Evolving Outsourcing Landscape in Pharma R&D: Different Collaborative Models and Factors To Consider When Choosing a Contract Research Organization.

Outsourcing has become an integral part of how research and early development (R&D) is executed in biotech companies and large pharmaceutical organizations. Drug discovery organizations can choose from several operational models when partnering with a service provider, ranging from short-term, fee-for-service (FFS)-based arrangements to more strategic full-time-equivalent (FTE)-based collaborations and even risk-sharing relationships. Clients should consider a number of criteria when deciding which contract research organization (CRO) is best positioned to help meet their goals. Besides cost, other factors such as intellectual property protection, problem solving skills, value-creation ability, communication, data integrity, safety and personnel policies, ease of communication, geography, duration of engagement, scalability of capacity, and contractual details deserve proper consideration. In the end, the success of a drug discovery partnership will depend in large part on the people who execute the science.

The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists.

Medication compounding gained national attention in the fall of 2012 after contaminated compounded medications produced in the New England Compounding Center infected 800 people with fungal meningitis and led to several fatalities. This prompted Congress to pass regulations on compounding through the Drug Quality and Security Act (DQSA) in 2013. The act increased oversight of patient-specific drug compounding taking place in compounding pharmacies, created 503(b) outsourcing facilities to obtain compounded drugs, and added regulations for obtaining compounded drugs from traditional 503(a) pharmacies. These regulations also had a broader overall impact by triggering federal and state-specific policies, which have ultimately limited a physician's ability to perform low-risk, in-office compounding. This article provides an overview of the different types of compounding restrictions, reviews the current federal and state regulations and/or guidelines, discusses how newly proposed policies may affect the practice of dermatology, and presents an algorithm on how the practicing dermatologist should approach compounding. J Drugs Dermatol. 2018;17(7 Suppl):s17-22.

Organização do trabalho de motoristas de caminhão: necessidade de uma política intersetorial / Organization of truck drivers' work: need for an intersectoral policy

A organização do trabalho de motoristas de caminhão tem se modificado intensamente nos últimos anos. Vêm sendo observados a terceirização das atividades de trabalho, o uso de escalas irregulares e longas jornadas de trabalho. As consequências da má organização de trabalho à saúde dos trabalhadores são severas, conforme demonstram diversas pesquisas científicas. Neste ensaio, discutem-se as consequências das recentes transformações ocorridas na organização de trabalho, particularmente na legislação que regulamenta as atividades de motoristas de caminhão em território nacional e a necessidade de uma política intersetorial capaz de articular as diversas políticas públicas voltadas para a proteção dessa importante categoria profissional.

The organization of truck drivers' work underwent considerable changes in recent years, with outsourcing, irregular shifts and extended working hours as some of its characteristics. Poor work organization has serious consequences for the health of workers, as shown by several scientific studies. In this essay we discuss the consequences of recent transformations in the organization of work, particularly the laws that regulate the activity of truck drivers in Brazil. We also point to the need for an intersectoral policy able to articulate the various public policies for the protection of this significant professional category

Unrestrained outsourcing in Brazil: more precarization and health risks for workers.

This article discusses the current status of outsourcing in Brazil, with new regulation underway featuring a bill of law under review by the National Congress, aimed at allowing outsourcing for all activities. The authors argue that outsourcing and precarization of work are inseparable phenomena, based on the results of 20 years of research in Brazil that reveals the more precarious working conditions of outsourced workers in different occupational categories. They focus particularly on workers' health: outsourcing of risks has led to more fatal work accidents, invariably at higher rates in outsourced workers. Finally, the article contends that to remove restraints on outsourcing in Brazil amounts to legalizing and legitimizing predatory workforce exploitation, disregarding workers' physical limits, exposing them to risk of fatal accidents, and reverting to forms of work that violate the human condition.

OUTSOURCING ETHICAL DILEMMAS: REGULATING INTERNATIONAL SURROGACY ARRANGEMENTS.

This article argues that the English legislative regime is ineffective in regulating international surrogacy, particularly with regard to commercial payments. It suggests that if English law views surrogacy as exploitative, we have a responsibility to protect women both in England and abroad, and the only way to do so effectively is to create a domestic system of regulation that caters adequately for the demand in this country. This requires a system of authorisation for surrogacy before it is undertaken; ex-post facto examinations of agreements completed in other jurisdictions, after the child is already living with the commissioning parents, cannot be seen as an acceptable compromise, as authorisation will inevitably be granted in the child's best interests.

Unrestrained outsourcing in Brazil: more precarization and health risks for workers / A terceirização sem limites: mais precarização e riscos de morte aos trabalhadores / La tercerización sin límites: más precarización y riesgos de muerte para los trabajadores

Abstract: This article discusses the current status of outsourcing in Brazil, with new regulation underway featuring a bill of law under review by the National Congress, aimed at allowing outsourcing for all activities. The authors argue that outsourcing and precarization of work are inseparable phenomena, based on the results of 20 years of research in Brazil that reveals the more precarious working conditions of outsourced workers in different occupational categories. They focus particularly on workers' health: outsourcing of risks has led to more fatal work accidents, invariably at higher rates in outsourced workers. Finally, the article contends that to remove restraints on outsourcing in Brazil amounts to legalizing and legitimizing predatory workforce exploitation, disregarding workers' physical limits, exposing them to risk of fatal accidents, and reverting to forms of work that violate the human condition.

Resumo: O artigo apresenta uma discussão sobre o quadro da terceirização hoje no Brasil, quando está em curso uma nova regulamentação por meio de um Projeto de Lei em tramitação no Congresso Nacional, que tem por objetivo liberar a terceirização para todas as atividades. Argumenta sobre a indissociabilidade entre terceirização e precarização do trabalho, com base numa sistematização de resultados de 20 anos de pesquisas no Brasil, apresentando indicadores que comprovam as condições de trabalho mais precárias dos terceirizados para diversas categorias profissionais, destacadamente para o campo da saúde do trabalhador, em que a terceirização dos riscos tem levado a um número crescente de acidentes de trabalho com vítimas fatais que têm sido invariavelmente maiores entre os trabalhadores terceirizados. Por fim, avalia que liberar a terceirização no Brasil é legalizar e legitimar o uso predatório da força de trabalho na sua forma mais aguda, desrespeitando os limites físicos dos trabalhadores, expondo-os a riscos de morte e retornando a formas pretéritas de trabalho que transgridem a condição humana.

Resumen: El artículo presenta una discusión sobre el cuadro de la tercerización hoy en Brasil, cuando está en curso una nueva regulación, a través de un Proyecto de Ley en trámite en el Congreso Nacional, que tiene por objetivo liberar la tercerización para todas las actividades. Discute sobre la indisociabilidad entre tercerización y precarización del trabajo, en base a una sistematización de resultados de 20 años de investigaciones en Brasil, presentando indicadores que comprueban las condiciones de trabajo más precarias de los tercerizados para diversas categorías profesionales, destacando el campo de la salud del trabajador, donde la tercerización de los riesgos ha llevado a un número creciente de accidentes de trabajo con víctimas fatales, que han sido invariablemente mayor entre los trabajadores tercerizados. Por fin, evalúa que liberar la tercerización en Brasil es legalizar y legitimar el uso depredatorio de la fuerza de trabajo en su forma más aguda, sin respetar los límites físicos de los trabajadores, exponiéndoles a riesgos de muerte y retornando a formas pretéritas de trabajo que transgreden la condición humana.

Standards, Regulation and Registration of Dental Laboratories. An Industry Update.

State dental associations are showing increased interest in maintaining current standards and regulations affecting the dental laboratory industry as mandated by the Food and Drug Administration. The domestic dental laboratory industry is being significantly stressed by foreign competition, rapid technology development and unprecedented consolidation, which are changing the way that prosthetic devices and restorations are manufactured and delivered to dentists. Of paramount importance to the prescribing dentist is the accurate documentation of the source and materials being used in prostheses being delivered to patients.

Regulating compounding pharmacies.

(1) The Pew Charitable Trusts identified 27 compounding incidents that resulted in 89 deaths since 2001. (2) Unlike drug manufacturers, compounding pharmacies are generally not required to report adverse events associated with their products to the FDA. (3) Federal law on drug compounding was updated in 2013 to create a new group of compounders called "outsourcing facilities." Over 50 facilities in 23 states are now registered with the FDA.

Outsourcing medical data analyses: can technology overcome legal, privacy, and confidentiality issues?

BACKGROUND: Medical data are gold mines for deriving the knowledge that could change the course of a single patient's life or even the health of the entire population. A data analyst needs to have full access to relevant data, but full access may be denied by privacy and confidentiality of medical data legal regulations, especially when the data analyst is not affiliated with the data owner. OBJECTIVE: Our first objective was to analyze the privacy and confidentiality issues and the associated regulations pertaining to medical data, and to identify technologies to properly address these issues. Our second objective was to develop a procedure to protect medical data in such a way that the outsourced analyst would be capable of doing analyses on protected data and the results would be comparable, if not the same, as if they had been done on the original data. Specifically, our hypothesis was there would not be a difference between the outsourced decision trees built on encrypted data and the ones built on original data. METHODS: Using formal definitions, we developed an algorithm to protect medical data for outsourced analyses. The algorithm was applied to publicly available datasets (N=30) from the medical and life sciences fields. The analyses were performed on the original and the protected datasets and the results of the analyses were compared. Bootstrapped paired t tests for 2 dependent samples were used to test whether the mean differences in size, number of leaves, and the accuracy of the original and the encrypted decision trees were significantly different. RESULTS: The decision trees built on encrypted data were virtually the same as those built on original data. Out of 30 datasets, 100% of the trees had identical accuracy. The size of a tree and the number of leaves was different only once (1/30, 3%, P=.19). CONCLUSIONS: The proposed algorithm encrypts a file with plain text medical data into an encrypted file with the data protected in such a way that external data analyses are still possible. The results show that the results of analyses on original and on protected data are identical or comparably similar. The approach addresses the privacy and confidentiality issues that arise with medical data and is adherent to strict legal rules in the United States and Europe regarding the processing of the medical data.

Dermatology and pathology arrangements: navigating the compliance risks.

Purchased service arrangements, establishing in-house professional pathology services, conducting technical component histology within a dermatology practice, and electronic medical records technology donations are ways that dermatology practices are responding to the current health care delivery and payment changes. This article will provide a general framework for navigating the compliance risks and structure considerations associated with these relationships between dermatologists and pathologists.