NOTICIAS
ICH releases draft guideline proposing harmonized bioequivalence testing
Objective This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic...
FDA GUIDANCE. M11 CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL.
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE: CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL. The clinical protocol describes the processes and procedures directing the conduct...
RECOMMENDATION PAPER ON DECENTRALISED ELEMENTS IN CLINICAL TRIALS
The recommendation paper will address the roles and responsibilities of the sponsor and investigator, electronic informed consent, IMP delivery, trial related procedures at home, data management and monitoring in a decentralised clinical trial setting. An overview of...
Functional specifications for the European Database on Medical Devices (EUDAMED) – to be audited
Functional specifications for the European Database on Medical Devices (EUDAMED) - to be audited (only for Minimum Viable Product (MVP) Legal Priority) Consolidated version of functional specifications for EUDAMED (version 7.2)
MDCG 2022-4 rev.1 – Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions – devices covered by MDD or AIMDD certificates – December 2022
This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120(3) second subparagraph MDR. In order to clarify elements to be verified by notified bodies, this guidance document...
GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (EU) 2017/745 (MDR). December 2022
EU MDR News!! (PSUR Guidance) MDCG 2022- 2021 GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (EU) 2017/745 (MDR) December 2022. This guidance is applicable to medical devices which have been certified under the MDR and to devices which...
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 – Version2 – December 2022
Determining whether a given product falls under the definition of a medical device and the application of the classification rules fall within the competence of the authorities of the Member States where the product is on the market. However, when different...
MDCG 2022-20 – Substantial modification of performance study under Regulation (EU) 2017/746 – December 2022
The sponsor of a performance study is required to submit an application/notification to the Member State(s) in which a performance study is to be conducted, accompanied by the documentation referred to in Chapter I of Annex XIV of Regulation (EU) 2017/746 on in...
New Version of GMP, GCP and GDP Data Governance and Data Integrity Guide available
The ECA Foundation just published version 3.0 of the GMP, GCP and GDP Data Governance and Data Integrity Guide. This very comprehensive document was prepared by the experts of the ECA Analytical Quality Control Group and the Data Integrity & IT Compliance Group in...
MDCG 2020-19 Performance study application/notification documents under Regulation (EU) 2017/746
The sponsor of a performance study is required to submit an application/notification to the Member State(s) in which a performance study is to be conducted, accompanied by the documentation referred to in Chapter I of Annex XIV of Regulation (EU) 2017/746 on in vitro...
REPORT ON RISKS AND BENEFITS TO HEALTH OF NON-DEVICE SOFTWARE FUNCTIONS
Section 3060(a) of the 21st Century Cures Act (herein referred to as the Cures Act), enacted on December 13, 2016 (Pub. L. 114-255), amended the Federal Food, Drug, and Cosmetic Act (herein referred to as the FD&C Act) to exclude certain medical software functions...
3ª edição da sessão interativa sobre MARKETING DIGITAL: “Extremamente útil “
No dia 6 de dezembro, decorreu mais uma edição da formação exclusiva da Formiventos sobre MARKETING DIGITAL: Promotional Review Compliance, conduzida pela reconhecida especialista Dra Raquel Miguéis, Regulatory Affairs Senior Officer, da OWL PHARMA CONSULTING Os...
Formação em AUDITORIA DE FARMACOVIGILÂNCIA : “Conteúdo de extrema importância muito bem apresentado e muito útil”
No dia 6 de dezembro teve lugar uma nova edição da formação sobre AUDITORIAS e INSPEÇÃO em FARMACOVIGILÂNCIA, bajo o lema " Proporcionar aos assistentes bases sólidas, experiências práticas e conhecimentos cruciais para desenvolver as auditorias; estar preparado...
Autorização de Importação Paralela: revisão do procedimento
Publicado por INFARMED . www.infarmed.pt 07 dez 2022 Circular Informativa n.º 144/CD/100.20.200 de 07/12/2022 Conforme previsto no Estatuto do Medicamento, a Autorização de Importação Paralela (AIP) permite a comercialização de um medicamento...
MDCG 2022-17 : MDCG position paper on ‘hybrid audits’
This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It...
Regulatory Horizons Council: The regulation of Artificial Intelligence as a Medical Device
An independent report to government from the Regulatory Horizons Council about the regulation of AI as a Medical Device. The Regulatory Horizons Council (RHC) is an independent expert committee that identifies the implications of technological innovation, and...
EU MDR News : MDR implementation .Extension proposal
EU Commission after listening to the different parties is now open to an extension of the transitional period with staggered deadlines depending on the product class. - 2027 for class III and IIb - 2028 for class IIa and I (upclassified) Update regarding the...
ICH adopts Q13 guideline on continuous manufacturing
Objective This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification...
Statistical Approaches to Establishing Bioequivalence
Requirements for submitting bioavailability (BA) and bioequivalence (BE) data in investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements; the definitions of BA and BE; and the types of in vitro...
Auditoria a Dossiers de AIM: ” Abrangente , esclarecedora e dinámica. Promoveu muito a partilha de experiências entre os colegas”
Teve lugar os dias 28 e 29 de novembro a 3ª edição da formação exclusiva da Formiventos sobre a gestão da Auditoria a Dossiers de AIM , conducida por Selmo Pinto, MRP/DCP Process Manager da INFARMED A formação teve como objetivo a revisão e actualização contínua...
10º ANIVERSÁRIO FORMIVENTOS !
Em dezembro, celebramos mais um Aniversário e assim somamos 10 Anos de existência! Juntamos mais 1 ano de histórias, experiências e aprendizagens. A Formiventos é uma pequena familia de profissionais dedicados e comprometidos com a qualidade e a inovação....
FDA NEWS : Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
Today, the FDA issued the final guidance: Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. FDA is issuing this guidance to clarify our approach for...
New Updated information pack for candidate EU reference laboratories published
The European Commission has just published an Information pack for candidate laboratories in the context of European Union reference laboratories (EURLs) in the field of in vitro diagnostic medical devices. This is a very important document for the reference...
Formação GDP Nível Avançado : “Muito esclarecedor, construtivo, dinâmico, sem dúvidas uma mais-valia
Nos dias 23 e 24 de novembro , realizou-se uma nova edição da formação exclusiva da Formiventos GDP Nível 2 : BOAS PRÁTICAS DE DISTRIBUIÇÃO Nível Avançado, com o objetivo de oferecer uma sessão avançada de alto valor acrescentado, profissionais com experiência...
Clinical Trials Information System (CTIS) – Sponsor Handbook
A compilation of key guidance, technical information, recommendations and references for getting ready for the use of CTIS Executive summary The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors representing pharmaceutical...
Artificial intelligence in European medicines regulation
Published by Artificial intelligence tools are increasingly being applied in the development and use of medicines. Here, we provide a regulatory perspective on such applications. The ability of artificial intelligence (AI) tools to generate new insights and...
Relatório de atividades do Sistema Nacional de Farmacovigilância (SNF) correspondente correspondente ao ano de 2021.
Publicado no site infarmed Já está disponível o relatório de atividades do Sistema Nacional de Farmacovigilância (SNF) correspondente correspondente ao ano de 2021. Até ao final de 2021, o Portal RAM registou cerca de 117.412 notificações de suspeitas Reações...
MASTER COURSE SUPLEMENTOS ALIMENTARES: Mais uma edição marcada pelo sucesso
“A Dra Helena é uma formadora com um vasto conhecimento que disponibiliza a todos os participantes com muita dedicação e sabedoria. Muito obrigado. “. NUTRICATAL Decorreu no passado dia 24 de novembro , a 8ª edição do MASTER COURSE Autorização,...
7ª edição PROMOTIONAL REVIEW COMPLIANCE & BEST PRACTICES: “Formação muito relevante e completa”
No dia 22 de novembro , decorreu mais uma edição da formação exclusiva da Formiventos sobre PROMOTIONAL REVIEW COMPLIANCE & BEST PRACTICES, conduzida pela reconhecida especialista Dra Raquel Miguéis, Regulatory Affairs Senior Officer, da OWL PHARMA CONSULTING...
Key performance indicators (KPIs) to monitor the European clinical trials environment
Key performance indicators (KPIs) to monitor the European clinical trials environment Metrics on the Clinical Trials Regulation and Clinical Trials Directive On the 31 January 2022 the Clinical Trials Regulation (EU) No 536/2014, hereinafter ‘CTR’, repealing...
NEW FDA PRESENTATION: How is My Medical Device Classified
To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device. There are two methods for accomplishing this: go directly to the classification...
Formação sobre as BOAS PRÁTICAS de FARMACOVIGILÂNCIA: ” Muito completa, bem organizada e com um excelente formador “
Teve lugar os dias 16 e 17 de novembro a 7ª edição da formação sobre as 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, inspeções, etc.....
Formação PESSOA RESPONSÁVEL de DISPOSITIVOS MÉDICOS: “Uma Excelente ferramenta de trabalho”
No dia 16 de novembro teve lugar em Lisboa a 3ª edição da formação PESSOA RESPONSÁVEL de DISPOSITIVOS MÉDICOS, bajo o lema " Uma revisão completa e exaustiva dos pontos críticos para garantir o cumprimento permanente dos requisitos e obrigações MDR durante o ciclo...
Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems
This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP) guide. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to the participating...
Contribution of Real-World Evidence in European Medicines Agency’s Regulatory Decision Making
Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been recognized for safety monitoring and disease epidemiology across medicines' life cycles, using RWD/RWE...
A Formiventos é uma das Top 5% melhores PME de Portugal
É com grande satisfação que anunciamos que a Formiventos é uma empresa certificada TOP 5% MELHORES PME PORTUGAL, edição de 2022, certificação atribuída pela SCORING, em termos de desempenho e solidez financeira. Este feito é motivo de orgulho para toda a equipa e...
Boas Praticas de Fabrico da Canabis Medicinal: ” Uma ótima formação, muito interessante e valida para a prática do dia-a-dia”
Nos dias 9 e 10 de novembro teve lugar a 6ª edição da formação GMP para Canábis para fins medicinais, conduzida por André Luz, da Owlpharma Uma formação que ofereceu um enquadramento global muito completo , e que aborda todos os pontos chave a aplicar na...
An Introduction to FDA’s Regulation of Medical Devices
FDA NEW PRESENTATION: An Introduction to FDA’s Regulation of Medical Devices. Explain FDA’s role in regulating medical devices: • Define a medical device and review basics about device classification • Describe five steps to get a new product to market •...
Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
FDA is issuing this guidance to clarify our approach for referencing the terms “device” and “counterfeit device” in FDA documents. For many years, the definition of “device” has been codified at section 201(h) of the Federal Food, Drug, and Cosmetic Act...
Regulatory Affairs da Canábis Medicinal : “Formação abrangente de todos os temas que tocam a regulamentação da Canábis Medicinal , de uma forma sucinta e clara
No dia 28 de outubro teve lugar a 3 ª ediçaõ da formação sobre Regulatory Affairs da Canábis Medicinal, , uma formação exclusiva para a análise dos requisitos para a instrução dos pedidos e procedimentos relativos à concessão de autorizações para o exercício das...
MDCG 2019-6 Rev.4 – Questions and answers: Requirements relating to notified bodies (October 2022)
This document presents questions and answers on requirements relating to notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The issues covered by this document have...
MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
This guidance document is written for authorised representatives, manufacturers and other economic operators, and intends to provide guidance on relevant requirements under the Regulations. Where clarification is already covered by other MDCG guidances, this guidance...
Notified Bodies Survey on certifications and applications(MDR/IVDR) MDCG & Stakeholders 24 Oct 2022
EU MDR/IVDR News! (certifications and applications) Notified Bodies Survey on certifications and applications(MDR/IVDR) MDCG & Stakeholders 24 Oct 2022 General data of Notified bodies replies received – October 2022 Slides 6 & 7 describes well the state...
Formação sobre AUDITORIA DE QUALIDADE : “Muito positiva, com abordagem nos topics todos necessários para a elaboração de uma auditoria interna”
Decorreu a 1ª edição da formação AUDITORIA INTERNA da QUALIDADE , bajo o lema Boas Práticas no Planeamento, realização e relatórios; classificação e follow-up das não conformidades, e avaliação da eficácia das CAPAS, conduzida pela especialista Dra. Marta Monteiro...
ICH releases M11 guideline proposing harmonized template for trial protocols
The International Council for Harmonisation (ICH) has released a draft guideline which outlines a harmonized template for clinical trial protocols to support consistent reporting among sponsors. The draft guideline, as well as the template and specifications for the...
MDR/IVDR IMPLEMENTATION ROLLING PLAN: Latest update: October 2022
MDR/IVDR IMPLEMENTATION ROLLING PLAN: Latest update: October 2022 Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This rolling plan contains a list of identified essential implementing acts and other relevant initiatives that the Commission has adopted...
FDA Advancing Real-World Evidence Program
As announced in the Federal Register notice published on October 20, 2022, FDA is conducting an Advancing Real-World Evidence (RWE) Program, which seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims,...
UK Regulation News : New Regulations Implementation deadline – Medical Devices – IVDs
Future regulation of medical devices – extension of standstill period "We are therefore putting in place a twelve-month extension to the current standstill period, aiming to bring the new regulations into force in July 2024. This will provide additional time to...
Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources
The Good Practice Guide aims to provide recommendations for the use of the EU metadata catalogue to identify real-world data sources suitable for specific research questions and to assess the suitability of data sources proposed to be used in a study...
High-quality data to empower data-driven medicines regulation in the European Union
PUBLISHED BY EMA News 10/10/2022 EMA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the quality of the data that underpin decision-making on the benefits and risks of...
Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
Evaluation of premarket approval applications (PMA) by the Food and Drug Administration (FDA) is a multi-step process in which we evaluate whether reasonable assurance of device safety and effectiveness has been demonstrated. To provide reasonable assurance, or the...