Scientific article
Found 3 free book(s)Guide to Scientific Writing - MIT OpenCourseWare
ocw.mit.eduGuidelines for Introductions from Two Scientific Organizations From the International Committee of Medical Journal Editors: State the purpose of the article and summarize the rationale for the study or observation. Give only strictly pertinent references and do not include data or conclusions from the work being reported.
European Medicines Agency Guidance for Applicants …
www.ema.europa.eu1. What is the legal basis of scientific advice? According to Article 57-1 (n) of Regulation (EC) No 726/2004 of the European Parli ament and of the Council of 31 March 2004, one of the tasks of the Agency is "advising undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euArticle 8(3)(ia) of Directive 2001/83/EC requires a summary of the applicant’s pharmacovigilance system to be included in the marketing authorisation application, which shall include the following elements in module 1.8.1 of the dossier: