NOTICIAS

No dia 2 de fevereiro, decorreu mais uma edição da formação exclusiva da Formiventos sobre ENSAIOS CLÍNICOS 2023 :Uma revisão completa da regulamentação aplicável à investigação clínica com Medicamentos e Dispositivos Médicos Uma Sessão avançada de aprofundamento para...

Publicado no site INFARMED 01 fev 2023   Foi publicado, no dia 30 de janeiro, um guia rápido dirigido a Promotores de ensaios clínicos. Este guia reúne os principais aspetos, regras e procedimentos a seguir pelos Promotores que pretendem submeter e realizar...

This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of human drugs containing cannabis or cannabis-derived compounds. As defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act...

The new ”NIS2” entered into force earlier this month with the aim to improve cybersecurity across sectors in the EU, in which medical device and IVD manufacturers are listed as a critical sector (Annex II, §5b).   DIRECTIVE (EU) 2022/2555 OF THE EUROPEAN...

  The EU Directives and the EU Guide to GMP define some detailed requirements to be met by the Qualified Person (QP). These requirements have been extracted from the relevant documents and are summarized in the Good Practice Guide "Code of Practice for QPs"....

The pandemic that changed everything The COVID-19 pandemic permanently changed global health care - from accelerating the adoption of new technology and care delivery models to increasing the focus on sustainability and resiliency.   COVID-19 has had a profound...

  The Medical Device Coordination Group (MDCG) has published the guidance MDCG 2023-1 which aims to support a harmonised application of Article 5(5) of Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). This document is written for healthcare professionals...

Published by EMA News 31/10/2013 Amendments of the European Union (EU) pharmacovigilance legislation that were adopted in October 2012 came into force on Monday 28 October 2013. These changes, which cover various aspects of the legislation, aim to further strengthen...

   INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE QUALITY RISK MANAGEMENT Q9(R1) Final version Adopted on 18 January 2023   The ICH Q9(R1) Guideline reached Step 4 of the ICH...

O RA tem de ser um sócio estratégico nas organizações, como peça chave nas equipas de trabalho trasnversais Nos últimos anos a Indústria Farmacêutica está a experimentar uma forte e intensa transformação; os  novos modelos de negócio,  a transformação digital, a...

Press Release Published by infarmet.pt   Real4Reg – a new European research project on real world data Regulatory and health technology assessment (HTA) agencies, academic institutions and patient organisations from six EU countries will improve the use of...

  Big Data Steering Group (BDSG) 2022 report is now available.   In the document below, check out the key activities and achievements last year, which include:   ✅The appointment and establishment of the DARWIN EU ® coordination centre;  ...

Summary MDR codes coverage  More than 80% of codes are covered by more than 20/36 NBs  Just 5 codes are covered by less than 1/3 NBs: ─ MDA 0102:Active implantable devices delivering drugs or other substances ─ MDA 0104: Active implantable devices utilising...

Unprecedented disruptions caused by the COVID-19 pandemic, followed by social, economic, geopolitical and environmental challenges, continue to place complex and interconnected threats on health and healthcare systems. But the past few years have also allowed for...

The present study surveys the ongoing standardisation activities on AI carried out by ESOs (European Standards Organizations) and international Standards Development Organizations (SDOs). In the present study we investigate the alignment between AI related standards...

Publication date 10 January 2023 Author  Directorate-General for Health and Food Safety   Medical devices can be manufactured and used within EU health institutions (in-house devices), on a non-industrial scale, to address the specific needs of target patient...

  Publication date 9 January 2023 Author    Directorate-General for Health and Food Safety   IMPLEMENTATION ROLLING PLAN 2023-2024 REGULATION (EU) 2021/2282 ON HEALTH TECHNOLOGY ASSESSMENT This rolling plan contains a list of key activities that the...

Today, the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines...

    Reasons for and objectives of the proposal Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) of the European Parliament and of the Council establish a reinforced regulatory framework for medical devices and in vitro diagnostic medical...

This guidance provides recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product. A REMS document, which is part of a REMS that is required by FDA,...

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...

  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...

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 (only for Minimum Viable Product (MVP) Legal Priority) Consolidated version of functional specifications for EUDAMED (version 7.2)  

  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...

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...

  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...

  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...

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...

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...

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...

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...

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...

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...

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...

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 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...

 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...

  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...

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...

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....

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...

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...

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...

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...

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...

 “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,...

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 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...

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...