Reporting Adverse Event - Regulatory Requirements

This training program will offer attendees an understanding of the adverse event (AE) terminology and the role of Investigational Review Boards in the reporting process. It will also discuss the importance of the FDA’s post-approval risk assessment system and the pre and post-marketing AE reporting requirements worldwide.

Why Should You Attend:

Before the celebration of a successful clinical development of a novel therapeutic molecule, the teams face several years of challenges with the drug development process. In early drug development when just an idea has been placed on a path to clinical development the project team identifies the possible risk associated with that class of drug. 

Who Will Benefit:

Clinical Researchers

Laboratory Compliance Personnel

Medical Affairs Staff

Biotechnology and Pharmaceutical Managers and Directors

Risk/Compliance Officer in Clinical Fields

Healthcare Workers – Nursing and Monitoring Staff

Instructor Profile:

Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both academia and biopharmaceutical industry. During his prestigious career the focus of Mr. Thibodeaux’s research efforts has been on the efficacy of cardiovascular drugs most notably hypertension, myocardial infarction, focal ischemia (stroke), beyond advair pulmonary research and topical antibiotics.

Note:

Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.

For Registration:

http://www.complianceonline.com/reporting-adverse-event-regulatory-requirements-webinar-training-704203-prdw?channel=sciencedz