Adverse Event Reporting Compliance; The Key to Safe Drug Development / Subject Safety

Duration: 90 Minutes
The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects.
Drug Discovery And Development
Product ID: 500242

AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge. To obtain 'commonality' in reporting, investigative sites require familiarity with one of the Adverse Event Terminology systems. As codified in 21 CFR 312.64(b), an investigator shall promptly report to the sponsor any adverse event that may reasonably be regarded as caused by, or probably caused by, the drug.

See Why determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment).

Without a doubt or question, accurate collecting and reporting of Adverse Events (AE’s) is really the single most important function of the Investigational team as far as Subject safety is concerned.

Why Should you Attend:
With the increasing complexity of the Investigational Medicinal Products (IMP’s), it behooves all who have any role in observing Study Participants to know the importance of accurately collecting all AE and SAE data.

Objectives of the Presentation:
  • The definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more
  • How to know what an Adverse Event is and when to report it or them
  • Knowing the AE types and likelihood of finding “rare” events
  • Understanding laboratory AEs and the "Reference Range" concept
  • Common Mistakes in AE / SAE Reporting
  • Reporting of Adverse Events - when and to whom and the use of AE Terminology systems
  • How to record Adverse Events and assess causality - the algorithm
Who can Benefit:
This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
  • Principal Investigators
  • Sub Investigators
  • Clinical Research Scientists (PKs, Biostatisticians, ...)
  • Safety Nurses
  • Clinical Research Associates (CRAs)
  • Clinical Research Coordinators (CRCs)
  • QA / QC auditors and staff
  • Clinical Research Data managers
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Charles H Pierce is President of the virtual CRO Global Clinical Partners, Inc and Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification’s to 2016). He is actively involved in Webinars, courses and workshops.

Charles’ active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU’s). Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU). He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).
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