Tag Archive: pharmacovigilance

Jul 14 2011

Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, and many other global agencies. This year’s keynote speaker was the renowned AIDS researcher and …

Continue reading »

Jun 10 2011

Free Educational Webinar – New Rules in FDA Safety Reporting: Are You Prepared?

UPDATE: The slides from the webinar are now available for download here. Please join us on Wednesday, 15 June (10:00 AM EDT) as we focus on the FDA’s new rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,” which became …

Continue reading »

Jan 20 2011

Is it an Adverse Event or an Adverse Drug Reaction?

The ICH E6 guideline offers clear definitions for adverse events (AEs) and adverse drug reactions (ADRs). AEs are considered to be any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. ADRs, on the other hand, consist of …

Continue reading »

Oct 18 2010

RAPS Preconference Workshop – EU Regulatory Affairs Essentials

Image via Wikipedia The 2010 RAPS Annual Conference and Exhibition will be from Sunday, 24 October to Wednesday, 27 October at the McEnery Convention Center in San Jose, CA.  While  the “main event” kicks off on Monday, 25 October at 8:30 AM, you should make sure to be in town on Sunday, 24 October to …

Continue reading »

Jun 09 2010

FDA & NIH Launch Electronic Safety Reporting Portal

Biology will relate every human gene to the genes of other animals and bacteria, to this great chain of being. – Walter Gilbert The FDA and the NIH have announced a joint venture called the Safety Reporting Portal (SRP).  The SRP is a website for reporting safety data (pre- and post-market) in compliance with U.S. …

Continue reading »

Mar 12 2010

Cato at the SQA 26th Annual Meeting and Quality College

The Society of Quality Assurance (SQA) will be holding its 26th Annual Meeting and Quality College on 25-30 April 2010 in Cincinnati, OH.  Three days of plenary and concurrent sessions will explore hot topics and the latest regulatory interpretations in the field.   Sessions will focus on regulatory-based topics in manufacturing (GMPs), preclinical (GLPs) and clinical …

Continue reading »