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Compliance In Focus
Posted by John Lehmann on Wed, Sep 12, 2012

21 CFR 312 vs. 812: What’s the Difference?

312 812 whats the differenceOn Thursday, September 6th, BioEnterprise hosted an event at Corporate College in Cleveland, Ohio. The training event focused on the differences between investigational drug and medical device clinical trials.  Featured speakers for the event were Sandra Maddock, CEO and President of IMARC Research and Brandy Smith, Chief of Clinical Operations for IMARC Research.

Whether you are investigating drugs or devices, the common thread that ties the seemingly different clinical research processes, requirements, and regulations together is simple - patients. So while these products may have their differences, the goal is to safeguard patients and bring innovative products to market as quickly as possible.

To do so, it’s important to understand the similarities and differences and appreciate the similarities between 21 CFR 312 and 21 CFR 812.

As a resource to you, IMARC Research has published a whitepaper on this hot topic. Based on the feedback from this publication, as well as the many requests to train on this, we can tell this is an area where more information is desired.  Because of this, we want to emphasize the following resources available:

  • View the BioEnterprise training presentation
  • Part of the BioEnterprise talk focused on the FAIR Shake™ which is a technique that takes a complicated maze of requirements and breaks them down into four simple areas that can be applied to clinical research questions

If you are interested in learning more about the difference between drug and device clinical trials, please do not hesitate to contact us. We would be happy to assess your training needs and design a training program that fits your needs.

Photo Credit: wingedwolf

 Download Drugs vs. Devices

Topics: BioEnterprise, 21 CFR 812, FAIR Shake. Training Technique, 21 CFR 312


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