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EVENT DATE
Aug 2016
M T W T F S S
01020304050607
EXPO DATE
Aug 2016
M T W T F S S
01020304050607

Venue


Online Event
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Type: Online Event

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

B2B

EVENT DESCRIPTION

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

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.

For more detail please click on this below link:

http://bit.ly/1XypB15

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

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.

EVENT CONTACTS


Compliance Global Inc
2754 80th Avenue
New Hyde Park, NY 11040
(516) 900-5515

EVENT DETAILS

Primary Industry:
Clinical Pharmacology
Other Industries:
Clinical Pharmacology, Professional Healthcare
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
Notes:
Show Owner:
Compliance Global Inc.
Sponsorship: Yes

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Show Owner
Compliance Global Inc.

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