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Michael Makris on Twitter: "The European Medicines Agency @EMA_News has approved the Pfizer #COVID19 vaccine for use in children aged 12-15. It will be interesting to see if countries go for complete
Choice of timetable for type II variations and worksharing applications
The impact of FDA and EMA regulatory decision-making process on the access to CFTR modulators for the treatment of cystic fibrosis | Orphanet Journal of Rare Diseases | Full Text
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ARTICLE OF THE YEAR: The linguistic review process in the centralized procedure in the EU | RAPS
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Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches - Rei Bolislis - 2021 - Clinical Pharmacology & Therapeutics - Wiley Online Library
Choice of timetable for type II variations and worksharing applications
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Strategies & Applications Behind The 50-Day EMA (INTC, AAPL)
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EMA Publishes New Timeline For DADI Project | EXTEDO
Use of Real-world Data for New Drug Applications and Line Extensions - Clinical Therapeutics
Frontiers | Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?
Type-IB variations: questions and answers | European Medicines Agency
NAVIGATING THE EMA
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NAVIGATING THE EMA
Type-II variations: questions and answers | European Medicines Agency
Use of Real-world Data for New Drug Applications and Line Extensions - Clinical Therapeutics
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The Alstom/Cosider consortium and EMA celebrate the entry into commercial service of part 1 of the Constantine tramway line extension | Alstom
Frontiers | Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe
Webinar for Industry – Mandatory use of eSub Gateway for veterinary submissions to EMA - YouTube
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