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November 2019

Qdossier presenting at the Topra Autumn Introductory course 2019

5 November 2019 @ 08:00 - 8 November 2019 @ 16:00

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…

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February 2020

Qdossier Short Course at the RSIDM Forum

10 February 2020 @ 11:00 - 12 February 2020 @ 14:15

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…

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April 2020

Meet us at LorenzLink

21 April 2020 @ 08:00 - 22 April 2020 @ 15:15

LORENZlink is our industry-wide RIM forum in North America with a philosophy to Converge, Connect and Collaborate. The event brings LORENZ customers, partners and others interested in Regulatory Information Management together to network, share practical experiences and best practice know how on a wide range of topics impacting Regulatory Affairs Professionals. More information on the event can be found here.

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May 2020

Meet us at Amplexor’s Virtual Be The Expert 2020

27 May 2020 @ 08:00 - 29 May 2020 @ 17:00

BE THE EXPERT 2020 brings together leading subject matter experts and industry professionals from around the world into one forum to discuss and exchange strategies that combat the challenges in an ever-changing regulatory landscape. You will walk away with enhanced knowledge that will position you to achieve positive results and transform the processes and technology within your business environment. For the first time in 22 years, we are excited to announce that our annual BE THE EXPERT 2020 conference will be…

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June 2020

Meet us at Virtual DIA Europe

29 June 2020 @ 09:00 - 3 July 2020 @ 13:00

DIA EUROPE 2020 GOES VIRTUAL! We're pleased to announce that much of the invaluable content, communication and community that defines DIA Europe will still go on, in the digital realm. The lively panel presentations, insightful Q&A sessions, and deep community exchanges you've come to expect will be carried on, through DIA's digital technology. 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…

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September 2020

Meet us at Lorenz UserBridge

15 September 2020 @ 08:00 - 17 September 2020 @ 12:30

This annual conference attracts LORENZ customers, partners and other regulatory professionals for two and a half days of presentations, networking and exchange of ideas. Learn, discuss and interact with industry and agency professionals! More information on the event can be found here.

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February 2021

RSIDM 2021: Qdossier presenting on IDMP & Data Management

February 8 @ 10:00 - February 10 @ 16:15
Virtual

DIA’s Regulatory Submissions, Information, and Document Management Forum (RSIDM 2021) 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 Informatics Business, Regulatory Informatics 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…

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March 2021

Qdossier-Generis webinar: a pre-configured and validated hosted platform for data governance, document authoring, dossier compilation and dossier viewing

March 10 @ 16:00 - 17:00

REGISTER NOW (FOR FREE) This webinar is co-organized by Generis and Qdossier. The speakers will illustrate how the hosted platform offers a one-stop-shop for all you need in relation to (regulatory) data, document and dossier management. The platform will comprise Generis's CARA Life Science Platform(TM), a content management platform, configured and validated according to Qdossier's Best Practice; Qdossier's Dossplorer(TM) dossier/eCTD voewer amd Dosscriber(TM) eCTD templates; and an eCTD builder solution; along with Qdossier's services for user administration and change control…

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April 2021

Filing eCTD Submissions Training Course – Management Forum

April 13
Virtual

On April 13th, Maikel Bouman and Marloes van der Geer present a 1-day eCTD submission training course, which is part of the Management Forum training curriculum. During that training, they will give a general eCTD introduction and share the Qdossier best practices in relation to eCTD preparation, submission and lifecycle-management. This training will give participants not only the right level of knowledge to get started with eCTD submissions. In addition, it directly provides attendees with right practical advice on how…

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