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 […]
Join us in an interactive two-day course that will provide you with a clear and comprehensive understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of the EU and USA. Furthermore, the course examines the requirements for global roll-out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories. You will increase your […]
At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM 2022) Forum, we will hear from industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related systems. The Forum presents four tracks: 1. Regulatory Informatics Business 2. […]
One of our Qdossier members (Marloes van der Geer) will be attending the DIA Europe meeting, taking place in Brussels this year. In case you are interested to meet someone from Qdossier at the DIA Euromeeting, please just reach out via info@qdossier.com and we will make sure to connect.
On 6-8 April Dossplorer will have a booth at the Global Pharmaceutical Regulatory Affairs Summit (GPRAS) in Berlin, Germany where you can see our solution and ask all of your questions. Also two of our Qdossier members (Hans van Bruggen and Marloes van der Geer) will be joining the conference and they would love to […]
Join us in an interactive two-day course that will provide you with a clear and comprehensive understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of the EU and USA. Furthermore, the course examines the requirements for global roll-out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories. You will increase your […]
Our CEO Hans van Bruggen will be attending the DIA Global Annual Meeting, taking place in Chicago this year. If you want to know about our services and how we can help you navigate through complex challenges of regulatory affairs/operations, please reach out via info@qdossier.com and we will make sure to connect.
On June 20th, Qdossier will present a 1-day training course which is part of the Management Forum training curriculum. The interactive course will cover all the key aspects of orphan drug legislation in both the US and EU and the regulatory strategies/processes designed to enable early access to innovative medicines. During this training you will: […]
On June 27 and 28th, Qdossier will present a 2-day training course which is part of the Management Forum training curriculum. The interactive course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments. During this training […]
On July 7 and 8th, Qdossier will present a 2-day training course which is part of the Management Forum training curriculum. The 2-day event will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures. During this training you […]
