SCCR Virtual GCP Workshop: Adverse Events Management in Clinical Drug Trials

Presenter: Maya Berdichesky, DMD

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 Clinical Quality and Compliance manager, Maya Berdichesky, DMD, to present on the important topic of adverse events (AEs) in clinical research, how it must be documented and tracked, and, under certain conditions reported to Sponsors, regulatory agencies, and IRBs. In this talk you will learn about prompt and proper management of adverse events (AEs) and serious AEs (SAEs) that are encountered in human subject research with drugs. You will also get to put this learning to practice with case studies.

At the conclusion of this class, you will be able to:

• Identify adverse events and adverse events classification
• Explain the Stakeholder responsibilities
• Recognize the Information flow
• Understand the Reporting timelines
• Discuss Case studies

Attendance is open to all research staff

About the Instructor:

Until recently, Maya Berdichesky, DMD, has been the Quality and Compliance Manager at the Stanford Center for Clinical Research (SCCR), where she has been crafting and leading the center’s quality and compliance program for the past 5 years. Maya has been involved in clinical research for over 10 years, after making a career change from dentistry. Her research career at Stanford began six years ago when she accepted a Regulatory position with the Stanford Pain Division. Maya has recently taken on a new role with the Stanford Research Office, as the CTSA Hub Liaison Manager.

BRN OPTIONAL

Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 2 contact hour(s).
To receive your certificate with BRN credit, you are required to complete an evaluation at the conclusion of this class.
BRN Cancellation Policy: If you wish to cancel your registration, please contact Susan Saba at ssaba@stanford.edu.