Good Clinical Practice Workshop: Submitting Realistic Study Budgets
Speaker: Patty Kasper, MS
Date/Time: Wednesday, August 7, 9:00-11:00 am
This workshop will focus on the details related to submitting realistic study budgets, how and where to look for this information, and the rationales for supporting the requested costs.
Good Clinical Practice Workshop: ICH E6 R2 Inspection Findings & CRO Oversight
Speaker: William Andrew Lawton
Date/Time: Friday, September 6, 9:00-11:30 am
William Andrew Lawton, consultant at Risk Based Approach Ltd., will review the differences in approach to inspections by the FDA, EMA, PMDA (Japan) and MRHA (UK). He will present five case studies of inspections since the implementation of ICH E6 R2, examining inspection methods, sponsor preparation methods, and findings. CRO oversight will also be reviewed, including the definition of oversight and review of the term in regulatory documents since 2011 (FDA, EMA, ICH, WHO).
SCCR Science Series: Basics of Bone Marrow Transplant
Speaker: Kate Tierney, RN, PhD
Date/Time: Wednesday, September 11, 9:00-11:00 am
Kate Tierney, RN, PhD, a clinical nurse specialist in the Division of Bone Marrow Transplant, will give an introductory level presentationon the purpose, reasons, proper treatment, and preparation for BMT, as well as current research frontiers.
Good Clinical PracticeWorkshop
Date/Time: Friday, October 11, 9:00-11:00 am
Topic, speaker, location and other details to be announced.
SCCR Science Series: Obesity Prediabetes and Type 2 Diabetes
Speaker: Tracey McLaughlin, MD
Date/Time: Thursday, November 7, 9:00-10:30 am
Dr. McLaughlin is a professor of Medicine (Endocrinology) and is board-certified in Endocrinology, Diabetes, and Metabolism. Her clinical focus is on the diagnosis and treatment of Type 2 diabetes, and she conducts a number of clinical research studies related to obesity, insulin resistance, diabetes, and cardiovascular disease. She will present an introductory level presentation on prediabetes in the obese patient population and Type 2 diabetes.
Quarterly Brown Bag Series: Future Sessions
· Wednesday, September 25, 11:30 am-12:30 pm
· Wednesday, December 11, 11:30 am-12:30 pm
Topics, speakers, locations, and other details to be announced.