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2018 - Compliance for Risk Based Approaches for (Clinical Trials 2018)



VenueFremont, USA - United States USA - United States

KeywordsClinical Research Associates; Affairs Specialists; Drug Safety


Topics/Call fo Papers

FDA and EMA have communicated their expectations for trial
oversight/ monitoring, monitoring systems, and investigative site
oversight. These are described in the FDA Guidance Oversight of
Clinical Investigations: A Risk- Based Approach to Monitoring and
the EMA Reflection Paper on risk-based quality management in
clinical trials both of which will be reviewed in this web seminar.
Why should you Attend:
This essential webseminar will explain the importance of using risk
management techniques in clinical research to comply with the
latest focus on GCP inspection in this area. It will show you how
risk management can improve the quality of your clinical trials and
demonstrate the importance of using risk analysis and risk
management techniques in clinical trials.
Areas Covered in the Session:
Have explained key risk based process/tools and techniques
Review a risk based approach to protocol design
Understand risk based approach to monitoring/data handling
Hear best practice of these new risk requirements
Who Will Benefit:
Clinical Development Managers and Personnel
Clinical Research Archiving and Document Management Personnel
Quality Assurance Managers and Auditors
Regulatory Affairs Specialists
Pharmacovigilance /Drug Safety
Study Site Personnel
Speaker Profile:
Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an
independent QA and training consultant in the pharmaceutical
industry. She is a managing director with LB Training and
Development Ltd., course director for the M.Sc. in Clinical
Research, School of Pharmacy at the University of Cardiff, and
course director for M.Sc. Regulatory Affairs, TOPRA.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

Last modified: 2018-07-09 18:04:41