International Workshop Health Economics and Pharmacoeconomics (Postdam)

Scenarium in cooperation with Fundisa - African Academy of Medicine Development, supported by GHA-German Health Alliance as well as other prominent partners are organising the first edition of an international workshop on Health Economics and Pharmacoeconomics: Opportunities for German-African Cooperation October 30-31, 2021 hybrid event The workshop will take place simultaniously at University of Potsdam, […]

Annual workshop about lessons learnt (UNICOM NCAs)

This is a closed event. We already had presentation from a number of partners and this time we kindly invite: - BfARM (DE) - ARMPS (BE) - INFARMED (PT) to present lessons learnt from their view. We also invite ALL partners to share experiencies during the discussion.

Recurring

WP2 to present at IRISS meeting

Virtual

Monthly IRISS meeting IRISS is a non-profit dedicated to advancing Implementation of Regulatory Information and Submission Standards for life sciences globally, see https://iriss-forum.org/.

Second UNICOM Trans-Atlantic Workshop

The UNICOM Trans-Atlantic meeting will be officially coordinated by *CTADHL, a UNICOM partner formally tasked for trans-Atlantic outreach by UNICOM to include promotion and adoption of ISO IDMP across the medicinal product lifecycle. Although UNICOM is an EU initiative, it strongly considers collaboration and exchange with North American stakeholders as part of its remit to […]

Recurring

WP2 to present at IRISS meeting

Virtual

Monthly IRISS meeting IRISS is a non-profit dedicated to advancing Implementation of Regulatory Information and Submission Standards for life sciences globally, see https://iriss-forum.org/.

Training workshop on FHIR for NCAs

This event is open to ALL National Competent Authoritities; If you have not received an invitation, send a request to the follwoing email adress: WP4  kindly invites you to the follow-up training based on the concept presentation we had last year. We will prepare a FHIR example. We will use EMA's LOSEC example as […]

Recurring

WP2 to present at IRISS meeting

Virtual

Monthly IRISS meeting IRISS is a non-profit dedicated to advancing Implementation of Regulatory Information and Submission Standards for life sciences globally, see https://iriss-forum.org/.

UNICOM Community of Expertise: Vaccine challenges – cleansing, confidentiality, and vaccine naming

The need for global identification of vaccines has been recognized in the Global Vaccines Initiative, addressing the global surveillance of vaccine effectiveness and risks. This has particular consequences for the European Substance Registration System, the focus of UNICOM WP 2, which will need to make sure that cleansing and building of substances is done in […]

Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms

The Digital Application Dataset Integration (DADI) project will replace PDF electronic application forms (eAF) used for regulatory submissions with online forms, making the future form-filling and submission-handling process more efficient. This first public webinar is for stakeholders from the human & veterinary medicines industry and national competent authorities wishing to learn more about the following: DADI roadmap […]

Digital application dataset integration (DADI) webinar – common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Article 57(2) and electronic application forms (eAF)

This second public webinar is for technical experts from industry and national competent authorities wishing to learn more about the design of the FHIR message for the first form to be updated: Human Variations. Despite the focus on human medicines, all stakeholders interested in the technical aspects of the FHIR message are welcome. Topics addressed in this webinar […]