“XXX Years of Health Regulation to the Public Health Service”

The Center for the State Control of Medicines, Equipment and Medical Devices (CECMED) is pleased to invite you to participate in the 1st International Workshop on Health Products and Services Regulation, Experience in Cuba and its relationship with other authorities at a global level, to be held from 3 to April 5, 2019 at the National Hotel of Cuba, Havana, Cuba, on the occasion of commemorating the XXX anniversary of the creation of the CECMED.

This event aims to show the strengthening of Sanitary Regulation in Cuba, as well as the development of regulatory sciences in harmony with the rest of the world, so it will be a space for reflection oriented to the discussion of issues related to international regulatory trends .

For more information check our web page: www.cecmed.cu , or contact us by email eventoaniversario@cecmed.cu, Telephones: 5372164143 and 5372164384.

Source: https://www.cecmed.cu/content/1er-taller-internacional-sobre-regulacion-sanitaria-en-cuba

Within the framework of the existing cooperation between the Institute of Public Health of Chile (ISP) and the U.S. Food & Drug Administration (FDA), on November 15 authorities of both entities met at the Institute’s facilities with the aim of coordinating and defining activities of mutual interest.

The meeting was attended by Dr. María Judith Mora, Director (S) of the Institute of Public Health; Michelle Rodríguez, Ph.D., Director of the FDA Office for Latin America; Peter Baker and Gonzalo Ibáñez, representatives of the FDA in Chile. In addition, Dr. Janepsy Díaz Tito, Chief of the Departments of Scientific Affairs and Medical Devices attended; Alejandro Salinas Rivera, Head of the International Relations and Cooperation Unit; and Patricia Carmona, Head of the Sub-Department of Registration and Health Authorizations of the ISP.

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In addition, the FDA offered its collaboration to publicize its experience in the regulation of Medical Devices, an activity that will be carried out in conjunction with the Department of Medical Devices of the ISP. He also gave his support to the Institute for the development of the XIV Scientific Conference 2019, which will take place on May 14, 15 and 16, 2019 and organized by the Department of Scientific Affairs.

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At the conclusion of the meeting, the FDA expressed interest in carrying out activities with the Department of the National Agency of Medicines (ANAMED), with the purpose of identifying gaps in the accreditation process for the Pharmatheutical Inspection Co-operation Scheme (PIC / S). PIC / S is a cooperative agreement between the Health Authorities in the field of Good Manufacturing Practices (GMP). Currently PIC / S is composed of 52 authorities from all over the world, being COFEPRIS (Mexico) and ANMAT (Argentina) the only ones in Latin America.

Source: http://www.ispch.cl/noticia/27375

From November 5 to 12, ANMAT received members of the audit team of the Pharmaceutical Inspection Co-operation Scheme (PIC / S) to re-evaluate the standards of good manufacturing practices and quality systems of its inspectorate in the field of medicines.

More information by the link https://www.argentina.gob.ar/noticias/anmat-fue-reevaluada-por-el-esquema-de-cooperacion-en-inspecciones-farmaceuticas-pics

Change Can’t Wait. Our Time with Antibiotics is Running Out

Each November, World Antibiotic Awareness Week (WAAW) aims to increase global awareness of antibiotic resistance (AMR) and to encourage best practices among the general public, health workers and policy makers to avoid the further emergence and spread of antibiotic resistance. Since their discovery, antibiotics have served as the cornerstone of modern medicine. However, the persistent overuse and misuse of antibiotics in human and animal health have encouraged the emergence and spread of AMR, which occurs when microbes, such as bacteria, become resistant to the drugs used to treat them.

Key message for general public: Think twice. Seek Advice. Misuse of Antibiotics puts us all at risk.

Go to https://www.paho.org/hq/index.php?option=com_content&view=article&id=14750:world-antibiotic-awareness-week-2018&Itemid=72417&lang=en

Welcome

IX RED PARF

The Pan American Network for Regulatory Harmonization (PANDRH), is an initiative of the national regulatory authorities of the Region and the Pan American Health Organization (PAHO), which supports the process of harmonization of drug regulation in the Americas in the context of realities and national and subregional health policies and the recognition of pre-existing asymmetries.

The Pan American Conference on Harmonization of Drug Regulatory Authorities (CANDRH) , is a meeting of members of PANDRH held every two or three years and its mission is ” to promote the harmonization of drug regulation covering all aspects of quality , safety and efficacy of pharmaceutical products as a contribution to the quality of life and health care to the citizens of the countries of the Americas. ”

El Salvador becomes the headquarters of the ” IX Pan American Conference on Harmonization of Drug Regulatory Authorities (CPARF)” , to be held in San Salvador, on 24, 25 and 26 October 2018 under the theme “Celebrating 20 years the PANDRH and 40 years of Alma-Ata. Contributions regulatory harmonization in achieving health for all “

For El Salvador is honored to host an event of such importance, and be part of an initiative where they discussed technical and scientific standards and regulations related to pharmaceutical regulation processes; to have the opportunity to contribute to the harmonization of these strategies in order to ensure the health of the peoples of our America.

For more information go to https://ixcparf.medicamentos.gob.sv/index.php/en/

El Salvador is the headquarters of the VIII Meeting of Regulatory Authorities of Medicines, where the regulatory capacities regarding medical devices in the Americas will be strengthened.

The meeting takes place at the facilities of the National Directorate of Drugs, on October 22 and 23, 2018 and 23 Regulatory Authorities of the region and the Pan American Health Organization (PAHO) participate.

In the opening ceremony, the National Director of Drugs, Dr. Leonor de Acosta said that medical devices play an essential role in the public health network and are fundamental in treatments and therapies of high complexity, so that health agencies they have the challenge of ensuring that these products comply with the guarantees of quality and efficacy required to effectively benefit the health of patients.

Dr. Acosta expressed to the international delegates that: “this meeting will be a favorable space to exchange experiences in order to reduce the gaps identified in this issue, and in this way advance together in the consolidation of the regulation of medical devices in the regional and international plans “.

PAHO has intensified work in the area of ​​regulation of medical devices and in this sense has promoted the creation of a Regional Working Group for the Regulation of Medical Devices.

This working group was born in 2012, initially with 12 members, but currently has 20. Among the challenges of this meeting are: to reduce the gaps identified in the current regulation of medical devices in the Region of the Americas by proposing initiatives, strategies and cooperation groups among countries to promote the strengthening of regulatory capacities and advance their consolidation.

Source: http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/284-viii-reunion-de-device-medicines

Source: https://pressroom.oecs.org/carphacrs-and-the-organization-of-eastern-caribbean-statespharmaceutical-procurement-service-form-partnership

The director (s) of the Institute of Public Health of Chile (ISP), Dra. Judith Mora, signed on Wednesday October 10 an agreement with the Spanish Agency of medicines and health products, (AEMPS), through his representative the Dr Ramón Palop, Chief of the Management Support Unit of this organization. The objective of the agreement is to promote cooperation on products subject to sanitary control between both countries.

The agreement also seeks to promote understanding among the signatories on their respective regulatory frameworks, requirements and processes, facilitate the exchange of information and documents related to the regulation of products subject to sanitary control, promote the development of collaborative activities among signatories and improve the capacity of signatories in the provision of services related to public health, in order to meet the needs of their respective populations.

Likewise, this agreement is intended to cover all types of products regulated by both agencies and allows for significant cooperation between them. These products include medicines, cosmetics, personal hygiene and medical devices, among others.

The activities included in the framework of the cooperation itself or in the specific work project plan will be prepared by mutual agreement and with annual review, communication channels will be established to facilitate the exchange of information on the regulation of products subject to sanitary control. each signer, including: policies, practices, standards, laboratory analysis, pre-marketing evaluation, post-marketing surveillance, regulation of producers, clinical trials and products subject to sanitary control.

Source: http://www.ispch.cl/noticia/27332