CIOMS Geneva Meeting

In 2018 IFAPP, the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine, joined CIOMS, the Council for International Organizations of Medical Sciences, a non-governmental organization founded in 1949 by the WHO and UNESCO.  On the occasion of CIOMS’ 70th anniversary invited to an Open Meeting in Geneva that Brigitte Franke-Bray, IFAPP Treasurer and…

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Association des Métiers Médicaux des Industriels de Santé

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…

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IN MEMORIAM TO Dr. Herman Lahon (1928-2018)

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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EMA: Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU

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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EMA: Modernising the orphan designation process

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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EMA: Reinforced EU/US collaboration on medicines

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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"The Time is Now to Professionalize the Clinical Trial Industry"

    “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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FDA Basics for Industry

  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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Ten years promoting high-quality scientific research in paediatric medicines

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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Updated rules for clinical development of vaccines

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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