Short Courses*
Monday 6:00-8:30pm
(SC1) Project Management of CROs
Eric Morfin, MBA, PMP, Partner, Clinical Excellence Research Institute; Partner, Critical Skills, Inc.
Ultimately, the challenge facing pharmaceutical companies today is to pursue two seemingly incompatible goals: maintain or increase quality products while dramatically reducing costs and development lead times. In this course, participants will learn all the necessary material for identifying and selecting the right CRO for each segment of the research targeted for outsourcing. Sponsor personnel will learn the techniques required for successfully managing CROs and the shared responsibilities required from the sponsor and the service provider. CRO personnel will gain the full understanding of what is expected of them in the new drug development process. The following issues will be discussed: type and selection of CROs; how the FDA views CROs; sponsor responsibilities; drug development plans; overall outsourcing programs; study-specific designs and accountabilities; proposal evaluation; site visits to CROs; resolving deviations; contract negotiations and partnering with CROs; and FDA- and EMA-based interactions with CROs. Participants can expect to review:
- The pitfalls of the current sponsor/CRO/site relationships and what can be done to overcome them
- The new “Pharma” and the realities of “Virtual Trials”
- Components in architecting the appropriate outsourcing model “Cost vs. Price”
- Determining core capabilities in accordance with what works best globally rather than locally
Wednesday 6:00-8:30pm
(SC2) Quality-Systems Based Approaches to a GCP Auditing Program
Michael G. Duncan, Program Manager, Global Systems, Quality Assurance, Johnson & Johnson
Swati A. Tendolkar, B.Pharm, MT(ASCP), MS, Program Manager, Global System Quality Assurance, Johnson & Johnson
This course will provide a review of Quality Systems as applied through development of procedures to control, assure and improve the quality of data and records, as well as the quality and effectiveness of processes and activities related to the conduct and oversight of clinical research. For clinical trials, quality may apply to data (e.g., data are accurate and reliable) or processes (e.g., compliance with the study protocol and GCP; ensuring informed consent; adequate data handling and record-keeping). This session will review how quality is assured through the development and application of standard operating procedures (SOPs) that define responsibilities, specify records to be established and maintained, and specify methods and procedures to be used in carrying out study-related activities. The main focus of the session will be the review of practices for a quality system (e.g., monitoring programs, auditing programs, complaint handling systems) for periodically reviewing the adequacy of clinical trial activities and practices, and for revising such practices as needed so that data and process quality are maintained. Processes in the review will include:
- Study monitoring
- Protocol creation
- Protocol compliance
- Informed consent
- Investigator and staff qualifications
- Records
- Confidentiality/Privacy
- Randomization
- Third party oversight
Thursday 1:00-3:30pm
(SC3) Quality by Design: How to Apply It When Setting Up Your Trials
Ken Schiff, BA, MBA, Quality Risk Management Associates, LLC
Quality by Design (QbD) is currently the focus of both regulatory agencies: FDA in sponsorship with the Duke University Clinical Trials Transformation Initiative (CTTI) and the EMA. Both agencies are focusing on QbD in the reflection paper, “Risk-Based Management of Clinical Trials,” published in 2011. Industry as well as regulatory bodies have recognized the need and benefits of implementing a risk-based approach to quality management, and are currently gearing up to accommodate this. This course is a timely response to this trend and is designed to provide its participants with a strong conceptual foundation of the principles of Quality by Design with a clear focus on the application of these principles. Learning objectives include:
- Apply QbD to ensure the key questions in a trial are addressed
- Build quality at key points in the processes
- Implement a Quality by Design approach to aid decision making
- Understand how applying QbD will build the foundation for your trials’ operational aspects, e.g., monitoring and outsourcing
*Separate Registration Required