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EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. [8] EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10]
The WHO Smart Guidelines are part of a broader global trend of digitizing clinical guidelines to make them more actionable in healthcare systems. For example, the Centers for Disease Control and Prevention (CDC) in the United States developed the "Adapting Clinical Guidelines for the Digital Age" (ACG) initiative, which promotes a holistic ...
The European Medicines Agency (EMA) is responsible for the development, assessment and supervision of medicines in the EU. The appointed committees are involved in referral procedures concerning safety or the balance of benefit/risk of a medicinal product. In addition, the committees organize inspections with regards to the conditions under ...
Readability is the ease with which a reader can understand a written text. In natural language , the readability of text depends on its content (the complexity of its vocabulary and syntax ) and its presentation (such as typographic aspects that affect legibility , like font size , line height , character spacing , and line length ).
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
Volume 7 - Guidelines. Volume 8 - Maximum residue limits. Concerning Medicinal Products for Human and Veterinary use: Volume 4 - Good Manufacturing Practices. Volume 9 - Pharmacovigilance. Miscellaneous: Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products.
For example, a German version is jointly published by Austria, Germany and Switzerland. In the future, the former three-year cycle comprising one edition and eight supplements will be replaced by an annual edition made up of three issues, numbered .1 to .3 (for example, the 12th Edition will consist of issues 12.1, 12.2 and 12.3).