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 […]
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.
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 […]
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 […]
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!