ComplianceOnline

Why is Accurate Adverse Event Reporting essential for drug safety - How to Assess the Causality Relationship

Instructor: Charles H Pierce
Product ID: 701346
  • Duration: 90 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2009

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Clinical research training will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product research involving human subjects.

The principal objective in a new drug development program is to assess the benefit / risk ratio. Therefore risk information must be collected, documented and reported accurately. 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. 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 such as MedDRA. 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. Determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment).

Areas Covered in the seminar:

  • The CFR 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.
  • Understanding laboratory AEs and the "Reference Range" concept.
  • Type A and Type B Adverse Reactions.
  • How to record Adverse Events and assess causality - the algorithm.
  • Common Mistakes in AE / SAE Reporting.
  • The Role of Data safety monitoring in Protecting Human Volunteers.
  • Reporting of Adverse Events - when and to whom and the use of Adverse Event Terminology systems.

Who will 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) and Coordinators (CRCs).
  • QA / QC auditors and staff.
  • Clinical Research Data managers

Instructor Profile:
Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations, sits on University and industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been in the Clinical Research Industry for 19 years, has authored a "Manual for Investigators", and has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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