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Webinar: regulation of advanced therapy products [in Portuguese]

[Original text in Portuguese]

Online event will introduce the regulatory concepts for advanced therapy products and Anvisa’s perspectives to the topic.

By: Ascom / Anvisa

Posted: 03/16/2018 11:39

Last Modified: 03/19/2018 08:50

Anvisa will hold a webinar on advanced therapy products next week. These therapies involve products of cellular therapies, technology that use human cells, among others. The event will take place on March 22, at 3:00 p.m.

During the webinar, the Blood, Tissues, Cells and Organs Department will give a presentation on the topic and answer participants’ questions about the regulation of the sector.

The webinar is an online webcast conference where participants can interact through a messaging service, such as a chat, and send questions to the technical panel. The talk transmitted is stored on the Agency’s website and can be accessed at other times for the correction of doubts.

How to participate

To participate, just access the link below on March 22 at 15h.

Link to access event: Regulation of Advanced Therapy Products

The webinar is an initiative of Anvisa’s Knowledge Management area and aims to strengthen the Agency’s active transparency initiatives, bringing updated knowledge to the external public.

Want to know Anvisa news first hand? Follow us on Twitter @anvisa_oficial and Facebook @AnvisaOficial

Source: http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4170985

 

 

 

 
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Directora de la OPS presenta en Brasil panorama de la medicina tradicional en las Américas

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.

(…)

For more information go to 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

 
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WHO PUBLIC CONSULTATION: CALL FOR COMMENTS ON GUIDELINES FOR THE SAFE PRODUCTION AND QUALITY CONTROL OF POLIOMYELITIS VACCINE

The WHO Regulatory Standards for Vaccines and Biologicals unit opened a public consultation for regulators, manufacturers and other experts. The following document has been posted on the WHO biologicals web site http://www.who.int/biologicals/en/ for public comments:

  1. Guidelines for the safe production and quality control of poliomyelitis vaccine

http://www.who.int/biologicals/WHO_Safe_production_of_Polio_1st_PC_6_March_2018.pdf?ua=1

  1. Comment Form http://www.who.int/entity/biologicals/Comment_Form_POLIO_6_March_2018.doc?ua=1

DEADLINE for submission of comments: 04 April 2018

 
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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines

February 26, 2018

The current influenza season has been especially difficult, causing widespread illness that has affected all fifty states and resulted in a record number of hospitalizations. While healthcare professionals continue to combat this year’s flu – which may continue to affect Americans into April – we’re already partnering with other public health agencies to conduct essential work to produce next season’s influenza vaccines.

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For more information go to https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm598317.htm

 
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ANVISA: Workshop on Clinical Evaluation of Medical Devices registration is now open

[Original in Portuguese]

The event, which will deal with Clinical Assessment of Medical Devices, will take place at the Agency’s headquarters on March 27th.

On March 27, Anvisa will host the workshop on Clinical Evaluation of Medical Devices. The event, which will begin at 9:00 am in the auditorium of the Agency, counts on the partnership of the Brazilian Association of the Industry of Articles and Medical, Dental, Hospital and Laboratories (Abimo), Brazilian Association of the High Technology Product Industry for Health (Abimed) and the Brazilian Association of Importers and Distributors of Health Products (Abraidi).
The workshop aims to disseminate knowledge and improve processes and practices through the sharing of national and international experiences and the identification of difficulties and challenges related to the theme.

For more information go to http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4085408 

 
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The Global Cancer Clinical Research, Drug Development and Therapeutic Accessibility Workshop

April 30 – May 1, 2018

The Global Cancer Clinical Research, Drug Development and Therapeutic Accessibility Workshop is a collaborative effort between the Duke University Center for Applied Therapeutics and the National Cancer Institute’s Center for Global Health.

The availability of new cancer treatments varies widely around the world. This workshop will focus on the clinical testing and development, regulatory approval, and access to/reimbursement for anticancer drug activity that occurs internationally. It will deal with the complex issues specific to international oncology drug development, focusing on molecular subtypes of cancer, rare cancers and pediatric cancers.

The Workshop aims to develop research networks to facilitate collaboration and increase efforts to reduce the global burden of cancer.

For more information go to https://www.globalcancerdrugdevelopment.org/

 
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PAHO will support Dominican Republic public health system

[Original text in Spanish]

President Danilo Medina received today the visit of the director of the Pan American Health Organization (PAHO), Carissa Etienne, in which they discussed the progress and challenges of the health sector in the Dominican Republic.

Along with Etienne, was Alma Morales Salinas who, on behalf of the director of PAHO, explained the interest of that organization in supporting the public health system of the country, making available technical cooperation to address noncommunicable diseases.

He also said that PAHO will support the Dominican Republic in what it requires for the development of the health city within the framework of strengthening the integrated health service networks.

The meeting was framed in the meeting of managers of the PAHO sub-region, as well as the subregion of Central America, Cuba, Mexico and the Dominican Republic and heads of departments of the regional headquarters of that organization.

For more information go to: https://presidencia.gob.do/noticias/salud-grandes-avances-y-retos-ops-apoyara-sistema-de-salud-publica-y-9-1-1

 
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President Tabaré Vázquez of Uruguay is a co-chair of The WHO Independent Global High-level Commission on noncommunicable diseases

16 February 2018 | Geneva – WHO is announcing today a new high-level commission, comprised of heads of state and ministers, leaders in health and development and entrepreneurs. The group will propose bold and innovative solutions to accelerate prevention and control of the leading killers on the planet – noncommunicable diseases (NCDs) like heart and lung disease, cancers, and diabetes.

The WHO Independent Global High-level Commission on NCDs is co-chaired by President Tabaré Vázquez of Uruguay; President Maithripala Sirisena of Sri Lanka; President Sauli Niinistö of Finland; Veronika Skvortsova, Minister of Healthcare of the Russian Federation; and Sania Nishtar, former Federal Minister of Pakistan.

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The new Commission was established by WHO Director-General Dr Tedros Adhanom Ghebreyesus and runs until October 2019. It will provide actionable recommendations to contribute to the Third United Nations General Assembly High-level Meeting on NCDs scheduled for the second half of 2018. This will include the submission of its first report to Dr Tedros in early June.

(…)

For more information go to http://www.who.int/mediacentre/news/releases/2018/world-leaders-ncds/en/

 
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Mexico promotes opportunities for expansion and access to the pharmaceutical and medical device market

As part of the strategy to strengthen links at a global level, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) participated in the work of India Pharma 2018, where it presented the regulatory advances reported by Mexico to expedite the population’s access to medicines and supplies for quality, safety and efficacy.

For more information go to https://www.gob.mx/cofepris/articulos/fortalece-la-cofepris-vinculos-internacionales-147624?idiom=es