Toronto, Canada (PRWEB) October 26, 2012
In the absence of clear rules and guidelines from the FDA and EMA, companies are left trying to determine exactly what an effective and compliant risk-based monitoring program should look like. This webinar will not only leave you with a clearer understanding, from a Big Pharma company, on how to establish such a program, but can also provide ways in which you will be able to fine-tune your existing program. This webinar should not be missed. Risk-Based Monitoring is here to stay.
Join us on October 29th to learn more about Risk- Based Monitoring in Clinical Investigations.
Our keynote speaker, Stanley E. Reaves Jr., RCIS, CCRP, Senior Clinical Research Associate, Abbott Vascular will cover:
- How companies are putting FDA guidelines for risk-based monitoring into practice
- Best practices, pitfalls and challenges
- How much monitoring of clinical trials sites is really necessary to ensure quality, compliance and safety of research participants
A live Q&A with the audience will follow the presentation.
Stanley E. Reeves is a US Army trained cardiovascular (CV) technologist with 23 years in the cardiology and endovascular field of medicine. Stanley received his CV training at Ft. Sam Houston in San Antonio, TX and remained as an instructor at US Army School of Cardiovascular Technology for 3 years. Stanley now has 7 years of experience in Medical Device Clinical Research and is currently a Senior FCRA with AV where he routinely performs all of the responsibilities of the Senior FCRA (monitoring, case proctoring, FDA inspection Prep, etc…). Stanley was part of a multidisciplinary group of CRA’s, Data Managers, and project managers that developed what AV would term the Enhanced Monitoring Initiative in response to the FDA’s draft guidance on “Risk Based Monitoring” for Sponsors.
Stanley did his undergraduate at the Stetson school of business at Mercer University where he graduated in December of 2000 with a Bachelor in BA and a minor in IT.
To register for this event go to: http://xtks.in/XTGWRV
Zayeeta Dasgupta, M.Sc in Life Science and Business Management
(416) 977-6555 ext. 260
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