Compliance for Risk Based Approaches for Clinical Trials


Wednesday, September 12, 2018   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 60 Minutes      

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Duration: 60 Minutes  

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This essential webinar 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.
Laura Brown   Product Id : 502073
  Instructor : Laura Brown

  More Trainings by this Expert


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: Risk management is becoming increasingly important to running clinical trials. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, the revised ICH GCP R2 guideline, the revised EU Clinical Trial Regulation guideline on risk management and several other risk management clinical research standards and initiatives.

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.

You will learn how to identify, evaluate and also how to implement specific risk-based techniques for risk management used in clinical trials.

Areas Covered in the Session:

  • Understand the new requirements for risk management in clinical trials
  • Define the regulations and guidelines which cover risk management applied to clinical study-level risk management
  • Consider the elements of QM system are and what a regulatory inspector would expect to be in place for clinical trials
  • 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 Research Associates (CRAs)
  • Monitors
  • Clinical Managers
  • Project Managers
  • Lead Clinical Research Associates
  • Data Managers and Statisticians
  • Study Managers, Document Management
  • 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. Dr. Brown has 20 years experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy.

She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International. Dr. Brown has published material on the new EU Clinical Trial Regulation and also a practical guide to the current regulatory requirements for carrying out clinical trials in the EU. She has penned a chapter on training QA staff in the leading GXP book “Good Clinical, Laboratory and Manufacturing Practices” (2007). She has authored SCRIP’s latest GCP guide and one entitled “Practical Guide to the Clinical Trial Directive”. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and in training courses on QA and GXP issues.

Dr. Brown developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (a regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013). She runs many training courses on topics such as: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, regulatory requirements for clinical trials, the clinical trial directive, managing clinical trials, QA management and business skills, how to prepare for audit and inspection, how to audit, etc.




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