NOTICIAS
ANVISA : Manual de Importação de Dispositivos Médicos
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...
REGULATORY MEDICAL WRITING: ” Formação útil , com excelentes exemplos “
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 ...
VALIDAÇÃO de MÉTODOS ANALÍTICOS : “Tema complexo muito bem abordado “
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...
ICH has announced plans to work on three new topics this year covering patient preference studies, non-clinical safety studies for oligonucleotide-based therapeutics and bioequivalence studies for modified release products.
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...
FDA Investigations Operations Manual 2023
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...
HEALTH ADVANCES – DIGITAL THERAPEUTIC ALLIANCE GUIDANCE TO INDUSTRY: Classification of Digital Health Technologies
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...
EUDAMED user guide Notified Bodies & Certificates . June 2023
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...
Cybersecurity and privacy in AI – Medical imaging diagnosis
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...
Content of Premarket Submissions for Device Software Functions
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...
FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing
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...
EUDAMED user guide UDI Devices Production v 2.11 . June 2023
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...
Global Unique Device Identification Database (GUDID)
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...
Boas práticas para a prevenção de ruturas de abastecimento
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...
AUDITORIA A DOSSIERS DE AIM : “Um evento dinâmico, descontraído , muito proveitoso “
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,...
BOAS PRÁTICAS de FARMACOVIGILÂNCIA: ” Formação precisa, focada e muito esclarecedora “
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,...
Progress with EU-US mutual recognition agreement for inspections for veterinary medicines
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...
FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication Information
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...
FDA final guidance clarifies whole slide imaging expectations in nonclinical toxicology studies
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...
MASTER COURSE SUPLEMENTOS ALIMENTARES: ” Evento enriquecedor , que permitiu a atualização e aprofundamento de conhecimentos”
No dia 12 de novembro teve lugar em Lisboa mais uma edição do 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...
MedTech Europe’s vision for cybersecurity in the medical technology ecosystem – position paper
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’...
Parecer 123/CNECV/2023 sobre o uso off-label de medicamentos – Implicações Éticas
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...
Validação de Limpeza : “Formação adequada, acessível, com conhecimentos técnicos e casos práticos
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...
IPEC Significant Change Guide for Pharmaceutical Excipients
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...
BPD NIVEL AVANÇADO : Uma viagem pelos 10 capítulos das GDP com relevância para os pontos mais críticos e pontuada com vários casos práticos
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...
FDA Study Data Technical Conformance Guide – Technical Specifications Document
This Guide provides technical recommendations to sponsors4 for the submission of animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs. The Guide is intended to complement and promote interactions...
GESTÃO DE RISCOS no Sistema de Gestão de Qualidade : ” Formação atual e prática de gestão de riscos”
Teve lugar no 17 de maio a formação sobre a GESTÃO DE RISCOS no Sistema de Gestão de Qualidade; uma formação exclusiva, com o objetivo de fornecer uma ocasião única de abordar a gestão de riscos no sistema de qualidade, de uma forma transversal a todo o ciclo...
ICH HARMONISED GUIDELINE GOOD CLINICAL PRACTICE (GCP) E6(R3)
Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants. Clinical trials conducted in accordance with this standard will help to assure that the rights, safety and...
AUDITORIAS e INSPEÇÃO em FARMACOVIGILÂNCIA: “Abordagem teórico-prática muito útil e equilibrada, com uma formadora especialista na área e muito experiente , recheada de casos práticos”
Decorreu no passado 17 de maio , em Lisboa, uma nova edição da formação sobre as AUDITORIAS e INSPEÇÃO em FARMACOVIGILÂNCIA, com o objetico de proporcionar aos assistentes bases sólidas, experiências práticas e conhecimentos cruciais para desenvolver as...
REGULATORY NEWS: Guidance for industry to prevent and mitigate medicine shortages
This paper focuses on proactive mechanisms to prevent shortages of medicines for human use. As patients and healthcare professionals are the main actors at the end of the supply chain, their activities in preventing shortages are usually limited to demand management...
New EMA Guidelines and Revisions in GMP Area
Publlished by https://www.gmp-compliance.org/ The European Medicines Agency (EMA) has published a new version of the "3-year work plan for the Quality domain" for the period January 2021 - December 2023. The plan is being prepared by the GMP/GDP Inspectors...
EMA: Updates PLM Portal eAF timeline (April 2023) of eAFs for Variations for Medicinal Products for Human Use
In future, submissions of #variation notifications for #medicinalproducts for human use are to be made exclusively via the electronic application forms (#eAFs). The timelines for the full implementation of these systems have now been updated again and are listed on...
EMA annual report 2022 published
EMA published its annual report 2022 today. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU). The digital report outlines the most important highlights regarding the evaluation and...
PESSOA RESPONSÁVEL COSMÉTICOS & PRODUCT INFORMATION FILE : “Esta formação foi extremamente útil e esclarecedora”
Decorreu no passado 11 de maio , a primeira edição da sessão sobre PESSOA RESPONSÁVEL COSMÉTICOS & PRODUCT INFORMATION FILE ,uma formação completa e avançada, para atualização e aprofundamento de conhecimento e competências no que diz respeito à regulamentação...
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with the AIMDD or MDD may be placed on the market or put into service until 31 December 20271 or 31...
COSMETIC CONTENT WRITING & ALEGAÇOES DE SUSTENTABILIDADE: “Formação completa e abrangente”
No dia 11 de maio de 2023 decorreu uma nova sessão formativa para a área de Cosméticos : COSMETIC CONTENT WRITING & ALEGAÇOES DE SUSTENTABILIDADE, bajo o lema "Técnicas para a escrita e Best Practices para a comunicação de conceitos de composição e...
Artificial Intelligence and Machine Learning (AI/ML) for Drug Development
What is Artificial Intelligence and Machine Learning? Artificial Intelligence (AI) and Machine Learning (ML) can be described as a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as...
Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need – Scientific guideline
This guidance summarises scientific and regulatory approaches that developers of medicines supported by EMA’s PRIME scheme can use to generate robust quality data packages for an EU marketing authorisation application, to enable patients to benefit from these...
Formação muito esclarecedora e bem estruturada , com casos práticos pertinentes
Teve lugar no dia 11 de maio uma nova edição da formação PROMOTIONAL REVIEW COMPLIANCE & BEST PRACTICES; uma excelente oportunidade de partilha de experiências entre os colegas e de revisitar alguns aspetos da legislação Nesta formação os participantes tiveram a...
Proposal for a REGULATION : HARMONISED RULES ON ARTIFICIAL INTELLIGENCE
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS This explanatory memorandum accompanies the proposal for a...
FDA Q9(R1) Quality Risk Management MAY 2023
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical...
AI Act: a step closer to the first rules on Artificial Intelligence
Once approved, they will be the world’s first rules on Artificial Intelligence MEPs include bans on biometric surveillance, emotion recognition, predictive policing AI systems Tailor-made regimes for general-purpose AI and foundation models like GPT The right to make...
EU Latest developments on AMR as part of the pharmaceutical package
IMPORTANT DOCUMENTS ON ANTIMICROBIAL RESISTANCE RELEASED TODAY BY THE EUROPEAN COMMISSION On 26 April 2023, the European Commission adopted a proposal for a Council Recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach,...
Glossary of ICH terms and definitions
This is a cumulative Glossary of terms and definitions included in the ICH guidelines, compiled from the guidelines posted at www.ich.org. Version 3, 20 April 2023 — This glossary combines the terms and definitions included in the guidelines of the International...
COMMISSION GUIDANCE on the content and structure of the summary of the clinical investigation report
This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereafter: the MDR), for the content and structure of the summary...
ISPOR – Early Scientific Advice in Europe: An Overview of Processes and Requirements
OBJECTIVES: Early scientific advice comprises a systematic process through which national Health Technology Assessment (HTA) bodies provide manufacturers with guidance on their clinical development strategy, aiming to improve the quality of evidence to be submitted....
GUIDANCE DOCUMENT Decentralized Clinical Trials for Drugs, Biological Products, and Devices .MAY 2023
This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial...
FDA PRESENTATION Submitting in eCTD: Most Common Submission Issues and FDA Plans for eCTD v4.0
Submitting in eCTD: Most Common Submission Issues and FDA Plans for eCTD v4.0: • eCTD Guidance • Most Common Reasons for Technical Rejection Notice • eCTD Validations and Study Data • Frequently Asked Questions to eSub • FDA Plans for Implementation of...
Review of transparency rules for the EU Clinical Trials Information System (CTIS)
News 03/05/2023 EMA has opened a public consultation to review the PDF icon transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to...
GUIDANCE DOCUMENT Q9(R1) Quality Risk Management. MAY 2023
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical...
Decentralized Clinical Trials for Drugs, Biological Products, and Devices
This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial...
US National Artificial Intelligence Advisory Committee (NAIAC) Year l MAY2023
For the purposes of this report, the definition of an AI system is one that was established as a best practice in the recently released NIST AI RMF: “An AI system is an engineered or machine-based system that can, for a given set of objectives, generate outputs such...