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Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized…
In Europe, sponsors must possess a compliant Paediatric Investigation Plan (PIP) when applying for marketing approval of drugs. The core deliverable is the ‘scientific part of the application’ structured according to the EMA's PIP guideline. The PIP…
A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.
The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…
A successful medical writer needs to be an excellent time manager, communicator, and team player, and show great attention to detail and commercial awareness, in addition to possessing core writing skills and the ability to evaluate and…
This paper provides an overview of contemporary medical illustration; the role of the modern medical illustrator is examined, including who they are likely to work for and with, as well as the range of media and technology employed. The…
Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…
This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…
Abstract Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single…
Observational studies pose a number of biostatistical challenges. Methodological approaches have grown exponentially, but most are rarely applied in the real world. The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative…
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