Science at the Service of Public Health: Rafael Pérez Cristiá MD PhD Center for State Control of Medicines and Medical Devices.

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Cuba’s nascent biotechnology sector began making scientific breakthroughs in the 1980s, including the isolation of human leukocyte interferon alpha (1981) and the development of the world’s first safe, effective meningitis BC vaccine (1989). With positive results in hand and a growing R&D pipeline, the island nation established a national regulatory authority (NRA) to implement and oversee best practices for all pharmaceuticals and medical devices, domestically produced and imported, used in the country’s universal health system. Founded in 1989, Cuba’s Center for State Control of Medicines and Medical Devices (CECMED) is the entity charged with regulating all phases of scientific innovation for health, from clinical trial design to postmarketing surveillance.

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For more information go to: http://www.cecmed.cu/content/entrevista-de-medicc-review-director-del-cecmed-science-service-public-health-rafael-perez

The Unit of Medicines and Health Technologies of PAHO / WHO is pleased to invite you to:

Webinar: Use of REDCap for the improvement of health care processes (in Spanish)

Friday, February 16, 2018, 10:00 a.m. of Washington DC, United States

REDCap is a web software created by Paul Harris and colleagues at Vanderbilt University and designed for data management in Translational Research. With more than 10 years of development it offers a large number of features that make it attractive for researchers (multi-projects, security, surveys, randomization, branches, blind, automatic emails, access groups, user profiles, among many others). All this has led REDCap to be adopted by more than 2700 institutions, reaching almost 700,000 users in 117 countries, and has been cited in more than 4700 publications. Although the initial intention was to develop a software for Research, the use of this tool for management and operation is being increasingly validated worldwide. This presentation aims to convey the success stories of the use of REDCap for both clinical and administrative management of health care.

Cristóbal Carvajal is a surgeon, graduated from “Universidad del Desarrollo”, Santiago Chile. 5 years ago, she works in the Biomedical Informatics Department at “Clínica Alemana de Santiago”, and since 2015 she is in charge of the Clinical Data Unit. The development of its activity has been based on innovation and creative solution of problems through the use of information, so it has specialized in the modeling and data capture in different scenarios. He recently completed a stay at Quality & Improvement at the Children’s Hospital of Philadelphia, USA, which has allowed him to complement his vision of data analysis with quality aspects. Dr. Carvajal is an advanced user of the REDCap software and a pioneer in the use of this tool for purposes other than research, which has allowed him to capture information and optimize various processes in multiple scenarios. He has presented his experience in various congresses in Chile, Argentina and USA. He is an active participant in the REDCap community and a member of the Spanish-speaking group. In addition, from 2013 to the present, he works as a clinician in an Emergency Service of the “Mutual de Seguridad” (which covers accidents at work and occupational diseases).

Diego Macías Saint-Gerons has a degree in pharmacy from the University of Salamanca, a Master’s Degree in Quantitative Methods of Research in Epidemiology from the Autonomous University of Madrid and a PhD in Health Sciences from the Complutense University of Madrid. He is the author of numerous scientific articles on the use of drugs and their effects. He has worked at the University of Valladolid, the Spanish Agency for Medicines and Health Products (AEMPS), and as an expert of the European Medicines Agency (EMA). He is currently working as an international consultant (IPC) in the Medicines and Health Technologies Unit of PAHO / WHO.

Access will be provided through: https://paho.webex.com/paho/onstage/g.php?MTID=e11f25011f597fc2e8ea93b378557adc4

Additionally, it can be accessed by telephone through the United States line: + 1-415-655-0002 by dialing the access code 642 964 895

We hope count with your participation.

HSS / MT

[Original text in spanish]

The subjects of interest on the part of the Ministry of Health of Panama (MINSA) are focused on the regulation of importation of medicines, the process of issuing the marketing authorization (medicines registry), post-marketing analysis controls, and detection of counterfeit or fraudulent medicines, among other topics will be prioritized during 2018 by Invima.

For more information go to  https://www.invima.gov.co/invima-comparte-con-minsalud-de-panam%C3%A1-su-experiencia-exitosa-regulaci%C3%B3n-de-medicamentos.html

Paraguay have become the 128th member of the WHO Programme for International Drug Monitoring!

Currently, 129 countries are full members of the WHO Programme for International Drug Monitoring.

For more information about the Uppsala Monitoring Center go to https://www.who-umc.org/

Source: https://www.linkedin.com/feed/update/urn:li:activity:6359396252232273920

Monday, January 15, 2018

With the objective of strengthening the supervision of generic medicines to be of quality, safe and accessible to the population, the Minister of Health, Dr. Abel Salinas Rivas, announced that the general direction of medicines of the Ministry of Health (Minsa) will become a powerful body to regulate the pharmaceutical industry.

For more information go to http://www.minsa.gob.pe/index.asp?op=51&nota=25828

The Essential Medicines and Health Products (EMP) Department at WHO released a draft of the WHO Global Benchmarking Tool (GBT) version VI for comment by National Regulatory Authorities at the following link: http://www.who.int/medicines/regulation/benchmarking_tool/en/ .  The GBT is a means by which WHO evaluates medicine and vaccine regulatory systems through a comprehensive and systematic benchmarking process.

The revised draft GBT is the result of a collaborative effort between WHO headquarters and the WHO Regional Office for the Americas (PAHO/AMRO) with contributions from other Regional Offices and experts from national regulatory authorities. The tool builds on previous WHO NRA benchmarking tools and includes features of proven benefit such as computerization, categorization of indicators/sub-indicators and inclusion of fact sheets.

GBT draft version VI is open for comment until 28 February 2018. All comments should be sent to Dr Alireza Khadem, Scientist, Regulatory System Strengthening (RSS) team (khadembroojerdia@who.int) using the comments table available under the related links section. The draft tool is presented as consolidated indicators and fact sheets organized by regulatory function, together with a list of references and terminology used in the WHO GBT.

The 18^th International Conference of Drug Regulatory Authorities (ICDRA) is now up and running. Please see the link: http://www.icdra2018.ie/ which contains all necessary information about the Conference as well as the registration module.

The theme of the conference is: Smart Safety surveillance: A life-cycle approach to promoting safety of medical products.

The 18th ICDRA will facilitate focused discussions on quality issues, regulatory reform and strengthening regulatory systems, safety of medical products, substandard and falsified products, access, regulation of clinical trials, regulatory collaboration, harmonization, convergence and reliance, new technologies, regulation of herbal medicines, etc. It will be held in Dublin, Ireland, on  3 – 7 September 2018.

[Source in Spanish]

2018 will be a year of challenges and opportunities in terms of health regulation. COFEPRIS will promote a responsible regulatory policy that guarantees the access of Mexicans to more and better health solutions. Actions in clinical research, medical devices, innovative medicines, generics and biotechnology will be strengthened, and work will be done to reduce the gap in scientific knowledge https://www.gob.mx/cofepris/prensa/mexico-inicia-2018-como-integrante-formal-de-pic-s

Source: https://www.gob.mx/cofepris/articulos/mexico-inicia-2018-como-integrante-formal-de-pic-s-142121?idiom=es

[Source in Spanish]

As part of the official visit to Cuba of the President of Chile Michelle Bachelet and the delegation that accompanies it, a seminar “Trade and Investment Perspectives: Chile-Cuba” took place yesterday, the delegation formed by the Minister of Economy Jorge Rodríguez, the Vice Minister of Commerce of the Ministry of Foreign Affairs of Chile Paulina Nazal Aranda, the Director (S) of the Institute of Public Health of Chile (ISP) Pablo Ortíz and the Head of the Subdepartment of Registration and Health Authorizations of the ISP Patricia Carmona . In addition, representatives of the investment sector and the pharmaceutical area of Chile, as well as rectors of the most important universities in Chile.

For more information go to http://www.cecmed.cu/content/cecmed-en-seminario-perspectivas-del-comercio-e-inversiones-chile-cuba