Search results for "Licensure"
showing 8 items of 8 documents
International Bordetella pertussis assay standardization and harmonization meeting report. Centers for Disease Control and Prevention, Atlanta, Georg…
2009
An international meeting on Bordetella pertussis assay standardization and harmonization was held at the Centers for Disease Control and Prevention (CDC), Atlanta, GA, 19-20 July 2007. The goal of the meeting was to harmonize the immunoassays used for pertussis diagnostics and vaccine evaluation, as agreed upon by academic and government researchers, regulatory authorities, vaccine manufacturers, and the World Health Organization (WHO). The primary objectives were (1) to provide epidemiologic, laboratory, and statistical background for support of global harmonization; (2) to overview the current status of global epidemiology, pathogenesis and immunology of pertussis; (3) to develop a consen…
Effectiveness of hexavalent vaccines against invasive Haemophilus influenzae type b disease: Germany's experience after 5 years of licensure
2007
Summary Vaccine effectiveness (VE) was determined with a case-cohort approach using Cox regression. Cases with confirmed systemic Hib infections in children born from 1 August 2000 to 31 December 2004 were ascertained through two independent nationwide active surveillance systems. A representative cohort of 1303 children born in the same time frame was randomly sampled in a nationwide immunisation survey. Thirty cases were eligible for VE calculation; 19 were unvaccinated and 11 vaccinated with hexavalent vaccines. VE was 68.4% (95% CI: 19.0–87.6) for incomplete primary series and 90.4% (95% CI: 70.6–96.8) for the full primary series. For full immunisation VE was 100.0% (95% CI: 52.7–100.0)…
Development and validation of the Spanish Hazard Perception Test.
2014
The aim of the current study is to develop and obtain valid evidence for a hazard perception test suitable for the Spanish driving population. To obtain valid evidence to support the use of the test, the effect of hazardous and quasi-hazardous situations on the participants' hazard prediction is analyzed and the pattern of results for drivers with different driving experience--that is, learner, novice, and expert drivers and reoffender vs. nonoffender drivers--is compared. Potentially hazardous situations are those that develop without involving any real hazard (i.e., the driver did not actually have to decelerate or make any evasive maneuver to avoid a potential collision). The current stu…
Clinical practice evaluation of opioids induced constipation management in cancer patients: The EIO-Praxis project
2019
Abstract Background In 2017, the ECO Foundation (Excellence and Quality in Oncology) completed the EIO-50 project to learn about the diagnostic and treatment criteria of opioid-induced constipation (OIC) in cancer patients. The EIO-Praxis project was designed as a continuation of EIO-50, to learn about the current clinical practice of oncology professionals for the management of patients with OIC (process, follow-up and results). Methods 77 health care professionals (HCP) from oncology units participated in the study. Each investigator collected information from 10 medical records of cancer patients who received OIC treatment, with a total of 770 records. In each center, 6 indicators of its…
Chapter 14: HPV vaccine introduction in industrialized countries.
2006
Introduction of a vaccine requires the achievement of three initial milestones. These are licensure by a national control authority that determines the vaccine is safe and effective, development of recommendations for use by expert advisory bodies on immunization, and obtaining funding for vaccination. Once these milestones have been achieved, a successful vaccination program requires that a number of interlinked programmatic components be brought together in a coordinated fashion. These include vaccine purchase and supply, vaccination service delivery, high coverage rates, surveillance of the vaccination program, immunization finance policies and practices, and political will. Human papill…
Chapter 22: Assuring the quality, safety and efficacy of HPV vaccines: The scientific basis of regulatory expectations pre- and post-licensure
2006
The potential of human papillomavirus (HPV) vaccines will only be realized if the vaccine candidates under development prove to be safe and effective and can be consistently produced to define quality standards. Whilst the responsibility for delivering a safe and effective product rests with the vaccine producer, a vaccine requires a license to allow it to be placed on the market. Licensure is based on an evaluation of the safety and efficacy profile of a vaccine candidate by national regulatory authorities, ideally on the basis of internationally agreed, science-based specifications and procedures. For vaccines, these international specifications are developed by the World Health Organizat…
New rules on driver licensing for patients with obstructive sleep apnoea: EU Directive 2014/85/EU.
2016
The widespread recognition that obstructive sleep apnoea (OSA) represents an important risk factor for motor vehicle accidents (MVA), which is reversed by successful therapy with continuous positive airway pressure (CPAP), has led to a revision of annex III of the European Union (EU) directive on driving licences that is subject to mandatory implementation by all member states from December 31, 2015 [1]. This directive was the result of recommendations from a working group established by the Transport and Mobility Directorate of the European Commission in 2012 [2]. The directive states [1] Joint ERS/ESRS working group on the EU directive on issuing driving licences in obstructive sleep apno…
Investigator-initiated trials of targeted oncology agents: why independent research is at risk?
2010
Background: Drug development traditionally has relied upon the complementary contributions of clinicians and scientists at academic institutions and at pharmaceutical companies. Greater regulatory burdens, increased bureaucratic requirements, restricted reimbursement, and spiralling research and development costs are exerting pressure on the drug development pipeline. The result is a de-emphasis of exploratory research, particularly independent academic research, despite its proven value in identifying new drug targets and developing innovative cancer therapies. Design: An expert panel assembled by the Biotherapy Development Association-a nonprofit international forum for academic and indus…