Accurate Adverse Event Reporting is the Key to Subject

Safety of Approved Drugs

Tuesday, Apr 14, 2015 01:00 PM EST, Duration: 90 min, Course Level: Intermediate

Webinar by Charles H. Pierce

Overview

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. To accurately and astutely see and report AE‟s is the primary function of the PI. Why should you attend?

With the increasing complexity of the Investigational Medicinal Products (IMP‟s), it behoves all who have any role in observing Study Participants to know the importance of accurately collecting all AE and SAE data. 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. 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. Areas covered in the session

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

Learning objectives

Describe what AEs are and what they are not.

Define „Reportable Events‟ & how to report them.

To know the importance of knowing the Risk a medication places on a population and the new Risk Evaluation and Mitigation Strategies

Understand The commonality of Pre-market and Post market Adverse Event reporting and the different terms and programs

Discover the most common Reporting Errors. Who will benefit

Pharmaceutical, Biological and device companies with an active pipeline of

products and planning on global studies Principal Investigators and sub

investigators

Clinical Research Scientists (PKs, Biostatisticians) Research managers

Safety Nurses

Clinical Research Associates and Coordinators

Recruiting staff

QA / QC auditors and staff

Study Monitors

Clinical Research Data managers

Instructor profile

Charles H. Pierce, MD, PhD, FCP, CPI Has 25+ years experience in the

Clinical Research field. He now brings the message (via webinars, lectures

and seminars) of Risk Management through knowledge 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. He 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