Benaddi, CEO, Medvance

10. Conducting Clinical Evaluations to Support Regulatory Approval and Marketing of Medical Devices
Speaker: Janette Benaddi, CEO, Medvance

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