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 […]
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 […]
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 […]
This is an excellent course taught by experts with real-life practical knowledge and experience in regulatory affairs. This course will strengthen your knowledge of EU regulatory procedures and regulatory requirements for marketing approvals. We will be covering the following topics* in this course: Common Technical Document Module 1: Administrative Information & Prescribing Information • Introduction […]
The main theme of the MEB College Day 2021 is 'Balance in troubled times'. The focus will be on the lessons learned during the corona pandemic. For example, for which therapeutic areas and indications in the future will MEB focus on accelerated assessments. The topics will include ethics, risk communication, and remote clinical trials. Digital […]
Please save the date for the RSNN annual workshop 2021. The workshop will take place on 23 November 2021 from 13:30-18:30 at the Jaarbeurs in Utrecht (in person). Program and speakers will be announced soon!
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.
