Li Ka Shing Center 291 Campus Drive
Palo Alto
CA 94305
Click HERE to Register!
The mission of the Stanford Center for Clinical Research (SCCR) includes offering educational resources, training, and support for investigators and research staff. We have invited highly-experienced educator in data integrity and risk-based monitoring training, Andrew Lawton, to provide you with an advanced training on the inspection findings after ICH E6 R2 implementation and a basic understanding of CRO oversight.
At the conclusion of this class, you will be able to:
- Identify the differences in approach to inspections by the FDA, EMA, PMDA (Japan) and MRHA(UK)
- Understand the expectations and drivers for each of the FDA, EMA, PMDA, and MRHA
- Outline the implementation of ICH E6 R2 by examining the inspection case studies
- Describe the inspection methods, sponsor preparation methods, and overall findings
- Define CRO oversight
- Recognize the use of the oversight in regulatory documents since 2011 (FDA, EMA, ICH, WHO) with examples of good oversight
- Explain the overall methodology of oversight
- Examine what has been done by sponsors and classed as oversight
- State what has been used in other industries
Registration for this course is through STARS, activity code SCCR-9000. The cost of the training is $100, and the course is STAP eligible. If you have any questions, please contact Kiera (Larsen) Davis at klarsen5@stanford.edu or Susan Saba at ssaba@stanford.edu.
About the Instructor:
Andrew Lawton has extensive experience in computing, statistics, data management, RDE/RDC, system design, Risk Based Approach in both CSV and clinical trials.
He is currently a consultant and director of Risk Based Approach Ltd and has worked with a variety of companies and institutions on the implementation of ICH E6 R2 and Risk Based Monitoring.
Previously, Andy held the position of Global Head of Clinical Data Management at Boehringer Ingelheim where he also held positions of increasing responsibility during his 32 years with BI. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream, and a Member of EFPIA WG on Data Transparency. His most notable publication is with Dr. Alistair Ross on GP Audit – throughout the 80’s and 90’s this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.
Board of Registered Nursing (BRN) OPTIONAL
Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 2 contact hour(s).
ATTENDANCE POLICY
In order to receive CEC credit for attending this workshop, you are required to attend the full 2.5-hour workshop. In an effort to respect others and our guest instructor, please make prior arrangements if you need to arrive late or leave early by contacting Kiera (Larsen) Davis.
CANCELLATION POLICY
If you can no longer attend and wish to drop the course, you can drop the course in STARS. You must drop the course at least 4 BUSINESS DAYS prior to the course to avoid being charged.
WHO CAN ATTEND THIS TRAINING?
This workshop is designed to provide training to any member of the research staff.