Serious Adverse Events 2016 - What is a Serious Adverse Events and how do I handle these - By Compliance Global Inc

Overview:
Serious adverse events along with their cousins, serious adverse reactions, anticipated events, unanticipated events and unanticipated problems are often confused and misunderstood.
Why Should You Attend:
Regulations and guidance can be overwhelming and seem conflicting when it comes to handling serious adverse events.
Areas Covered in this Webinar:
This webinar on serious adverse events, will show you why it is important to know when and what needs to be submitted, reviewed, and approved by an Institutional Review Board (IRB) and what can be handled by the investigator as non-reporting of events that are considered reportable can lead to issues related to non-compliance.
Learning Objectives:
ICH guidelines and Good Clinical Practice (GCP)
Department of Health and Human Services (DHHS) guidance
Food and Drug Administration (FDA) guidance
Definitions
Potential effects on consent and the protocol
Who Will Benefit:
Human Subjects Research Personnel
Clinical Research Personnel
New Clinical Research Coordinators
New Principal Investigator Positions
Administration in charge of Clinical Research
Regulatory Compliance Personnel
For more information, please visit : https://complianceglobal.us/product/700423/SarahFo...
Email: support-AT-complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile:
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program.
She has initiated the planning, development, authorship and implementation of many human subjects’ research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students.
More recently, she led a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook. Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.