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Meet us at the GPRAS

Berlin Berlin

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 […]

Qdossier presenting on Common Technical Document Training Course

Virtual

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 […]

DIA 2022 Global Annual Meeting

chicago McCormick Place West 2301 South Indiana Avenue, Chicago

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.

Qdossier Presenting on Regulatory Strategies for Orphan Drugs

Virtual

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: […]

Qdossier presenting on the FDA Drug Approval Process

Virtual

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  […]

Qdossier presenting on Variations to Marketing Authorisations

Virtual

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 […]

Qdossier presenting on Regulatory Strategies for Orphan Drugs

Virtual

On September 26th, 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: […]

Qdossier presenting on the FDA drug approval process

Virtual

On October 10 and 11th, 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  […]

Qdossier presenting on Biosimilars

Virtual

On October 11 and 12th, Qdossier will present a 2-day training course which is part of the Management Forum training curriculum. The interactive course will cover the regulatory pathways and challenges for biosimilars in both the US and EU and the regulatory strategies and requirements for development of biosimilar products. During this training you will: Discuss global […]

Qdossier presenting on Variations to Marketing Authorisations

Virtual

On October 13 and 14th, 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 […]