NOTICIAS

This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This guidance supersedes FDA’s guidance entitled “A Guide to Informed...

This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.  This guidance document explains, among other things: The statutory requirement to submit cosmetic product...

  The medical device Regulation (EU) 2017/745 (MDR) came into force in 2017 to supersede the MDD (Medical Device Directive) and AIMDD (Active Implantable Medical Device Directive). The development of this new regulation was focused on addressing perceived...

Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products   THE EUROPEAN COMMISSION, Having regard to the Treaty on the...

EMA News EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public...

Published by McKinsey Insights   The latest annual McKinsey Global Survey on the current state of AI confirms the explosive growth of generative AI (gen AI) tools. Less than a year after many of these tools debuted, one-third of our survey respondents say their...

Harvard Business Publishing: https://hbr.org/sponsored/2023/08/innovation-in-data-driven-health-care   Innovative uses of data in health care are helping solve the most challenging problems in patient health and operational efficiency. Today, many health care...

This document is designed to provide concrete recommendations on how to apply the TPLC to legacy devices to aid in the implementation of the framework put forward in the preceding IMDRF N60 guidance. This document is complementary to the IMDRF N60 guidance, and the...

  DOWNLOAD PDF Notified Bodies Survey on certifications and applications (MDR/IVDR

25 JULHO 2023. ORDEM  DOS FARMACÊUTICOS O Conselho do Colégio de Especialidade de Assuntos Regulamentares da Ordem dos Farmacêuticos (CCEAR-OF) atualizou o guia de Boas Práticas Regulamentares, cuja primeira edição foi publicada em março de 2004. Excetuando o capítulo...

This guidance describes a voluntary program for the qualification of medical device development tools (MDDTs) for use in the evaluation of devices regulated by CDRH.  Specifically, this guidance describes the framework for voluntary proposal and qualification of an...

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce that the CEP 2.0 will be implemented on 1 September 2023. From that date onwards, new dossier applications and renewal applications will receive a CEP 2.0, whereas...

EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public...

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices   Introduction –...

O INFARMED, I.P. pretende iniciar o projeto piloto eFI (Folheto Informativo em formato eletrónico), que consiste na retirada dos folhetos informativos em papel das embalagens de medicamentos destinadas a ser comercializadas apenas no circuito hospitalar e para...

Bold policies and increased investments in Research & Development are necessary to contribute to the success of Europe’s digital and green agenda. This can help enhance resilience and technological sovereignty, and strengthen the competitiveness of our single...

Briefing 28-06-2023 The European Commission tabled a proposal for an EU regulatory framework on artificial intelligence (AI) in April 2021. The draft AI act is the first ever attempt to enact a horizontal regulation for AI. The proposed legal framework focuses on the...

  Overview This publication presents the findings of a global horizon scan of innovations in science and technology that could help solve global health challenges.  An expert group scored over 100 innovations for their potential impact and the chance of wide...

THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives...

On the heels of the most severe pandemic in decades, European healthcare systems are facing a perfect storm of ageing populations, growing prevalence of chronic diseases, significant health workforce shortages, and the unfolding energy, climate, cost of living, and...

Scope of the Guideline To outline the practical arrangements for notification of serious breaches; this document does not cover notifications related to unexpected events, other reporting obligations related to the safety of trial participants or urgent safety...

As part of the EU Pharmaceuticals Strategy, and lessons learned from the COVID-19 pandemic, the European Commission (EC) declared its plans to assess and revise the EU’s general legislation on medicines for human use (Directive 1001/83/EC and Regulation 776/2004) to...

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The...

“Excelente formação , apresentada com muita clareza e casos práticos que serão muito úteis no dia a dia . Espaço para  questões e esclarecimento de dúvidas. Muita empatia, conhecimentos e disponibilidade da formadora. “  GILEAD   Mais uma edição da formação...

Generative AI deployment could unlock potential value equal to 2.6 to 4.5 percent of annual revenues across the pharmaceutical and medical-product industries   Our analysis finds that generative AI could have a significant impact on the pharmaceutical and...

News 23/06/2023 Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties...

The healthcare sector is grappling with critical challenges, such as a shortage of frontline workers, health disparities and escalating spending. Artificial intelligence (AI) promises transformative potential to tackle these issues.   The healthcare sector is...

  O manual tem o objetivo de orientar os importadores sobre as regras para submissão e os procedimentos de análise de processos de importação de dispositivos médicos sob responsabilidade do Posto de Anuência de Importação de Produtos para Saúde (PAFPS). Os...

Decorreu no dia 23 de junho a sessão formativa :REGULATORY MEDICAL WRITING, bajo o lema  "Técnicas base e boas práticas da escrita médica para criar documentos precisos, submission-ready, e com uma mensagem eficaz" ;  um Workshop Prático para aperfeiçoar as ...

  Teve lugar no dia 22 de junho o workshop prático : VALIDAÇÃO de MÉTODOS ANALÍTICOS   conduzido pela reconhecida especialista Dra Sandra Almeida, Responsável de Controlo de Qualidade, da  CANNAPAC Este workshop teve como objetivo oferecer um conhecimento...

Press Release: ICH Assembly Meeting, Vancouver, Canada, June 2023 20 June 2023 New Areas of Harmonisation Adopted, Alongside Significant Advancement of Ongoing Activities The Assembly of the International Council for Harmonisation (ICH) met in-person on 12 & 13...

The Investigations Operations Manual (IOM) is the primary operational reference for FDA employees who perform field activities in support of the agency’s public health mission. Accordingly, it directs the conduct of all fundamental field activities. Adherence to this...

PUBLISHED BY   healthadvances.com   HEALTH ADVANCES - DIGITAL THERAPEUTIC ALLIANCE GUIDANCE TO INDUSTRY: Classification of Digital Health Technologies June 2023 PREFACE: PROJECT CONTEXT, OVERVIEW, AND METHODOLOGY The digital transformation of healthcare is in...

The purpose of this user guide is to help you navigate through the Notified Bodies and Certificates process of registering certificates module in into EUDAMED.1 In order to successfully register a certificate in EUDAMED, this guide illustrates two scenarios including...

This report allows better assessment of the reality that artificial intelligence brings its own set of threats, which consequently insists on the search for new security measures to counter them. Finally, it should be noted that this guide strongly emphasises privacy...

This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a...

Artificial intelligence (AI) and machine learning (ML) are no longer futuristic concepts; they are now part of how we live and work. The U.S. Food and Drug Administration uses the term AI to describe a branch of computer science, statistics, and engineering that uses...

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI). The UDI-DI/Device module of EUDAMED is used for the...

The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that serves as a reference catalog for every device with a unique device identifier (UDI). GUDID contains ONLY the device identifier (DI) portion of the UDI, which serves as...

05 jun 2023 Circular Informativa n.º 052/CD/100.20.200 de 02/06/2023 A rede HMA1 e EMA2 publicaram recomendações para a indústria contendo boas práticas para assegurar a continuidade do abastecimento de medicamentos, prevenir ruturas e reduzir o seu impacto na saúde...

  Recohecendo a  alta prevalência de “inconformidades nos dossiers de AIM” nos  diferentes procedimentos quando são submetidos,.a Formiventos organizou uma nova edição da formação sobre este tema : AUDITORIA A DOSSIERS DE AIM Foi uma sessão muito enriquecedora,...

Decorreu nos passados 30 e 31 de maio uma nova edição do Seminário de actualização nas  BOAS PRÁTICAS de FARMACOVIGILÂNCIA com o objetivo de lhe oferecer uma abordagem específica dos aspetos mais críticos e actuais relacionados com a gestão da qualidade, riscos,...

Published by EMA News 31/05/2023 Today, the European Union (EU) and the United States (US) have made important progress towards enabling mutual recognition of inspections of manufacturing facilities of certain veterinary products. The Food and Drug...

Providing people with accurate and timely information to help them take their prescription medications safely and effectively is an important priority for the U.S. Food and Drug Administration. Evidence suggests that more easy-to-read information can help patients...

This guidance provides information to sponsors and nonclinical laboratories regarding the use and management of whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice (GLP)-compliant nonclinical...

No passado 30 de maio teve lugar em Lisboa mais uma edição dp MASTER COURSE   Autorização, publicidade e comercialização de SUPLEMENTOS ALIMENTARES   bajo o lema " Uma visão global dos conhecimentos imprescindíveis para fabricar, introduzir e manter-se no Mercado de...

The digital ecosystem has dramatically changed the way in which healthcare is delivered to patients. Nowadays, medical technology companies concentrate not only on ensuring the safety and security of MDs and IVDs, but also on the protection of patients’ and users’...

O Conselho Nacional de Ética para as Ciências da Vida (CNECV) analisou as implicações éticas suscitadas pelo uso off-label de medicamentos, uma prática frequente na terapêutica nos diferentes sistemas de saúde, sublinhando que existe atualmente em Portugal uma...

No dia 23 de maio de 2023 teve lugar em Lisboa, uma nova edição da formação sobre  Validação de Limpeza, bajo o lema : Técnicas para desenhar a sua estratégia de validação que garanta os melhores resultados em termos de produtividade , segurança, ergonomia e proteção...

The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces the availability of the updated IPEC Significant Change Guide for Pharmaceutical Excipients (Version 5, 2023). The guide was originally published in 2000 as an IPEC-Americas...

Teve lugar uma nova edição da formação exclusiva da Formiventos, sobre GDP Nível 2 : BOAS PRÁTICAS DE DISTRIBUIÇÃO Nível Avançado; uma sessão para profissionais  com experiência consolidada em ambiente GDP, que pretendem  uma formação de refreshing  nas Boas Práticas...