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Compliance for Risk Based Approaches for (Clinical Trials 2018)

From Wednesday, September, 12, 2018 to Wednesday, September, 12, 2018 in CA
Starting from:10:00
Concerned sectors: Medical Informatics -Public Health -
DESCRIPTION
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: support@compliance4All.com
PUBLIC, SECTORS, ACCREDITATION
Accreditations: 0
Concerned Public: Professional
Attendance: International
Visitors/Participants: 50
Speakers: 1
Exhibitor: n.c
Event Type: Online Conference
Major Sector: MEDICAL INFORMATICS
Concerned sectors: Medical Informatics -Public Health -
ORGANIZER / ADVERTISER

COMPLIANCE4ALL
161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congress, conferences or medical training REF #28-8252
Compliance for Risk Based Approaches for (Clinical Trials 2018)
Published on congres-medical.com on:2018-07-30 11:54:42
Congress, conferences or medical training in MEDICAL INFORMATICS
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