Posts by Anna Jurczynska

The first Real World Evidence Conference was held in France on 11th June 2019. It was organized by AMMIS, IFAPP’s French National Member Association. Modern health systems produce huge amounts of health data, and more data are generated outside these systems through multiple human activities (social networks, connected objects, applications and so on). Health authorities…

In delivering on its objective to internationalize the advancement of knowledge in medicines development and Pharmaceutical Medicine (PM) by sharing best practices of its National Member Associations (NMAs), IFAPP historically published a paper-driven newsletter called “IFAPP News” for communication to the worldwide PM community. This time-consuming and costly process of the pre-digital era was followed…

History of the AMMIS AMMIS (previously called AMIPS) is medical and scientific organization re-founded in 2018. It is a not-for-profit association and exists solely for the benefit of its members. Currently AMMIS has approximately 100 members. Who are AMMIS members? AMMIS is open to anyone who, through their expertise, contribute to the development of innovative…

Dr. Herman Lahon (1928-2018), Honorary Life President of IFAPPDr. Herman Lahon, Honorary Life President of IFAPP passed away on 16 July 2018 at the age of 89 years Herman was the quintessential Pharmaceutical Physician. Born and raised in Belgium, he was truly a man of the world. Herman was the founding President of IFAPP in…

19/06/2018 Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU Publication of updated Q+As and practical guidance The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Updates to the questions-and-answers document are marked…

19/06/2018 Modernising the orphan designation process EMA launches new submission portal today The European Medicines Agency (EMA) has launched a new secure online portal for orphan designation applications. The portal, named ‘Iris’, provides a single space where applicants can submit and manage the information and documents related to their applications for orphan designation. This is…

The EC/EMA and FDA will continue their strong cooperation in numerous activities under their responsibilities, including innovation. The activities planned in the next couple of years will need to take into account EMA’s business continuity needs during and after its relocation to Amsterdam. This document was originally posted by the EMA here. 

    “It’s a sin not to [advance] professionalization in the clinical trial industry,” Robert O’Neill, the U.S. Food and Drug Administration’s (FDA’s) senior statistical advisor for the Office of Translational Sciences in the Center for Drug Evaluation and Research, told attendees of the DIA 2018 Global Annual Meeting in Boston this week. “It’s really…

  How do i know if my product is regulated by the FDA? It depends on what the product is and how it is marketed. For more information, see FDA’s general navigation guide for manufacturers of FDA-regulated products and start-ups. what should I expect during an inspection? FDA may conduct an inspection of your operation…