نتایج جستجو برای: regulatory authorities
تعداد نتایج: 209746 فیلتر نتایج به سال:
Pioglitazone suspension and its aftermath: A wake up call for the Indian drug regulatory authorities
in this paper, it’s been tried to examine the legalframework of self-regulatory organizations in iran and the us’scapital markets and to clarify this matter in iran and the us (as theinnovator of self-regulation method in some way for setting rules andregulations), with emphasis on laws and practices. to achieve thispurpose, we analyzed this matter from the most important angles;therefore, in t...
Abstract The present study seeks to contribute a better understanding of policy diffusion processes, more specifically, the process from transnational arena that influenced regulation Good Manufacturing Practices (GMP) for medicinal products in Brazil context surrounded by international authorities. By conducting qualitative research, we analyzed adhesion Brazilian Health Regulatory Agency (Anv...
The approach of the European Medicines Agency (EMEA) to good laboratory practice (GLP) inspections in the context of authorization of medicinal products is illustrated with particular reference to the EMEA's experience as a receiving authority (RA), the procedures it has in place for the reporting and follow-up of GLP inspections, and the role of the ad hoc GLP inspectors working group. Other k...
BACKGROUND The substitution principle has been included in the EU pesticides legislation as a new element. Comparative assessments will have to be conducted for all uses of plant protection products (PPPs) that contain active substances with certain hazardous properties, the so-called candidates for substitution (CFS). This study investigated the resulting workload in terms of the number of cas...
This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts.
This chapter covers the fundamental roles played by public authorities in prevention of chemical accidents. In this chapter, term “public authorities” includes wide range government bodies at local, regional and national levels that are responsible for environmental protection, health, occupational health safety, civil defence, emergency response other aspects accident prevention, preparedness ...
Copyright © Polskie Towarzystwo Kardiologiczne symptoms to be accurately diagnosed, undergoing 4–5 consultations yearly. Additionally, around 25% of these patients need to travel to a different region to reach a diagnostic facility. The unmet needs of the growing number of patients with RDs in general call for special and combined efforts of regulatory authorities, health care providers, scient...
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