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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

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

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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September 2021

QDossier Presenting on FDA Drug Approval Process

September 20 - September 21

During this course, you will gain a deep understanding of the eCTD submission process for FDA drug approval. This program covers procedures for submission of INDs, NDAs, ANDAs, and 505(b)(2). It provides a useful insight into the organization and structure of the FDA and its review processes and highlights recent changes. The course is well structured and organized in 8 modules which helps the audience to understand the entire drug approval process in a continuous flow. Module 1: History and…

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October 2021

QDossier Presenting on Filing eCTD Submissions

October 20

Join us for this intensive one-day training course on filing eCTD submissions. This course will provide in-depth knowledge on components of eCTD and how to build a dossier right the first time using MS word templates. By getting insights from trainers who have vast experience in eCTD submissions, you will learn how to build, publish and deliver successful submissions across the EU and the US. An interactive case study session will provide practical knowledge and explore the challenges during eCTD…

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QDossier Presenting on Registration and Impact of SmPC on Market Access

October 22 @ 10:00 - 13:00
Baarn, Amalialaan 126b 3743 KJ Baarn
Baarn, Netherlands
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Regulatory approval does not ensure market access to a drug. Purchasing policy, reimbursement applications, and clinicians’ prescribing decisions are equally important to ensure drug accessibility to the patients. Marloes will present the first module of the NEW Smelt Academy market access program. In that module, she will focus on the EU registration process of human medicines. Thereby she will do a deep dive into the development process of an SmPC and discuss the important role that SmPC-wording has down the…

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