Quinta-feira, 5 de abril, 2:30pm EDT
As discussoões serão sobre a atualização das formas de participação no ICH e a criação do International Pharmaceutical Regulators Programme – IPRP.
Para conexção: goo.gl/29jDra
Esperamos contar con sua participação.
Secretariado PARF.
10th Annual PQT Medicines Quality Assessment Training
Copenhagen, Denmark – 28 – 31 May 2018
The 10th Annual Prequalification Team: Medicines (PQTm) (formerly Prequalification of Medicines Programme) quality assessment training will take place in Copenhagen, Denmark during 28‒31 May 2018. The location will be at the Phoenix Hotel (Copenhagen).
The course will focus on the quality aspects of assessment of a generic product dossier (APIs and FPPs) as submitted to PQTm, but will also cover bioequivalence and biowaiver issues, as well as product information and labelling considerations (see draft programme). The training will provide practical examples and solutions for common assessment issues. Participants are expected to have the Model Dossier training tool downloaded on their laptops for practical exercises.
The training is aimed at regulators from national medicines regulatory authorities (NMRAs) in emerging markets, and primarily quality assessors. The speakers/mentors are senior assessors in PQTm.
Breakout sessions will also be included in which issues brought forward by the participants can be discussed in a smaller group with one of the trainers.
If several regulators from the same agency wish to participate, priority will be given to those who have not previously participated. A maximum of two people per NMRA will be accepted for the course.
If you are interested in attending this training, please obtain your NMRA’s written approval as soon as possible, and attach it together with a CV in an email to Dr Matthias Stahl at stahlm@who.intno later than Friday, 23 March 2018. The number of places is limited and a separate confirmation whether you have been chosen to participate in the training will be sent out in due course.
Related Links
Source: https://extranet.who.int/prequal/events/10th-annual-pqt-medicines-quality-assessment-training
The Ministry of Health is advising the public against the use of unregistered Cannabis Products for medical and therapeutic purposes.
The Ministry of Health recommends that Medical Cannabis products have a maximum Tetrahydrocannabinol (THC) content of 5% and is concerned about the potential negative public health effects that may arise from the use of unregistered cannabis products of which the (THC) content is unknown. Tetrahydrocannabinol (THC) is the main mind-altering ingredient found in the Cannabis plant.
According to the Foodand Drugs Act, any substance manufactured, sold or represented for use in the diagnosis, treatment, prevention of a disease, disorder or symptoms is classified as a drug and must be registered, and the requisite permits obtained from the Ministry of Health.
Additionally, the Dangerous Drugs (Amendment) Act, 2015 which has decriminalized ganja for specific purposes, cannabis remains classified as a controlled drug under the Food and Drugs Act (1975). Also, in accordance with the provisions of the Pharmacy Act, the compounding, dispensing, storing for sale or retailing of drugs must be done at a registered pharmacy and by a registered pharmacist. Therefore, any company that is currently selling cannabis products for medical and therapeutic purposes is in breach of The Food and Drugs Act (1975) and The Pharmacy Act.
Companies are being advised to consult with the Ministry of Health’s Standards and Regulations Department, Pharmacy Council of Jamaica and the Cannabis Licensing Authority if they wish to manufacture or distribute cannabis products, to ensure that proper standards and procedures are followed and that their operations are in keeping with the relevant laws of Jamaica.
There is a process in place for registration of Medical and Therapeutic Cannabis Product that starts with the application for registration by the Ministry of Health.
The Ministry of Health wishes to reiterate that it does not support, for medicinal and therapeutic purposes, the smoking of cannabis and the use of edibles containing cannabis.
Use of Big Health Care Data for Clinical Research
Each session’s topic seeks to promote an exchange of knowledge and experiences amongst participants, and to inspire new lines of research across borders.
The speakers are prestigious professors who have extensive teaching and research experience and whose work has been widely published in their respective fields. Sessions are structured around the presentation of articles, case studies, and work of the speakers themselves, presenting reviews of their work and the current state of issues involved.
*Sessions are conducted in English and require active participation of all attendees. Required readings are also in English. For more details or questions, write to: iap.symposia@uam.es
When: July 23-27, 2018
Where: 29 Oxford Street. Cambridge, MA 02138
Participation Fee: 1,500 USD*
* Fee includes: tuition, curricular materials, and some meals.
Scholarships: A limited number of partial scholarships and full scholarships are available. For partial scholarship recipients IAP will cover 40% of the participation fee (600 USD), and the cost for the recipient will be 900 USD. To apply for a scholarship, please explain in your cover letter in the application form a) your interest in attending the program and b) your reasons for requesting a scholarship.
For more information go to http://www.uam.es/otros/rccdr/clinical-research-program.html
Tenemos el agrado de invitarlos a la 21ra edición del programa de Webinars de RedETSA, el próximo miércoles, 28 de marzo, a las 11hs, horario de Washington DC.
El Dr. Sebastián García Martí, coordinador del departamento de EE y ETS del Instituto de Efectividad Clínica y Sanitaria (IECS), de Argentina, dará una presentación sobre “Revisiones rápidas y Evaluación de Tecnologías Sanitarias”.
El link de WebEx que utilizaremos es el siguiente: https://goo.gl/vpiiWu
Por favor, siéntanse libres de difundir esta invitación a todos aquellos a quienes pueda serles de interés.
Enviamos más abajo una tabla con el horario correspondiente a cada país.
Contamos con su presencia.
Saludos cordiales,
Secretariado RedETSA
La Paz – Lunes 26 de Marzo de 2018 | Unidad de Comunicación
El trámite para la importación de medicamentos oncológicos dura 10 días, en el caso de ser refrigerados concluye en 24 horas, informó la directora General Ejecutiva de la Agencia Estatal de Medicamentos y Tecnologías en Salud, María Carrasco.
“Este trámite debe concluir en el lapso de 10 días, a diferencia de otros productos farmacéuticos que por norma duran 30 días”, explicó la autoridad.
De acuerdo con la Ley del Medicamento N. 1737, aprobada en 1996, todos los productos deben cumplir requisitos como el registro sanitario vigente, importación, autorizaciones para despacho aduanero, entre otros.
En Bolivia, los fármacos para tratar el cáncer figuran en el Listado Nacional de Medicamentos Esenciales (Liname), por tanto en la gestión 2017 la Agemed amplió de 38 a 54 los tipos de productos importados.
“Si el medicamento viene refrigerado, ese despacho aduanero se aprueba en 24 horas, normalmente este trámite se extiende por cinco días, pero nosotros buscamos facilitar su acceso a la población”, remarcó.
Denuncias
Actualmente, la dirección de la Agemed no recibió denuncias por desabastecimiento de medicamentos oncológicos en el país.
“Existen 24 empresas habilitadas para la importación de estos fármacos y hasta el momento ninguno manifestó problemas o demoras en sus trámites”, dijo Carrasco.
En ese marco, pidió a los pacientes, establecimientos de salud e instituciones denunciar ante los Servicios Departamentales de Salud (Sedes) y a la propia Agemed alguna carencia o desabastecimiento de estos fármacos, para proceder con la investigación correspondiente.
NES/
Evento on-line vai apresentar os conceitos regulatórios para os produtos de terapias avançadas e as perspectivas da Anvisa para o tema.
Por: Ascom/Anvisa
Publicado: 16/03/2018 11:39
Última Modificação: 19/03/2018 08:50
A Anvisa realiza na próxima semana um webinar sobre produtos de terapias avançadas. Essas terapias envolvem produtos de terapias celulares, tecnologia que utilizam células humanas, entre outras. O evento acontece no dia 22 de março, às 15h.
Durante o webinar, a Gerência de Sangue, Tecidos, Células e Órgãos fará uma apresentação sobre o tema e responderá perguntas dos participantes sobre a regulação do setor.
O webinar é uma conferência virtual transmitida pela internet e na qual os participantes podem interagir por meio de um serviço de mensagens, como um chat, e enviar perguntas à área técnica palestrante. A palestra transmitida fica arquivada no portal da Agência e pode ser acessada em outros momentos, para o saneamento de dúvidas.
Para participar, basta acessar o link abaixo no dia 22 de março às 15h.
Link para acesso ao evento: Regulação de Produtos de Terapias Avançadas
O webinar é uma iniciativa da área de Gestão do Conhecimento da Anvisa e visa fortalecer as iniciativas de transparência ativa da Agência, levando conhecimento atualizado ao público externo.
Quer saber as notícias da Anvisa em primeira mão? Siga-nos no Twitter @anvisa_oficial e Facebook @AnvisaOficial
Fonte: http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4170985
13th March 2018
Drug Alert No. 1/2018
Dayamineral ® 240ml Syrup
The Ministry of Health would like to inform the public on unauthorized and suspected falsified Dayamineral ® Syrup 240ml bottle that has been found to be circulating the market and has been confiscated. Investigations conducted by the Ministry are indicative that this Dayamineral Syrup found has not been granted entry into the country by the Ministry of Health and the quality may be compromised.
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For more information go to http://health.gov.bz/www/attachments/article/978/Alert%20No1-2018.pdf
Río de Janeiro, Brasil, 12 de marzo de 2018 (OPS/OMS)– La directora de la Organización Panamericana de la Salud (OPS), Carissa F. Etienne, presentó un panorama sobre la medicina tradicional en la región de las Américas, durante la apertura del 1º Congreso Internacional de Prácticas Integrativas y Salud Pública, que se desarrolla hasta el jueves en Río de Janeiro.
“Acelerar los esfuerzos de los países para lograr la salud universal en 2030 – como se comprometió el mundo en la nueva Agenda de Desarrollo Sostenible – requiere escuchar las voces de las personas, prestar atención a las múltiples formas de entender el mundo en que vivimos, las múltiples culturas y tradiciones, incluida su medicina tradicional”, afirmó Etienne.
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Mais informações pelo link http://www.paho.org/hq/index.php?option=com_content&view=article&id=14186%3Adirectora-de-la-ops-presenta-en-brasil-panorama-de-la-medicina-tradicional-en-las-americas&catid=1443%3Aweb-bulletins&Itemid=135&lang=en
Un total de seis alertas sanitarias ha emitido el Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima) en el último año sobre el producto Vitacerebrina Francesa, el cual no tiene registro sanitario, por lo cual su comercialización en Colombia es ilegal y se considera fraudulento.
Al desconocerse su composición, este producto puede contener sustancias que afectan la salud e incluso comprometan la vida de quienes lo consumen, por lo cual se ha recomendado a las personas no consumirlo y denunciar los lugares donde es comercializado.
Este producto también se vende bajo varios nombres similares como: Mega Vitacerebrina o Mega Max Vitacerebrina Francesa y usan registros sanitarios falsos para engañar a las personas y hacerles creer que son productos legales. Algunos ejemplos de registros falsos: RSAD12L01632, RSAD15I25638, RSAE 12I11504.
Estos productos son promocionados como alimentos con propiedades medicinales que prometen mejorar el coeficiente intelectual, dar vitalidad, energía y curar enfermedades del hígado, riñones, corazón y hasta el cáncer de mama, según lo publicitan en sus empaques.
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Más informaciones por el enlace: https://www.invima.gov.co/%C2%A1ojo%C2%A1,-vitacerebrina-francesa-es-un-producto-fraudulento.html
