Risk management practices are now expected to be incorporated into the clinical quality system of all clinical research stakeholders. This includes procedures for selection and oversight of CROs and other vendors. Every process - from vendor selection and establishing preferred vendor programs, to study project reports, communication plans, and project escalation - requires a high degree of risk-based diligence to satisfy regulators.
The establishment of clear roles and responsibilities within & between CRO and sponsor on who assesses monitors and documents risk management activities is critical to both compliance and success. Establishing effective communication plans for risk analysis and action plan responsibilities is of paramount importance in preventing problems and ensuring audit readiness.
Learning Objectives:
With Regulatory Inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming increasingly important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities. A company's ability to identify and select the right CRO / vendor for the right project and manage them efficiently and effectively will help to ensure compliance with the Regulator's expectations.
In this course you will learn:
How to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R & D projects you need to outsource. This course also covers the techniques for successfully managing CROs / vendors and the shared responsibilities required by the sponsor and the service provider. Managing CRO performance issues will also be discussed.
Why Should You Attend:
It is essential for industry to employ efficient and accurate strategies for monitoring outsourced clinical trials to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, and quality monitoring and risk minimization when outsourcing clinical trials to remain compliant.
Using a combination of theory and practical examples, this interactive course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge you need to ensure quality oversight.
Topics
- Understand how to effectively manage CROs / vendors used in the pharmaceutical industry
- Build an understanding of your responsibilities as the sponsor or the vendor: identifying the right level of oversight
- Discover tools and processes to manage CROs and other vendors
- Gain an insight for CROs/other vendors of what sponsors expect and how to meet their expectations
- Measuring CRO performance including metrics and key performance indicators
Instructor
Laura Brown, PhD, MBA, Diploma Clinical Sciences is an independent QA and Training Consultant in the Pharmaceutical Industry, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20year's experience of running clinical trials and clinical quality assurance in the pharmaceutical industry.
Laura Brown has held a number of international and senior management QA positions in the pharmaceutical industry including as an Associate Director with a leading GCP audit consultancy. She has worked for several international companies including GSK, Hoechst Marion Roussel and Phoenix International.
Laura is author of a chapter on "Training QA staff" in the leading GXP book: "Good Clinical, Laboratory and Manufacturing Practices". She is author of SCRIP's latest GCP guide and a "Practical Guide to the Clinical Trial Directive, a chapter on International Drug Development, Impact of Brexit, and several articles on the new EU Clinical Trails Regulation. 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 on training courses on QA and GCP issues.
Laura developed an e-learning module: "How to Prepare for Audit and Inspection" for Zenosis (A regulatory commercial e-learning training organization) and an e-learning GXP SOP series for Henry Stewart Conferences.
Laura runs many training courses both on public courses and in-company on topics including: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, clinical trial regulations, the new ICH GCP R2 guideline, managing clinical trials, QA Management and business skills, how to prepare for audit and inspection.