Implementing ICH E6 (R2) – Case Study

The Webinar will provide useful information on implementing policies and procedures in compliance with the applicable regulation. The risk analyses that should be considered across clinical trial systems and processes, and the tools that can be used by relevant operations and QA to manage and monitor identified risks.

Areas Covered in the Session :

  • Background of ICH E6 (R2) risk requirements
  • Implementation of procedures for assessing risk at several trial levels
  • Tools needed to assess and monitor risk
  • Communications required to assure oversight of risk throughout the lifecycle of a trial at all levels within an organisation

Who Should Attend:

  • Clinical Operations
  • QA Operations
  • Clinical Development staff

FDB3501

Michael Ramcharan

Michael Ramcharan (BSc, MSc, MRQA) has nearly years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations. His auditing experience has involved conducting a wide variety of audits in GPVP, GCP and GCLP, globally. He has also hosted and supported various Regulatory Authority Inspections (eg, MHRA, EMA, Local EU) in the GCP and GPV space.

Michael’s audit experience has also extended to successfully designing, implementing, and conducting Remote audits in the GPVP arena which has allowed companies to maintain strong oversight of their Local Operating Companies and Business Partners in countries where travel restrictions do not allow for on-site audit visits. He has also assisted companies in managing their Pharmacovigilance QA audit programs adopting a risk-based approach to help identify and prioritize audits.

Michael has also been involved in the Training and Mentoring of auditors, providing bespoke training catered specifically to an individual’s development needs, and his varied experience has proved very valuable in this area.

membership
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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance