Tag Archive: DIA

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 …

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Feb 23 2011

Free Webinar – FDA Review Process for eCTD Submissions

Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. That’s why GlobalSubmit and Cato Research are offering a free educational webinar on the FDA Review Process on Tuesday, 01 March at 3:00 PM ET.

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 …

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Aug 04 2010

GlobalSubmit Suite 2010 Beta Test

GlobalSubmit is hard at work on the next version of their software suite.  In addition to several improvements to both REVIEW™ and VALIDATE™, the next update will also include PUBLISH™, their long anticipated eCTD and RPS publishing tool.  As I’ve previously mentioned, I joined the GlobalSubmit team at DIA 2010 and was given a demonstration of …

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Jun 18 2010

DIA 2010 – Week in Review

The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location.  In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas of the Agency. As previously mentioned, Will Lee and I attended the meeting.  For those …

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Jun 14 2010

DIA’s 46th Annual Meeting

The DIA Annual Meeting is one of the premier events for professionals involved in the discovery, development, and lifecycle management of pharmaceuticals, medical devices, and related products. With 25 content-area tracks, 330 sessions and 20 tutorials, presentations are geared to attendees at all disciplines, works settings, and experience levels. This year’s meeting is being held …

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Jun 14 2010

DIA's 46th Annual Meeting

The DIA Annual Meeting is one of the premier events for professionals involved in the discovery, development, and lifecycle management of pharmaceuticals, medical devices, and related products. With 25 content-area tracks, 330 sessions and 20 tutorials, presentations are geared to attendees at all disciplines, works settings, and experience levels. This year’s meeting is being held …

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Feb 10 2010

Cato at the DIA Electronic Data Management Conference

The Drug Information Association (DIA) will be holding its 23rd Annual Conference for Electronic Document Management on 16-19 February 2010 in National Harbor, MD (Baltimore-Washington Metro Area). Cato Research Regulatory Scientist Sybille Sauter will be one of three speakers during the Authoring Global Content Management session on Friday, 19 February from 10:30 AM to 12:00 …

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