The FAERS Public Dashboard is a highly interactive web-based tool that will allow for the querying of FAERS data in a user friendly fashion. The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers.

What is FAERS?

The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA. The database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded using terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

For more information go to https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm

On Friday, December 23, the Institute of Public Health of Chile (ISP), participated in the Forum of Cooperation between Korea and Chile for the Health Industry, organized by the Embassy of the Republic of South Korea together with the Institute of Development of Korea Health Industry (KHIDI) at the Hyatt Centric hotel.
The objective of the forum was to share the current state of the pharmaceutical, cosmetic and medical devices (DM) industry, in both countries, in addition to the exchange of information among the participants to strengthen the benefits of the cooperation that exists between South Korea and Chile. .
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The South Korean authorities referred to issues of import, export and growth in medicines, cosmetics and medical devices. While the ISP referred to issues on health registration in Chile, innovation in the area of ​​cosmetics, the legal framework of medical devices and the amendment to the Health Code, known as the “Law of Drugs II.”

Source: http://www.ispch.cl/noticia/27429

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Monday, December 10, 2018, at 1pm (EDT), CDER’s Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: Biosimilar and Interchangeable Products in the U.S.: Scientific Concepts, Clinical Use, and Practical Considerations. This webinar will provide an overview of biosimilar and interchangeable products and the approval process in the U.S. This webinar will also explain the various scientific concepts used in the development of biosimilar products and the FDA’s approval standards. In addition, we will describe some practical information regarding use of these products, such as labeling, terminology, and pharmacy substitution and review the resources available to health care professionals about biosimilar and interchangeable products.

For more information go to https://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/ucm626386.htm

The Ministry of Health through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), announced the first release of 38 products with cannabis and its derivatives, which do not have THC nor cause psychoactive effects, and will be available in the Mexican market, from the next five weeks.

At the same time an awareness campaign is launched in social networks about the proper use of cannabis products and health effects, especially in children, where they will present scientific and medical details related to this type of plants.

For more information go to: https://www.gob.mx/cofepris/articulos/liberan-38-productos-con-cannabis-y-sus-derivados-182739?idiom=en

The ANMAT invites the 3rd Argentine Symposium on Good Pharmacovigilance Practices to be held on November 28 in the City of Buenos Aires. It is directed to the national and multinational pharmaceutical industry, peripheral effectors of the National Pharmacovigilance System, contract research organizations (CRO), patient organizations, health professionals, universities and students.

More information through the link https://www.argentina.gob.ar/noticias/3er-simposio-argentino-de-buenas-practicas-de-farmacovigilancia

“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