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…

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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…

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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…

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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. 

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    “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…

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  What was your motivation to join IFAPP? I learned of IFAPP when I joined Japanese member association more than two decades ago, but little information was available in those days. I rarely received news from House of Delegate meeting / General Assembly and ICPM. Since we started our regular educational seminars in Japan in…

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  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…

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The second day of the workshop is reserved for discussions among the members of Enpr-EMA and its coordinating group. The coordinating group will define priority tasks for 2018–19 based on the feedback received from stakeholders. Individuals interested in attending the first day of the workshop are invited to send a completed registration form to enprema@ema.europa.eu before 28 May 2018.…

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26/04/2018 EMA launches public consultation on revised guideline on clinical evaluation of vaccines The European Medicines Agency (EMA) has released a revised guideline on the clinical evaluation of vaccines for a six-month public consultation. Stakeholders are invited to send their comments by 30 October 2018 to vwp@ema.europa.eu using the template provided in the guideline. Vaccination is one of the greatest breakthroughs in modern medicine.…

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Civil society representatives wanted for EMA’s Management Board and Pharmacovigilance Committee 30/04/2018 Submission deadline is 8 June 2018 The European Commission has launched a call for expressions of interest for civil society representatives to join the Management Board of the European Medicines Agency (EMA), as well as the Agency’s Pharmacovigilance Risk Assessment Committee(PRAC). This is an opportunity for civil society representatives to…

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