Compliance for Risk Based Approaches for (Clinical Trials 2018)

Wednesday, September 12 | 10:00 am - 11:00 am

Overview: 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 Consultants 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 Email:

Event Location

Event Location
  • Online
  • 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
  • Fremont
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