Biosimilar medicines in dermatology: key aspects.

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A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates

Background: Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. The objective of this work was to identify the major criteria considered necessary for selecting neonatal intensive care units that are able to perform drug evaluations competently. Methodology and Main Findings: This Delphi process was conducted with an international multidisciplinary panel of 25 experts from 13 countries, selected to be part of two committees (a scientific committee and an expert committee), in order to validate criteria required to perform drug evaluation in neonates. Eighty six items were initially selected and classified under 7 headings: "NICUs description - Level of care'' (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience'' (12), "Scientific competencies and area of expertise'' (8), "Quality Management'' (16), "Training and educational capacity'' (8) and "Public involvement'' (6). Sixty-one items were retained and headings were rearranged after the first round, 34 were selected after the second round. A third round was required to validate 13 additional items. The final set includes 47 items divided under 5 headings. Conclusion: A set of 47 relevant criteria will help to NICUs that want to implement, conduct or participate in drug trials within a neonatal network identify important issues to be aware of. Summary Points: 1) Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. 2) The present Delphi study was conducted with an international multidisciplinary panel of 25 experts from 13 countries and aims to identify the major criteria considered necessary for selecting neonatal intensive care units (NICUs) that are able to perform drug evaluations competently. 3) Of the 86 items initially selected and classified under 7 headings - "NICUs description - Level of care'' (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience'' (12), "Scientific competencies and area of expertise'' (8), "Quality Management'' (16), "Training and educational capacity'' (8) and "Public involvement'' (6) - 47 items were selected following a three rounds Delphi process. 4) The present consensus will help NICUs to implement, conduct or participate in drug trials within a neonatal network.

El ADPIC y la corrupción de la industria farmacéutica: el acceso a los medicamentos en los países del Norte y del Sur

Resumen (Castellano): El acceso a los medicamentos ha sido en las últimas décadas un tema a debatir tanto en los países del Sur como en los países del Norte. Los precios impuestos por la industria farmacéutica para enfermedades tan graves como el VIH-SIDA han sido excesivos y consecuentemente inalcanzables para los países más pobres. Sin embargo, actualmente los países más ricos del Norte están sufriendo estas mismas consecuencias a causa del nuevo tratamiento contra la hepatitis C, cuyos precios astronómicos han excluido a numerosos enfermos del acceso al mismo. El derecho humano a la salud está siendo vulnerado, y las principales responsables son las empresas farmacéuticas, las cuales han corrompido los sistemas de salud. La fijación de precios monopólicos, tras el fortalecimiento de las patentes farmacéuticas con la firma del Acuerdo sobre Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC), ha constituido un obstáculo para la realización del mismo, agrandado por las disposiciones ADPIC-plus incluidas en los tratados de libre comercio . No obstante, la consolidación de la industria de medicamentos genéricos ha logrado competir contra ellas, suministrando medicamentos asequibles y promoviendo los intereses de los más necesitados.

MW, Medical Watches

My project is a business plan about the set up of a company and the development of a new and innovative product aimed for the elders. I decide do this project when I discover that one of the more important needs that have the elders is to remember the medicines that they have to take. I thought that a good way could be through a smart watch. My watch have an only function, is a cheap device, easy to use, easy to understand and easy to set up, because the elders usually do not know to use complex electronics devices. There are other similar smart watches and other devices but do not have the necessary characteristics to be a good reminder for elders. My watch is centred to improve the life of the elders, but my product could also be useful for ill people who have to take many medicines during the day. After realizing this business plan, I have proved that my company is viable in the environment and profitable in the market.

Zientzien irakaskuntza: argumentazio gaitasuna sustatzeko proposamena, sendagaien ezagupenaren bidez

[eus] Gaur egun, aditu desberdinek diotenez, Lehen Hezkuntzan konpetentzia zientifikoa garatzeko zailtasunak daude . Egoera hobetzeko, kultura zientifikoan murgiltzeko aukera, eta argumentazio gaitasuna garatzeko aukera eskaini behar zaie ikasleei. Esku-hartze honetan, eztabaida soziozientifikoen bidez, argumentazio gaitasuna lantzen da, sendagaien eraginkortasuna eta efektu sekundarioen arteko harremana eztabaidagai izanik. Esku-hartzea burutzean, ikusi ahal izan da adin txikiko ikasleak, aukera eskaintzen zaienean, argumentu justifikatuak emateko gai izan direla konpetentzia zientifikoa lortzeko bidea eraikiz. Aldi berean, sendagaien eraginkortasunaren eta efektu sekundarioen arteko harremanaz ohartu dira.