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Tag Archives: DIA
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, … Continue reading
Posted in Uncategorized
Tagged AIDS, biologics, biosimilar, Cato Research, CBER, CDER, clinical trials, DIA, EMA, EU, FDA, follow-on biologics, generic drugs, geriatric, GMP, guidance, HIV, marketing application, oncology, Orphan Drug Designations, pediatric, pharmacovigilance, pre-IND
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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. Continue reading
Posted in eCTD, Regulatory Strategy, Webinars
Tagged Cato Research, DIA, eCTD, FDA, GlobalSubmit, RAPS, rev, submissions, webinar
2 Comments
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 … Continue reading
Posted in Clinical Trials
Tagged adverse drug reactions, adverse events, clinical trials, DIA, pharmacovigilance, safety
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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 … Continue reading
Posted in eCTD, Industry News
Tagged DIA, eCTD, FDA, GlobalSubmit, Health Canada, quality control, RPS, webinar
2 Comments
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 … Continue reading
Posted in Conferences and Meetings, eCTD, FDA
Tagged adverse events, biomarkers, biotech, cell therapy, clinical development, clinical trials, CMC, comparative effectiveness, data standards, DIA, eCTD, FDA, globalization, in vitro diagnostics, personalized medicine, pharmacokinetics, Phase 1, Phase 2, RPS, study tagging files, transparency
2 Comments
