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Qdossier webinar series
Closing the loop between data, documents and dossiers
Qdossier (free) webinar series
Closing the loop between data, documents and dossiers
Closing the loop between data, documents and dossiers in pharmaceutical drug development, that is what Qdossier stands for. But also, something we believe is a must-do for pharma companies to be ready for the future. Regulatory Affairs specialists (technical- and medical writers and regulatory operations particularly) play a key role in this ongoing transition from document-centric thinking to fully data-driven processes.
In this series of webinars, Qdossier colleagues will illustrate how data, documents and dossiers can be fully connected; and how closing the loop between the three leads to efficient and reliable life-cycle management of medicinal products. Additionally, our speakers will share insights on how these principles serve as THE basis for more automation in the field.
The role of regulatory professionals is about to change. And we will explain you why.
Data governance
Jan 25th, 4-5 pm CET
by Hans van Bruggen
Data governance at the hearth of enterprise information management
Our speaker will set the scene on how data is at the heart of enterprise information. This webinar starts with explaining a way of thinking, whereby one focuses on how content can be separated from context. Followed by more in-depth information regarding aspects like master data, reference data and transactional data.
eCTD document templates
Feb 2nd , 4-5 pm CET
by Joyce van Gerven
eCTD document templates allowing for automatic content generation
This webinar aims to illustrate how automatic creation of regulatory documents using (xml) tags, filled from your company’s (IDMP) databases, leads to lean authored documents ready for reuse across products, countries and dossier types. Consistent use of terms and data, formulating clear statements and firm justification, leaves less room for misinterpretations and unnecessary questions from internal reviewers and external regulators.
Document re-purposing
Feb 17th, 4-5 pm CET
by Maikel Bouman
Re-purposing documents by placing it in the right context through dossiers
eCTD more and more became the mandatory, evolving standard for exchanging your regulatory documents with health authorities across the globe. This webinar aims to illustrate the benefits of correct document lifecycle and efficient reusability of documents in context of your dossier.
Master data management
Feb 22nd, 4-5 pm CET
by Michiel Stam
Managing master data in relation to authorized products
In the ideal situation the authorized product details are a reflection of the master data defined at the enterprise level. In reality MAH’s have to manage deviations across products and countries as a result of the outcome of regulatory procedure. Real life examples on how to manage these descrepancies successfully will be shared.
Sign up for the Qdossier Webinar series. Fill in your data and select which of the four webinars you would like to attend. You can select more than one webinar.
Please note: these webinars are in English and are dedicated to pharmaceutical companies