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.
- ICH guidelines and Good Clinical Practice (GCP)
- Department of Health and Human Services (DHHS) guidance
- Food and Drug Administration (FDA) guidance
- 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
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.
For more detail please click on this below link:
Toll Free: +1-844-746-4244
There may be many networking opportunities at the What is a Serious Adverse Events and how do I handle these? - By Compliance Global Inc.. Find out more in the event details below.
|Conference/Event Dates:||08/02/2016 - 08/02/2016|
|Primary Industry:||Clinical Pharmacology|
|Other Industries:||Clinical Pharmacology, Professional Healthcare|
|Cost to Attend:||Live Session for one participant Price: $165.00|
|Audience:||Human Subjects Research Personnel
Clinical Research Personnel
New Clinical Research Coordinators
New Principal Investigator Positions
Administration in charge of Clinical Research
Regulatory Compliance Personnel
|Show Owner:||Compliance Global Inc.|
|Sponsorship Details:||Compliance Global Inc.|
|Booth Size||Booth Cost||Available Amenities|
|Marketing Vehicles Allowed:||n/a|
|Other Booth Sizes Available: n/a|
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