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At least 145 records · Page 8Linked to original sources
PubMed1994

Licensing and control authority batch release of influenza vaccine in Germany in accordance with EEC regulations.

The epidemiological situation calls for almost yearly changes in the antigenic composition of influenza vaccine, thus necessitating fresh licensing procedures. Since the time for bringing a new vaccine onto the market should be relatively short, the following work of all parties involved must be done expeditiously: 1) WHO recommendations on new virus strains and their subsequent adaptation by the EEC (February/March); 2) Distribution of the new virus strains to the International Reference Centers for Influenza in the UK and USA (February/March); the centers later issue reference materials for the determination of the haemagglutinin antigen concentration (April/May); 3) Production and testing of seed virus by manufacturers, as well as validation of the producer's inactivation process for the new virus strains (May/June); 4) Licensing of the vaccines by the National Control Authority (Paul-Ehrlich-Institute) (June/July); in the case of previously licensed products, the procedure is limited essentially to the approval of the detailed protocol of production and tests on the new virus strains, clinical studies not being required before licensing because of a lack of time; 5) Paul-Ehrlich-Institute's test for batch release, according to Directive 89/342/EEC, besides protocol approval, conducts material testing of the endotoxin and antigen content of each vaccine lot; the assay for the antigen quantification is especially laborious and sometimes must be repeated because of test invalidity.

Antigens, Viral↗
PubMed1999

[Expert-assessment of suitability for a driving license in otorhinolaryngology].

An absolute requirement for acquiring a driving license according to German law consists in the suitability for driving a motor vehicle. The "driving license decree" defines these requirements; in case of doubt the administrative authority may demand a medical certificate. According to law (enactment: 1.1.99) these medical certificates must be refunded by either appropriate medical specialists, company doctors or public health officers. The criterions for appraisal are set down in the guidelines for driving ability which are edited by the advisory board for traffic medicine; a new edition will be published soon. Concerning otorhinolaryngology hearing impairment and dizziness are the most relevant diseases. Bilateral deafness is no general exception for conferring a driving license for the classes A and B; for classes C and DE hearing loss, established from the pure tone audiogram must not exceed 60%; an exceptional case is a three year demonstration of reliability in class B. Permanent dizziness or vertigo attacks are in most cases incompatible with conferring driving licenses. The most important issue for medical appraisal is to determine the amount of compensation of the impaired sense organ. Therefore in cases of multiple disabilities more stringent criterions must be established.

Automobile Driving↗
PubMed1985

Teenage driver licensing in relation to state laws.

Previous studies have shown that delaying licensure reduces motor vehicle injuries. This study examined the relationship between licensing laws and the timing of obtaining drivers licenses. The states studied have various laws, including minimum licensing ages of 15, 16 and 17; minimum learners permit ages of 15 and 16; and teenage night driving curfews. A questionnaire survey of 52,304 students was conducted in 75 high schools during the spring of 1983. The schools were selected from Orange County, California; rural Colorado; and most or all of Louisiana, Michigan, Mississippi, New Jersey and New York. The results indicated that the minimum age of licensure has obvious strong effects in delaying licensure. Setting the learners permit age later also apparently delays licensure. The night driving curfew in New York State (9 p.m.-5 a.m.) is seen by students as a factor in their decisions to delay obtaining licenses; Louisiana's 11 p.m.-5 a.m. curfew has a much smaller effect, if any.

Accidents, Traffic↗
PubMed1995

The relationship of age and state license renewal policies to driving licensure rates.

We employ regression analysis to examine the relationship of state driver's license renewal requirements, population characteristics, and driving conditions to state driving licensure rates. Licensure rates are examined for the years 1985 through 1989. We separately examine all-age and senior licensed drivers. We find that license renewal requirements as well as population characteristics and driving conditions have systematic relationships to licensure rates. In particular, license renewal tests are associated with lower senior driving licensure rates.

Adolescent↗
PubMed1984

Obstacles to the practice of licensed lay midwifery.

Intensive interviews with licensed lay midwives in one of ten states that have recently reactivated and revised legislation legalizing such alternative practitioners for low risk clientele revealed a number of obstacles to their practice. The obstacles stem from the same rules and regulations developed by medical practitioners that made their homebirth service legal. Even after surmounting the difficulties of obtaining a license, the midwives find widespread unwillingness among private physicians to provide the required prenatal screening examination and medical back-up. The opposition of physicians to the licensed midwifery program is voiced in terms of concern about the safety of homebirths, particularly those attended by nonphysicians. Yet, the outcomes from the first 4 years of the program give no support for such concerns. Physician reluctance to cooperate with the legal program, combined with restrictions prohibiting the licensed midwives from suturing minor tears and administering a single dose of an antihemorrhagic drug in an emergency transfer, do compromise the overall quality of midwifery care. While accepting their subordinate position to medical practitioners, the midwives are struggling to establish the continuum of care for homebirth women implied in their licensure law.

Adult↗
PubMed2004

Some consequences of different older driver licensing procedures in Australia.

Given both the expected growth in the number of older drivers and their over-involvement in fatal and serious injury crashes, there has been a world-wide call for improved licensing procedures to manage older driver safety. In particular, licensing authorities have been urged to move from mandatory assessment of all older drivers to assessment practices targeting only those at higher crash risk. The current study examined older driver fatal and serious injury crash involvement rates across all Australian States to determine a possible association with the different licensing procedures. In particular, older driver crash involvement rates in Victoria (where there is no age-based assessment program) have been compared with rates in other jurisdictions with assessment programs. Crash involvement rates have been calculated using two denominators: per population and per number of licensed drivers. Some data limitations notwithstanding, older drivers in jurisdictions with age-based mandatory assessment programs could not be shown to be safer than drivers in Victoria. Further, there is some indicative evidence that older drivers in Victoria may have a significantly safer record regarding overall involvement in serious casualty crashes.

Accidents, Traffic↗
PubMed2005

CDKs promote DNA replication origin licensing in human cells by protecting Cdc6 from APC/C-dependent proteolysis.

Cyclin-dependent kinases (CDKs) restrict DNA replication origin firing to once per cell cycle by preventing the assembly of prereplicative complexes (pre-RCs; licensing) outside of G1 phase. Paradoxically, under certain circumstances, CDKs such as cyclin E-cdk2 are also required to promote licensing. Here, we show that CDK phosphorylation of the essential licensing factor Cdc6 stabilizes it by preventing its association with the anaphase promoting complex/cyclosome (APC/C). APC/C-dependent Cdc6 proteolysis prevents pre-RC assembly in quiescent cells and, when cells reenter the cell cycle from quiescence, CDK-dependent Cdc6 stabilization allows Cdc6 to accumulate before the licensing inhibitors geminin and cyclin A which are also APC/C substrates. This novel mechanism for regulating protein stability establishes a window of time prior to S phase when pre-RCs can assemble which we propose represents a critical function of cyclin E.

Anaphase-Promoting Complex-Cyclosome↗
PubMedDate not supplied

Licensing web-based nursing programs, courses, and course materials.

With the advent of the digital information age, schools of nursing are developing and using web-based programs, courses, and course materials to meet students' needs for access and high-quality learning experiences. In an attempt to maximize scant resources, including faculty, many schools are seeking grant funding, joining consortia, or forming partnerships that require sharing of web-based course materials. Entering such collaborative arrangements usually requires licensing agreements to transfer intellectual capital. This article explains licensing and the related concepts of intellectual property, copyright, and technology transfer. It also identifies the advantages and disadvantages of licensing and describes a licensing process.

Computer-Assisted Instruction↗
PubMed2006

Gene patents, health care policy and licensing schemes.

Human gene patents continue to stir social controversy, including the possibility that they might adversely affect public access to useful technologies. It has been suggested that a compulsory licensing policy might be used to alleviate the adverse effect of patents in this context. We suggest, however, that it is unclear whether existing international policies and licensing practices will permit compulsory licensing to be used in a way that would address common concerns. Indeed, given the minor role that genetic technologies have in most health care systems, it would be difficult to justify compulsory licensing. At a minimum, policy makers need to be more realistic about the potential effects of international trade agreements on the development of biotechnology policies.

Genetic Research↗
PubMed1997

Effects of administrative license revocation on employment.

This study addresses the impact of administrative license revocation (ALR) on the employment and income of first and multiple drunk-driving (DUI) offenders. It also inquires into the impact of alcohol-related crashes on the employment of other persons involved in such crashes (i.e. innocent drivers, passengers and pedestrians). Questionnaires were completed by 579 first-time offenders and 233 multiple offenders at alcohol education schools and treatment programs in four counties in four states, which represented varying ALR laws: Chester County, PA (without ALR); Anne Arundel County, MD (ALR with immediate hardship license available); Marin County, CA (30-day hard license suspension); and New Castle County, DE (90-day hard license suspension). Completed crash 'victim' surveys were returned by 146 crash victims from Pennsylvania, California and Delaware. The study found that ALR does not have a major impact on the DUI offender's job and income. Alcohol-involved crashes can have a great impact on seriously injured victims, but the proportion of DUI crashes producing serious injury is quite low. Most DUI is crash-free, and most crashes do not involve injury. The vast bulk of the impact of DUI events falls on the offenders rather than innocent victims.

Alcohol Drinking↗
PubMed2003

New Zealand drivers study: developing a methodology for conducting a follow-up study of newly licensed drivers.

PROBLEM: In recent years, there has been a significant reduction in traffic crash injury among young people, but they continue to be overrepresented in the traffic crash statistics. To improve this situation, sound scientific evidence is needed to develop effective policies and programs. METHOD: The aim of the proposed study is to provide this evidence by examining early driving and driving-related experiences of newly licensed drivers as they progress through the learner-, restricted-, and full-license stages of the graduated licensing system and to determine the impact of these experiences on subsequent negative traffic-related outcomes (risky driving behavior, injury traffic crashes, noninjury traffic crashes, infringements, convictions). Given the size and complexity of the proposed study, a comprehensive pilot study was undertaken to determine the feasibility of conducting a New Zealand-wide cohort study of newly licensed drivers. RESULTS: This article describes the pilot study process and the methodology that has been developed for the New Zealand-wide study.

Accidents, Traffic↗
PubMed2003

Chiropractic-primary care, neuromusculoskeletal care, or musculoskeletal care? Results of a survey of chiropractic college presidents, chiropractic organization leaders, and Connecticut-licensed doctors of chiropractic.

BACKGROUND: The Connecticut Chiropractic Association authorized an ad hoc committee to study Connecticut chiropractic scope of practice in January 1999. This committee was chaired by Richard Duenas, DC, and included 4 other Connecticut-licensed doctors of chiropractic who responded to an appeal to participate. OBJECTIVE: Committee members investigated the terms primary care, primary care provider (PCP) (clinician, physician), neuromusculoskeletal care, neuromusculoskeletal care provider (clinician, physician), musculoskeletal care, and musculoskeletal care provider (clinician, physician) to determine which, if any, apply to the practice of chiropractic. DATA SOURCES: A literature review was performed with in-depth analysis of the definitions of these terms and an interpretation of Connecticut Statutes for chiropractic, comparing the legal description of chiropractic practice to the term definitions. The literature review produced several detailed definitions of primary care and/or primary care provider (clinician, physician); however, no accurate description of neuromusculoskeletal (NMS) care or musculoskeletal care was found. RESULTS: Two opinion surveys were conducted: 1 survey included presidents of accredited chiropractic colleges, as well as leaders of chiropractic organizations throughout the world. The other survey was sent to doctors of chiropractic (DC) licensed in the State of Connecticut. Survey topics addressed definitions of primary care and PCP, the formulation of these terms, neuromusculoskeletal care and neuromusculoskeletal care provider, individual rights in selecting a PCP, and the types of practitioners considered PCPs. The consensus among chiropractic college presidents, organization leaders, and Connecticut-licensed doctors of chiropractic was that the doctor of chiropractic is qualified to provide primary care. Most considered any definition of primary care invalid if the chiropractic profession was not involved in its formulation. The overwhelming majority felt the patient should retain the ultimate choice in determining who should be their PCP. Mission statements of accredited chiropractic colleges were reviewed, paying particular attention to educational goals and professional qualifications of graduates. The committee found these institutions strive to train students in all aspects of primary care. CONCLUSIONS: Upon review of the literature and term definitions, interpretation of the statutes pertaining to chiropractic practice, results of both surveys, and review of the chiropractic college mission statements, the committee concluded that the Connecticut-licensed DC, by education, licensure, definition, and intraprofessional consensus, qualifies as a PCP.

Attitude of Health Personnel↗
PubMed2002

Replication licensing--defining the proliferative state?

The proliferation of eukaryotic cells is a highly regulated process that depends on the precise duplication of chromosomal DNA in each cell cycle. Regulation of the replication licensing system, which promotes the assembly of complexes of proteins termed Mcm2-7 onto replication origins, is responsible for preventing re-replication of DNA in a single cell cycle. Recent work has shown how the licensing system is directly controlled by cyclin-dependent kinases (CDKs). Repression of origin licensing is emerging as a ubiquitous route by which the proliferative capacity of cells is lowered, and Mcm2-Mcm7 proteins show promise as diagnostic markers of early cancer stages. These results have prompted us to propose a functional distinction between the proliferative state and the non-proliferative state (including G0) depending on whether origins are licensed.

Animals↗
PubMed2003

Effects of patents and licenses on the provision of clinical genetic testing services.

The growth of patents that include genetic sequences has been accompanied by concern about their impact on the ability of physicians to provide clinical genetic testing services and to perform research. Therefore, we conducted a survey of clinical laboratory directors that perform DNA-based genetic tests to examine potential effects. We performed a telephone survey between July and September in 2001 of all laboratory directors in the United States who were members of the Association for Molecular Pathology or who were listed on the GENETESTS:org website. One hundred thirty-two of 211 (63%) laboratory directors were interviewed. Ten of these were excluded because they did not conduct DNA-based genetic tests. Almost all performed genetic tests for clinical purposes. Half performed tests for research purposes as well. Twenty-five percent of respondents reported that they had stopped performing a clinical genetic test because of a patent or license. Fifty-three percent of respondents reported deciding not to develop a new clinical genetic test because of a patent or license. In total, respondents were prevented from performing 12 genetic tests, and all of these tests were among those performed by a large number of laboratories. We found 22 patents that were relevant to the performance of these 12 tests. Fifteen of the 22 patents (68%) are held by universities or research institutes, and 13 of the 22 patents (59%) were based on research funded by the United States Government. Overall, respondents reported that their perceptions of the effects of patents on the cost, access, and development of genetic tests, or data sharing among researchers, were negative. In contrast, most respondents felt that patents did not have an effect on the quality of testing. We conclude that patents and licenses have had a significant effect on the ability of clinical laboratories to develop and provide genetic tests. Furthermore, our findings suggest that clinical geneticists feel that their research is inhibited by patents. The effects of patents and licenses on patients' access to tests, and the costs and quality thereof, remains to be determined.

Data Collection↗
PubMed2002

Predictive validity of the Medical College Admissions Test Writing Sample for the United States medical licensing examination steps 1 and 2.

Despite the amount of published research on the predictive validity of the Medical College Admissions Test (MCAT) taken as a whole, few published reports separate the individual predictive validity of the Writing Sample. The purpose of this study is to provide data on the predictive validity of the Writing Sample for the national licensing exam used in the United States. Subjects consisted of 1992-1995 matriculants from a publicly owned medical school in the Southeastern United States. Independent variables were undergraduate grade point average, and four section scores on a required admissions test (Biological Sciences, Physical Sciences, Verbal Reasoning, and Writing Sample). The dependent variables were Steps 1 and 2 on the three step licensing examination. Steps 1 and 2 of the examination are taken during medical school. Multiple regression models calculated additional variance accounted for by the addition of the Writing Sample to a model containing grade point average and the other admissions test section scores. In multivariate analyses, when grade point average and all admissions test scores were considered as predictors of licensing exam scores, the Writing Sample variable did not add to the ability to predicting the Step 1 or Step 2 scores. The results of this study suggest that the Writing Sample has limited predictive validity for assessing success on a national licensing exam. However, as others suggest, the value of the Writing Sample and other surrogates of communication probably lie in predicting performance in the clinical years of medical school and beyond. Additional work should include evaluating the predictive validity of the Writing Sample and other pre-medical school measures of communication with widely acceptable measures of performance in clinical settings, including physician-patient communication.

Adult↗
PubMed2003

CUL-4 ubiquitin ligase maintains genome stability by restraining DNA-replication licensing.

To maintain genome stability, DNA replication is strictly regulated to occur only once per cell cycle. In eukaryotes, the presence of 'licensing proteins' at replication origins during the G1 cell-cycle phase allows the formation of the pre-replicative complex. The removal of licensing proteins from chromatin during the S phase ensures that origins fire only once per cell cycle. Here we show that the CUL-4 ubiquitin ligase temporally restricts DNA-replication licensing in Caenorhabditis elegans. Inactivation of CUL-4 causes massive DNA re-replication, producing cells with up to 100C DNA content. The C. elegans orthologue of the replication-licensing factor Cdt1 (refs 2, 3) is required for DNA replication. C. elegans CDT-1 is present in G1-phase nuclei but disappears as cells enter S phase. In cells lacking CUL-4, CDT-1 levels fail to decrease during S phase and instead remain constant in the re-replicating cells. Removal of one genomic copy of cdt-1 suppresses the cul-4 re-replication phenotype. We propose that CUL-4 prevents aberrant re-initiation of DNA replication, at least in part, by facilitating the degradation of CDT-1.

Animals↗
PubMed2006

A Cdt1-geminin complex licenses chromatin for DNA replication and prevents rereplication during S phase in Xenopus.

Initiation of DNA synthesis involves the loading of the MCM2-7 helicase onto chromatin by Cdt1 (origin licensing). Geminin is thought to prevent relicensing by binding and inhibiting Cdt1. Here we show, using Xenopus egg extracts, that geminin binding to Cdt1 is not sufficient to block its activity and that a Cdt1-geminin complex licenses chromatin, but prevents rereplication, working as a molecular switch at replication origins. We demonstrate that geminin is recruited to chromatin already during licensing, while bulk geminin is recruited at the onset of S phase. A recombinant Cdt1-geminin complex binds chromatin, interacts with the MCM2-7 complex and licenses chromatin once per cell cycle. Accordingly, while recombinant Cdt1 induces rereplication in G1 or G2 and activates an ATM/ATR-dependent checkpoint, the Cdt1-geminin complex does not. We further demonstrate that the stoichiometry of the Cdt1-geminin complex regulates its activity. Our results suggest a model in which the MCM2-7 helicase is loaded onto chromatin by a Cdt1-geminin complex, which is inactivated upon origin firing by binding additional geminin. This origin inactivation reaction does not occur if only free Cdt1 is present on chromatin.

Animals↗
PubMed2001

Influence of curriculum type on student performance in the United States Medical Licensing Examination Step 1 and Step 2 exams: problem-based learning vs. lecture-based curriculum.

INTRODUCTION: The results of the United States Medical Licensing Examination Step 1 and 2 examinations are reported for students enrolled in a problem-based and traditional lecture-based curricula over a seven-year period at a single institution. There were no statistically significant differences in mean scores on either examination over the seven year period as a whole. There were statistically significant main effects noted by cohort year and curricular track for both the Step 1 and 2 examinations. These results support the general, long-term effectiveness of problem-based learning with respect to basic and clinical science knowledge acquisition. CONTEXT: This paper reports the United States Medical Licensing Examination Step 1 and Step 2 results for students enrolled in a problem-based and traditional lecture-based learning curricula over the seven-year period (1992-98) in order to evaluate the adequacy of each curriculum in supporting students learning of the basic and clinical sciences. METHODS: Six hundred and eighty-nine students who took the United States Medical Licensing Examination Step 1 and 540 students who took Step 2 for the first time over the seven-year period were included in the analyses. T-test analyses were utilized to compare students' Step 1 and Step 2 performance by curriculum groups. RESULTS: United States Medical Licensing Examination Step 1 scores over the seven-year period were 214 for Traditional Curriculum students and 208 for Parallel Curriculum students (t-value = 1.32, P=0.21). Mean Step 2 scores over the seven-year period were 208 for Traditional Curriculum students and 206 for Parallel Curriculum students (t-value=1.08, P=0.30). Statistically significant main effects were noted by cohort year and curricular track for both the Step 1 and Step 2 examinations. CONCLUSION: The totality of experience in both groups, although differing by curricular type, may be similar enough that the comparable scores are what should be expected. These results should be reassuring to curricular planners and faculty that problem-based learning can provide students with the knowledge needed for the subsequent phases of their medical education.

Curriculum↗