Roll up your sleeves for a two-day, introductory workshop on how to prepare an effective electronic Common Technical Document (eCTD) submission. This in-person workshop includes skill-building, interactive exercises, case studies and small group discussions.
Improve how effectively you network and advocate for yourself with ideas and techniques from this on-demand webcast.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
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A look at the blended approach and other options for an
outsourced pharmacovigilance model and their benefits for small pharmaceutical
companies. This article provides advice on the steps required to complete a
successful PV outsourcing project.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
India’s Drugs Technical Advisory Board (DTAB) has recommended granting Phase III clinical trial waiver to some drugs approved in "well-regulated" countries like the US or EU.
Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.