Murilo Freitas - 14:47, 17 de September de 20182,094
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The ANMAT and the Ministry of Health of Mexico, through its Federal Commission for the Protection against Sanitary Risks (Cofepris), signed an inter-institutional agreement on inspection records.
The objective is to facilitate cooperation in the exchange of inspection records in the pharmaceutical industry to “promote the development of a unified mechanism for the validation of inspections to verify compliance with Good Manufacturing Practices for Medicines”.
This agreement is part of the fulfillment of the commitments assumed in 2012 by the National Regulatory Authorities of Regional Reference to implement mechanisms for the exchange of inspection reports on Good Manufacturing Practices.
The Office of the Prosecutor General of the Nation (FGN) captured 14 people (12 Invima officials, 1 intermediary and 1 businesswoman) for allegedly managing and issuing health records with false documents, marketing confiscated products, altering or disappearing sanctions and conducting non-formal prior audits that supposedly guaranteed to overcome with success the official inspections that the Institute does.
These captures are the result of an investigation initiated by the FGN in 2016 thanks to the complaints presented by the General Directory of Invima. The Director General of Invima, Dr. Javier Humberto Guzmán Cruz, and the Attorney General of the Nation Doctor Nestor Humberto Martinez, made the case known to the country at a press conference on August 29, 2018.
Murilo Freitas - 13:11, 4 de September de 20181,332
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The Honduran Delegation had technical meetings, during three days, to know the organization, normativity, operation and results of the COFEPRIS.
The Honduran Delegation, during three days of this week, had technical meetings to know the organization, normativity, operation and results of the COFEPRIS; They visited the Commission for Analytical Control and Extension of Coverage (CCAyAC) where they learned about the various analytical processes, resolutions and technical opinions for food, medicines and medical devices.
The Federal Commissioner, Julio Sánchez and Tépoz, received the Honduran delegation in their offices, and spoke to them about the strengthening of the Mexican regulatory system and that COFEPRIS, being a National Level IV Reference Agency, is mandated to support the strengthening of other regulatory authorities. He also commented on the international programs of PAHO / WHO that they can access to modernize their operation for protection against health risks.
It was agreed to define a work plan for the implementation of recommendations in the ARSA by COFEPRIS, establish direct communication channels between both regulatory agencies and work on a collaborative instrument to formalize and promote cooperation ties.
On the evening of 18th September 2017, a merciless Maria passed over Dominica as a Category 5 hurricane, striking with winds in excess of 175 miles per hour, reshaped Dominica’s social, physical and economic landscape and threaten the future viability as a nation.
Currently, the Government has presented on July 2018 The National Budget Of The Commonwealth of Dominica Fiscal Year 2018 – 2019, “From Survival, To Sustainability And Success: A Resilient Dominica”.
This important document addressed that the Ministry of Health and Social Service will focus on the seven (7) pillars of World Health Organization (WHO)/Pan American Health Organization (PAHO) which capture the building blocks for health systems strengthening. These are service delivery, health workforce, health information system, access to essential medicine, financing, leadership/governance and community participation.
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 Tuesday, September 18, 2018, at 1:00PM (EDT), CDER’s Office of Communication, Division of Drug Information (DDI) will host a webinar titled: FDA Drug Topics: Building Confidence in Generic Narrow Therapeutic Index (NTI) Drugs. This webinar will introduce the general characteristics of Narrow Therapeutic Index or NTI drugs and discuss FDA’s innovative approach and criteria for generic NTI drug equivalence evaluation. In addition, we will discuss results from a bioequivalence study comparing brand and generic tacrolimus (an NTI drug) capsules in stable transplant patients to address patients’ and health practitioners’ questions regarding substitutability of generic immunosuppressant drugs.
The Ministry of Health of Uruguay publishes a modification of the Therapeutic Drug Formulary that adds treatment of retinitis due to cytomegalovirus in patients with HIV infection to the VALGANCICLOVIR medicines coverage plan and incorporates the treatment of patients with Hepatitis virus infection C for the association of SOFOSBUVIR + VELPATASVIR.
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São Paulo é responsável por cerca de metade das doações de órgãos
Anvisa, in partnership with the Sírio Libanês Hospital, held the 16th National Meeting of the Sentinel Network – Experiencing Innovation for Patient Safety. The event, which took place in São Paulo, Brazil, from 7 to 9 August, was attended by about 350 of almost all the hospitals that make up the Sentinela Network.
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Sentinel Network
The Sentinel Network is made up of partners from about 250 hospitals that, since 2002, subsidize the National Health Surveillance System (SNVS) with reports of adverse events and technical complaints regarding the use of health products, medicines, blood and blood products. The 16th National Meeting of the Sentinela Network brought together professionals from various health areas who work with risk management and patient safety.
In recent years, there has been a dramatic increase in the level of interconnectedness and data exchange between medical devices and their network environments. Increased connectivity in medical devices can: improve access to health care information; facilitate more timely diagnoses and treatments; and, improve access to care for patients. However, it can leave medical devices vulnerable to unauthorized access in a manner similar to computer systems. These vulnerabilities can impact the safety of the medical device by affecting clinical operations, causing diagnostic errors, or causing direct harm to patients.
The Ministry of Public Health and the Pan American Health Organization / World Health Organization (PAHO / WHO) held a meeting this Monday to follow up on the construction progress of the Santo Domingo Blood Donor Center.
At the meeting, Dr. Rafael Sánchez Cárdenas, Minister of Health and Alma Morales Salinas, representing the PAHO / WHO, explained that the final touches are being put to put into operation the Blood Donor Center that will come to supply the needs and the blood deficit existing in the country.
