Compliance with the New ICH GCP Revision 2 Addendum - Know the How?


Monday, April 1, 2019   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 60 Minutes          

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This informative session will cover these new requirements for auditing clinical trials, evaluate the changes and understand how these impact on auditors, This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally.

Laura Brown   Product Id : 502387
  Instructor : Laura Brown

  More Trainings by this Expert


Overview:

This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites.

This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally.

Why should you Attend: With the new ICH GCP E6 Revision 2 Addendum now finalised the changes should have been implemented for organisations running clinical trials.

The new guideline includes a number of "hot" GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials.

It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection.

The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year.

This informative session will cover these new requirements for auditing clinical trials, evaluate the changes and understand how these impact on auditors.

This will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.

Areas Covered in the Session:

  • Understand the new requirements of the updated ICH GCP R2 guideline
  • Ensure best practice with implementing the new requirements
  • Review the new requirements for Sponsor and Investigator Oversight
  • Understand requirements for CROs, quality systems
  • Explore risk based approaches for clinical trials
  • Consider changes for the TMF
  • Best practice for Clinical QMS
  • Review best practice of these additional new ICH GCP R2 requirements

Learning Objectives :
  • Clinical QMS implementation
  • Implications of New definitions or enhancements to existing glossary terms
  • Understand the requirements for quality systems with a risk based approach
  • Consider how information should be recorded, handled and stored and compliance with data integrity expectations of inspectors
  • Review Clinical investigators’ qualification requirements, supervision responsibilities, record keeping and reporting
  • An increased focus on risk-based monitoring
  • CAPA requirements
  • Ensuring vendor oversight meets the expectations of inspectors
  • And much more

Who Will Benefit:
  • Director of Publications
  • Director of Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers
  • Compliance Staff
  • Clinical Quality Auditors
  • Quality Assurance Personnel
  • Document management
  • CRO
  • Auditors
  • QA Professionals
  • Regulatory Affairs
  • Pharmacovigilance in Pharmaceutical,Biotechnology


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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