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November 2019
Qdossier presenting at the Topra Autumn Introductory course 2019
The Topra Annual Autumn Introductory course is a comprehensive 4-day introduction to EU Pharmaceutical Regulatory Affairs. Hans van Bruggen (Qdossier) will be presenting on various topics. Common Technical Document Module 1: Administrative Information & Prescribing Information Introduction to CTD Overview of Module 1 Type of application (including abridged applications) Summary of Product Characteristics (SmPC) Application form including appendices PIL user testing EU regional requirements e-Submissions Regulatory guidance leading to eCTD Prerequisites for proper eCTD usage Other e-submission initiatives including PIM…
Find out more »February 2020
Qdossier Short Course at the RSIDM Forum
DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum brings together industry and regulatory stakeholders working across the scope of regulatory information to examine current data standards and requirements and effective regulatory information management approaches to align related systems. The Forum presents four tracks: Regulatory Information Management (RIM) Business, RIM Technology, Electronic Document Management, and Electronic Regulatory Submissions. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory information, and plenary sessions featuring regulatory intelligence updates by…
Find out more »March 2020
Meet us at DIA Europe
DIA Europe is a must-attend event for life science professionals from across the entire drug development spectrum - from discovery to marketed use – to facilitate open collaboration by incorporating representatives from the full life sciences landscape. Thought-provoking, worldwide issues will be deconstructed by acclaimed panelists representing multiple stakeholders from around the world in this growing ecosystem of life sciences. More information about the conference can be found here.
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