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

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.