Risk-Based Monitoring in Clinical Investigations
October 29, 2012 | ARCHIVE NOW AVAILABLE!
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.
The webinar should not be missed. Risk-Based Monitoring is here to stay.
This webinar will address the following issues:
· How companies are putting FDA guidelines for risk-based monitoring into practice
· Best practices, pitfalls and challenges
· How much monitoring of clinical trial sites is really necessary to ensure quality, compliance and safety of research participants
Stanley E. Reaves Jr. RCIS, CCRP, Senior Clinical Research Associate, Abbott Vascular
Stanley Reaves is a US Army trained cardiovascular (CV) technologist with 23 years in the cardiology and endovascular field of medicine. Stan 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. After being honorably discharged from the Army, Stan and his family (wife– Dana, Son’s—Stan III and Austin) moved to Atlanta where Stan was employed as a staff technologist at Georgia Baptist Medical Center. Stan has worked in and managed cath labs in the Atlanta area and left the cath lab to join Abbott Vascular (AV) approximately 7 years ago as a Field Clinical Research Associate (FCRA). Stan did his undergraduate at the Stetson school of business at Mercer University where he graduated in December of 2000 with a Batchelor in BA and a minor in IT.
Stan 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…). Stan 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and project managers that developed what AV would term the Enhanced Monitoring Initiative in response to the FDA’s draft guidance on “Risk Based Monitoring” for Sponsors. Stan was invited to share AV’s experience as a major sponsor at the Barnett “Mastering Clinical Trials Conference” earlier this year. Stan and the Enhanced monitoring team within AV still meet on an ongoing basis to develop and refine tools for their organization as well as discuss the challenges that surface from time to time as a result of implementing an Enhanced monitoring program. Over the life cycle of several trials, AV expects to ensure subject safety as well as provide quality data while significantly reducing the cost associated with on-site visits and the travel costs associated with these visits.
|Date: October 29, 2012
Time: ARCHIVE AVAILABLE!
|Professionals from pharmaceutical, biotechnology and medical device companies with responsibilities and interests in the following areas:
- Clinical Research Coordinators
- Clinical Project Managers
- Clinical Research Associates / Monitors
- Clinical Research Managers
- Site Administrators
- Clinical Quality
- Quality Assurance
- Clinical Monitoring
- Clinical Operations
- Clinical Compliance
- Monitoring Operations
Terms and Conditions
Registration provides individual access to the live webinar and/or to the recording of the presentation. If a webinar is postponed due to unforeseen circumstances, the registrant is entitled to attend the rescheduled webinar or to receive a credit for a future webinar
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