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Tag Archives: marketing application
Download the Slides from the Data Quality and Integrity Webinar
Yesterday’s free webinar, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval,” was a great success! For those who would like them, the slides from the presentation are now available for download here (PDF file). Stayed tuned Ask-Cato.com for … Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged Cato Research, clinical study report, clinical trials, data standards, drug development, marketing application, regulatory affairs, webinar
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Data Quality and Integrity: From Clinical Monitoring to Marketing Approval
At 2:00 PM ET on Thursday 18 November 2010, Cato Research will host a webinar titled, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval.” The webinar will be presented by Nancy Detich, Ph.D., a Senior Clinical Strategy Scientist … Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged Cato Research, clinical study report, clinical trials, data standards, drug development, marketing application, regulatory affairs, webinar
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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 … Continue reading
Posted in Conferences and Meetings, Regulatory Strategy
Tagged Cato Research, conference, EU, marketing application, pharmacovigilance, RAPS, regulatory affairs
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OIG Report Shows Increasing Use of Foreign Clinical Trials in Marketing Applications (and Challenges for the FDA)
There are no foreign lands. It is the traveler only who is foreign. – Robert Louis Stevenson Global. That’s one of the buzz words/ideas that has gripped modern drug development. In particular, there is a notion that foreign countries represent … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged biologics, BLA, clinical trials, drug development, FDA, GCP, IND, inspections, marketing application, NDA
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Switching from Paper to eCTD Submissions
Despite the many advantages of eCTD submissions, many smaller companies may still be reluctant to take the leap. Concerns over the costs of implementing an eCTD publishing system and the lack of in-house expertise are often the primary stumbling blocks. … Continue reading
Posted in eCTD
Tagged bookmarks, CFR Part 11, CMC, eCTD, Electronic Submissions Gateway, ESG, hyperlinks, IND, marketing application, NDA
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