Regulatory Affairs: The Big Picture
Realistic regulatory focal points for research professionals
Free Webinar: July 20th, 2017 1:00 PM EST
Regulatory affairs can be complicated, as many FDA guidelines are just that – guidelines. As site personnel, we always come across unique scenarios and oftentimes it is tough to figure out appropriate responses while striving to maintain regulatory compliance, especially when the guidelines can be vague!
In this webinar, we break down the IRB submission process and discuss several unique scenarios and how to approach them at the site level. We also will go over other important aspects of regulatory affairs, including maintenance of a study regulatory binder and how to address protocol deviations.
During this webinar, presenter Kasi Bettencourt of BTC Network will discuss:
- Initial regulatory packet focal points
- Determining deviations and reporting correctly
- Preventing common regulatory mistakes
- IRB annual and ending reports
This webinar was recorded on July 20, 2017. The full recording is available on demand.
About the Presenter:
Kasi J. Bettencourt CCRP
Project Director at BTC Network.
Kasi has more than 9 years of clinical trial research experience providing managerial leadership in site functions, monitoring, training, regulatory affairs, project management, and study coordination. She joined our team of professionals after spending many years working on the sponsoring side of the research spectrum in South Florida. Kasi’s vast knowledge into the interworking of running trials from a sponsoring perspective makes her a tremendous asset to our team and the best possible person to give you the tips of the trade.