Compliance for Risk Based Approaches for (Clinical Trials 2018)

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: [email protected]

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WHEN AND WHERE

12 September 2018
United States of America

ORGANIZER

Netzealous LLC DBA - Compliance4All

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Added 5 years ago by Compliance4All on Health