Vendor/CRO Oversight of Clinical Trials Including Oversight Compliance During COVID-19

Why Should You Attend:

With regulatory inspectors increasingly finding issues with vendor oversight by sponsor organisations running clinical trials, it is becoming even more important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities. This is particularly important with the emerging coronavirus (COVID-19) situation which is increasingly impacting clinical trials including Vendor Oversight.

There are guidances from FDA, EMA and industry associations which provide recommendations for managing clinical trials and which impact on vendor oversight with emergency interim measures so that clinical trial oversight is maintained during this period to ensure that data quality is unaffected, clinical trial sites are supported and that the patients enrolled in clinical trials are kept safe.

This session will explain the key requirements for CRO oversight to comply with the latest focus on GCP inspection in this area including during the challenging environment of COVID-1

Learning Objectives:

• Understand the new requirements for Oversight in clinical trials including during Covid-19
• Define the regulations and guidelines which cover vendor oversight
• Review of risk-based approaches of vendor oversight for clinical trial projects
• Learn how to identify and evaluate vendor Oversight during COVID-19
• Consider how to implement oversight within your organization
• Best practice of these new vendor oversight requirements during COVID-19

Areas Covered in the Webinar:

• An overview of CRO Oversight requirements including during COVID-19
• CRO Oversight definition and scope
• Risk based methodology used in clinical research projects for vendor oversight
• Preparation, planning clarity of roles and responsibilities
• Measuring CRO performance including metrics and key performance indicator
• What documents should be in place to demonstrate CRO oversight to inspectors and auditors
• How to document vendor oversight during COVID -19

Who Will Benefit:

The session is relevant for professionals working in pharmaceutical, biotechnology, CRO, regulatory authorities and study sites including investigator-initiated studies involved in clinical trials. It will also be of interest to those departments who liaise/support clinical trial personnel such as:

• Clinical development managers and personnel
• Clinical operations professionals
• Clinical research associates
• Clinical research archiving and document management personnel
• Quality assurance managers and auditors
• CRO personnel
• Project management
• Sponsors and non-commercial sponsors
• Consultants
• Laboratories analysing samples from clinical trials
• Regulatory affairs personnel
• Legal and regulatory authorities
• Vendor management professionals

Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development

Dr Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management and risk based monitoring. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.

Dr Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management, and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).

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