Clinical Trials - Medical Device FDA's Program 2017
- Start Date:
- Thursday, 24 August, 2017
- End Date:
- Thursday, 24 August, 2017 11:00am
- Health & Nutrition
Overview:The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Why should you Attend:In spite of the long experience device companies have with clinical trials regulations (published 25 years ago), many companies have found this area an expensive trap. In fact, the only thing more expensive than a good clinical trial is a bad clinical trial.Areas Covered in the Session:IntroductionValid Scientific EvidencePhases of Device Human StudiesSignificant/Non-Significant RiskIDE Meaning, Content, ReviewExemption from IDE rulesWho Will Benefit:R&D and Regulatory StaffManagement of R&D RegulatorySpeaker Profile:Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law.
The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups.Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Netzealous LLC DBA - Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- Netzealous LLC DBA - Compliance4All