294 results match your criteria: "Institute of Law[Affiliation]"

Despite the fact that the rules for obtaining reference material for handwriting expert opinion are specified in the literature and remain unchanged for years, the judicial authorities often do not use them. The experts themselves also do not attach due importance to the quality and quantity of reference material and remain contented with material diverging from the recommended one. The described case demonstrates that such an approach can lead to mistakes and the rules for collecting reference material should be observed not only in complicated cases but also in seemingly uncomplicated ones.

View Article and Find Full Text PDF

Accessibility of cancer drugs in Switzerland: Time from approval to pricing decision between 2009 and 2018.

Health Policy

March 2020

Institute of Diagnostic and Interventional Radiology, University Hospital of Zurich / University of Zurich, Department of Nuclear Medicine, University Hospital of Zurich/University of Zurich, Zurich, Switzerland.

Background: Approved drugs must be included on the so-called "special list" (SL) by the Federal Office for Public Health (FOPH) to be reimbursed by the social health insurance in Switzerland. The FOPH decides whether a drug may be included on SL and if so, negotiates the maximum price with the manufacturer. Time period between approval and inclusion on SL is important to evaluate accessibility of patients to drugs.

View Article and Find Full Text PDF

Rapeseed is an essential crop which is used in many different areas as edible oil, biodiesel, lubricant, and feed. It is one of the most popular oil crops in Europe (63% of oilseeds production in 2017). The current study highlights the potential for further rapeseed development in European Union (EU), with special emphasis on Germany (19% of EU production) and Poland (12% of EU production).

View Article and Find Full Text PDF

Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.

BMJ Open

October 2019

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

Objective: To determine differences in the characteristics of cancer drugs designated as orphan drugs by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Design And Setting: Identification of all cancer drugs (initial or supplementary indication) with orphan status approved by the FDA between 2008-2017 based on publicly accessible reports. The European public assessment reports (EPAR) was searched to determine whether these FDA-approved drugs were also approved by the EMA.

View Article and Find Full Text PDF

The aim of the study is to identify topical issues of the regulatory framework and the application of legal provisions related to acquisition (collection) of samples for examination in criminal proceedings. To achieve this objective, as well as justify the results, a set of general scientific and special methods is used. The comparative legal method enables to analyze the criminal procedure legislation of Ukraine and other countries, as well as the practice of the European Court of Human Rights.

View Article and Find Full Text PDF

Proficiency testing is a key component of quality assurance programs within crime laboratories and can help improve laboratory practices. However, current proficiency testing procedures contain significant limitations and can be misinterpreted by examiners and court personnel (Garrett & Mitchell, 2018). To evaluate some of these limitations, we surveyed latent print examiners (n = 198) after they completed a Collaborative Testing Services, Inc.

View Article and Find Full Text PDF

In response to research demonstrating that irrelevant contextual information can bias forensic science analyses, authorities have increasingly urged laboratories to limit analysts' access to irrelevant and potentially biasing information (Dror and Cole (2010) [3]; National Academy of Sciences (2009) [18]; President's Council of Advisors on Science and Technology (2016) [22]; UK Forensic Science Regulator (2015) [26]). However, a great challenge in implementing this reform is determining which information is task-relevant and which is task-irrelevant. In the current study, we surveyed 183 forensic analysts to examine what they consider relevant versus irrelevant in their forensic analyses.

View Article and Find Full Text PDF

Managing "incidental findings" in biobank research: Recommendations of the Taiwan biobank.

Comput Struct Biotechnol J

August 2019

Institute of Law for Science and Technology, National Tsing Hua University, Hsin-Chu, Taiwan, ROC.

Background: In this article, incidental findings (IF) refer to unforeseen findings made possible through biobanking research and advances in medical diagnostic technologies that raise issues regarding the obligation and/or responsibility of biobank-users and biobanks to return clinically significant information to participants. The World Medical Association (WMA) Declaration of Taipei (2016) highlights the possibility of encountering IF and requires that research on biospecimens address biobank feedback policies in their informed consent process, leaving open the possibility that the policy may be "no return". As clinicians and researchers begin to use these "resources", the possibility of finding clinically significant IF is becoming a reality.

View Article and Find Full Text PDF

Every scientific technique features some error, and legal standards for the admissibility of scientific evidence (e.g., Daubert v.

View Article and Find Full Text PDF

This paper comments on the views of the UN Human Rights Committee (hereafter the Committee) in the cases [1] and [2]. It focuses on the Committee's findings regarding a violation of the prohibition of discrimination. The interpretation presented by the Committee, although much welcomed and undeniably tackling reproductive health and rights in a progressive way, still leaves room for future improvements.

View Article and Find Full Text PDF

Validity Assessment in Traumatic Brain Injury Impairment and Disability Evaluations.

Phys Med Rehabil Clin N Am

August 2019

Institute of law, psychiatry and Public policy, Department of Psychiatry and Neurobehavioral Science, University of Virginia, 1230 Cedars Court, Suite 108, Charlottesville, VA 22903, USA.

This article provides an overview of validity assessment in persons with traumatic brain injury including evaluation caveats. Specific discussion is provided on post-concussive disorders, malingering, examination techniques to assess for validity, response bias, effort and non-organic/functional presentations. Examinee and examiner biases issues will also be explored.

View Article and Find Full Text PDF

Right to child health in context of natural environmental security.

Wiad Lek

August 2019

Department Of Management And Economics Of Pharmacy National Medical Academy Of Postgraduate Education Named P.L.Shupyk, Kyiv, Ukraine.

Objective: Introduction: From different points of view, health in general and child health, in particular, constitute the highest value which preserves a significant amount of resource potential. Child health is understood as his/her state consisting of a certain system of elements (physical, psychological, etc.) each of which, on the one hand, is characterized by its specificity, and on the other hand, is in a complementary relationship with each other.

View Article and Find Full Text PDF

Compassionate use of unauthorized drugs: Legal regulations and ethical challenges.

Eur J Intern Med

July 2019

Department of Clinical Immunology, Medical University of Warsaw, Nowogrodzka Str. 59, 02-006 Warsaw, Poland; Laboratory of Bacteriophages, Ludwik Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences, Rudolfa Weigla Str. 12, 53-114 Wrocław, Poland.

Compassionate use (also referred to as expanded access) is therapeutic use of unauthorized drugs outside of clinical trials. The objective of this review is to discuss practical aspects of the current legal regulations concerning compassionate use that have been introduced in the European Union, the USA (both the Food and Drug Administration regulations and Right-to-try laws), Canada and Australia. We also present main ethical challenges associated with use of unauthorized drugs such as possible difficulties with obtaining informed consent and fair patient selection.

View Article and Find Full Text PDF

[FUNCTIONAL STATUS OF THE VISUAL ORGAN DURING PREECLAMPSIA].

Georgian Med News

February 2019

Sumy State University, Medical Institute, Sumy State University, Department of Surgery and Oncology; Department of Obstetrics anf Gynecology; Academic and Research Institute of Law, Department of Administrative, Economic Law and Economic Security, Ukraine.

The purpose of this research is to study the effect of preeclampsia of pregnant women on the functional status of the visual organ. The research study was made on 77 pregnant women (154 eyes) from 17 to 43 years old. Based on the analysis of the research results, during uncomplicated pregnancy and mild preeclampsia we found no significant changes in the foveolar retinal thickness and macular retinal volume both during various trimesters of pregnancy and postpartum.

View Article and Find Full Text PDF

Emerging research documents the ways in which task-irrelevant contextual information may influence the opinions and decisions that forensic analysts reach regarding evidence (e.g., Dror and Cole, 2010; National Academy of Sciences, 2009; President's Council of Advisors on Science and Technology, 2016).

View Article and Find Full Text PDF

The European Union (EU) has adopted nano-specific provisions for cosmetics, food and biocides, among others, which include binding definitions of the term "nanomaterial". Here we take an interdisciplinary approach to analyse the respective definitions from a legal and practical perspective. Our assessment reveals that the definitions contain several ill-defined terms such as "insoluble" or "characteristic properties" and/or are missing thresholds.

View Article and Find Full Text PDF

The comparatively low adoption rate of GMO products in the European Union (EU) market seems to be connected with the strictness of authorization regulations and inefficiency of the authorization process itself. These problems will apply to any product deemed to be a GMO that could potentially be marketable in the EU. Since modern methods of plant breeding involving oligonucleotide-directed mutagenesis (ODMs) or site-directed nucleases (SDNs), including Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), are becoming ever more popular, it is crucial to establish whether the products of such new breeding techniques (NBTs), in particular those which involve precise methods of mutagenesis, are exempted from the EU legislation on GMOs or not.

View Article and Find Full Text PDF

Next Chapter of the Taiwan Biobank: Sustainability and Perspectives.

Biopreserv Biobank

April 2019

6 Ophthalmology Department, Development Center of Medical Biotechnology, National Taiwan University Hospital Hsin-Chu Branch, Hsin-Chu, Taiwan, Republic of China.

The emergence of biobanks has expanded the scope of biomedical research, ushering in an era of "precision medicine" to improve the treatment of disease. However, biobanks also face sustainability challenges comprising three dimensions-"financial," "operational," and "social." The Taiwan Biobank (TWB), as a large-scale national biobank that supplies valuable phenotypic and genetic information to biomedical researchers on an application basis to investigate the relationship among personal health, genes, lifestyle, environment and diseases of the Taiwanese population, has not been sufficiently explored by researchers.

View Article and Find Full Text PDF

Pain Management and Opioid Regulation: Continuing Public Health Challenges.

Am J Public Health

January 2019

Richard J. Bonnie is with the Institute of Law, Psychiatry and Public Policy, University of Virginia, Charlottesville. Mark A. Schumacher is with the Department of Anesthesia and Perioperative Care, University of California, San Francisco. J. David Clark is with the Department of Anesthesiology, Stanford University, Stanford, CA. Aaron S. Kesselheim is with the Program on Regulation, Therapeutics, and Law, Harvard Medical School, Cambridge, MA, and the Department of Medicine, Brigham and Women's Hospital, Boston, MA.

The still-growing US opioid epidemic lies at the intersection of two major public health challenges: reducing suffering from pain and containing the rising toll of harms associated with the use of opioids medications. Responding successfully to these challenges requires a substantial investment in surveillance and research on many fronts and a coordinated policy response by federal and state agencies and stakeholder organizations.A 2017 report of the National Academies of Sciences, Engineering and Medicine (NASEM) called for improved methods of measuring pain and the effects of alternative modalities of treatment as well as intensive surveillance of opioid-related harms; urged a long-term cultural transformation of how pain is perceived, assessed and treated; and outlined a comprehensive and balanced public health framework to guide Food and Drug Administration approval, monitoring, and review of opioids.

View Article and Find Full Text PDF

Objective: Introduction: Ukrainian counterfeit pharmaceutical market affects pharmaceutical manufacturers' image and threatens citizens' lives and health. The aim:of the article is to identify and systematize the causes and methods of pharmacy drugs' falsification, grounding the need for certain areas of counteraction.

Patients And Methods: Materials and methods: Empirical base includes Ukrainian legislation, international acts, statistical data of the WHO, State Register of Medicinal Products of Ukraine, General Prosecutor's Office of Ukraine, Unified State Register of Court Decisions, media materials, journalistic investigations.

View Article and Find Full Text PDF

A special regulatory regime applies to products of recombinant nucleic acid modifications. A ruling from the European Court of Justice has interpreted this regulatory regime in a way that it also applies to emerging mutagenesis techniques. Elsewhere regulatory progress is also ongoing.

View Article and Find Full Text PDF

Ethics codes and use of new and innovative drugs.

Br J Clin Pharmacol

March 2019

Department of Clinical Immunology, Medical University of Warsaw, Warsaw, Poland.

Treatment with new and/or innovative drugs with uncertain safety and efficacy profile is associated with substantial ethical concerns. The main objective of this paper is to present guidance on the use of such drugs contained in: (i) major international codes and guidelines pertaining to medical ethics and biomedical research; (ii) national codes of medical ethics and professional conduct of the USA, Canada, Australia, New Zealand, the UK, Ireland, France and Germany. Out of the four international codes and guidelines analysed, only the Declaration of Helsinki addresses the question of the use of unproven drugs.

View Article and Find Full Text PDF

We used an experimental design to test the key concern that expressive empathy from evaluators during forensic interviews leads to more disclosure of misbehavior (e.g., stealing, breaking the law, manipulating others) from evaluees.

View Article and Find Full Text PDF