NOTICIAS
Medicines for Europe “LESSONS LEARNED FROM COVID-19”
After several months of crisis, we can discern some of the key lessons learned from COVID-19 for the future of pharmaceutical policy in Europe. Lessons learned from Covid-19 – Policy Paper
NOVAS REGRAS DE SEGURANÇA
Garantimos formações em condições ótimas de segurança, eficácia e conforto, com número de participantes limitado O número de presentes será muito reduzido – Máximo de 10 pessoas na sala A sala tem mais do dobro do espaço habitual, e cada participante terá um...
Estratégia Farmacêutica Europeia em consulta pública
Publicado no site Infarmed 8 jun 2020 A Comissão Europeia lançou a 16 de junho de 2020 uma consulta pública on-line sobre a estratégia europeia para o setor farmacêutico. Esta estratégia procura garantir o fornecimento de medicamentos seguros e acessíveis na Europa...
New Guidance on Good Clinical Practice (GCP)
In the context of this guidance, a remote / distant GCP inspection is defined as “the process of conducting inspections at a distance / virtually, supported by technology for communicating, sharing, reviewing, and developing documents and accessing systems, without...
Novas formações 2020
Apresentamos-lhe as novas formações para 2020 que esperamos sejam do seu interesse Formações em condições ótimas de segurança, eficácia e conforto, com número de participantes limitado
In-company BOAS PRÁTICAS DE DISTRIBUIÇÃO: Soluções à medida da sua empresa
De acordo com as GDP, o Diretor Técnico tem a responsabilidade de garantir os programas de formação inicial e contínua do pessoal no que respeita ao cumprimento das BOAS PRÁTICAS A regulamentação especifica a necessidade da formação do pessoal relativamente a: .-...
12ª Edição a formação BOAS PRÁTICAS de DISTRIBUIÇÃO, 14 e 15 de julho
Nos próximos dias 14 e 15 de julho de 2020 terá lugar a 12ª Edição da formação BOAS PRÁTICAS de DISTRIBUIÇÃO de medicamentos de uso humano e de substâncias ativas, conduzida pela reconhecida especialista Dra Sónia Rei, Head of Quality Systems & QP,...
Prospective dialogue between developers and regulators makes for better evidence generation
News 27/05/2020 EMA, in collaboration with other parties, has recently published two scientific articles outlining the importance of early interactions as an opportunity to improve the generation of evidence required for bringing innovation to patients. An article,...
O sector não pára e nós também não!
Estamos de volta ao trabalho após o encerramento causado pela pandemia COVID-19 Estamos a trabalhar para lhe voltar a oferecer as nossas iniciativas de formação, em condições otimas de segurança, eficácia e conforto. Nos próximos dias apresentaremos as datas do...
What is the state of play of the implementation of EUDAMED?
Currently, the EC database on medical devices, Eudamed2, is a secure web-based portal. It is a central repository for information on market surveillance exchanged between national competent authorities and the Commission. Its use is restricted to national competent...
EMA calls for high-quality observational research in context of COVID-19
26 May 2020 EMA/269353/2020 Media and Public Relations For observational studies of real world data in COVID-19, EMA calls for transparency for protocols and results, and collaboration between researchers, to ensure high-quality, powerful studies. High-quality...
Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form
Main changes introduced by the new MIR form The European Competent Authorities and Industry representative organisations agreed to use codified information on incidents (adverse events in IMDRF terminology) for the reporting of incidents in advance of the date...
EUROPEAN COMMISSION Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
Safety reporting in clinical investigations of medical devices shall be performed in line with the requirements of the Regulation (EU) 2017/745 – Medical Device Regulation (MDR) Article 80(2): The sponsor shall report, without delay to all Member States in...
EMA preparing big data Q&A guidance
EMA is preparing a question-and-answer guidance document on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines. The aim is to help medicine developers, data providers...
Medidas excecionais no âmbito da realização de Ensaios Clínicos durante o período de risco para a saúde pública – versão 3
INFARMED 11 mai 2020 Na sequência de emergência de Saúde Pública de âmbito Internacional declarada pela Organização Mundial de Saúde em 30/01/2020 para infeção por SARS-CoV-2 (novo coronavírus 2019), no que se refere à realização de ensaios clínicos em Portugal, o...
Launch of enhanced monitoring system for availability of medicines used for treating COVID-19
EMA, together with the pharmaceutical industry and the EU Member States, has launched its enhanced fast-track monitoring system to help prevent and mitigate supply issues with crucial medicines used for treating patients with COVID-19. Under this system, each...
Trade in Counterfeit Pharmaceutical Products
This report, one in a series of studies by the OECD and the European Union Intellectual Property Office (EUIPO), is designed to enhance understanding of the issues and challenges facing governments, businesses and society posed by the trade in fake pharmaceutical...
Cambridge University :The Future of Medicine
Nanobots that patrol our bodies, killer immune cells hunting and destroying cancer cells, biological scissors that cut out defective genes: these are just some of the technologies that Cambridge University researchers are developing and which are set to revolutionise...
Regulatory flexibility to ensure availability of veterinary medicines during COVID-19 pandemic
The European Commission, EMA and the Coordination Group for Mutual Recognition and Decentralised Procedure – Veterinary (CMDv) have issued guidance on adaptations to the regulatory framework to companies that develop, manufacture and distribute veterinary medicines in...
Union procedure on the follow-up of pharmacovigilance inspections
Date for coming into effect 01 May 2020 This procedure defines the steps in the follow-up of pharmacovigilance inspections and the responsibilities of the parties involved. This includes the process for requesting a CAPA plan in writing from the MAH, CAPA plan review...
New Guidances from European Commission’s Medical Device Coordination Group
The European Commission’s Medical Device Coordination Group (MDCG) on Friday posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for postmarket clinical follow-up plans and evaluation reports; and...
Personalized Medical Devices – Regulatory Pathways
The purpose of this IMDRF guidance is to recommend a harmonized approach for the application of existing regulatory pathways to medical devices that are intended for a particular individual, and to identify special considerations for the regulation of each identified...
Nova data regulamentação MDR: 26 maio 2021
O Regulamento dos Dispositivos Médicos 2017/745 (MDR), entrará oficialmente em vigor em 2021, o dia 26 de maio. NEWS FROM EP: The European Parliament has approved the amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain...
News from Medical Device Coordination Group Document: New Documents& Templates
NEWS FROM MDCG: four new documents: MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies : This MDCG guidance covers the demonstration of equivalence, based on data pertaining to an already existing device on the market ,...
Final Guidance on Principles and Practices for Medical Device Cybersecurity
This document is designed to provide concrete recommendations to all responsible stakeholders on the general principles and best practices for medical device cybersecurity (including in vitro diagnostic (IVD) medical devices). It outlines recommendations for...
Flexibilidade regulamentar durante a pandemia COVID-19: guia operacional emitido pelo Grupo de Coordenação, CMDh
April 2020 .CMDh/418/2020 Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis This document is prepared by CMDh in line with and in addition to the EC/EMA/HMA “Notice to stakeholders: Questions and answers on regulatory...
Fabrico, importação, colocação e disponibilização no mercado nacional de dispositivos médicos (DM) para efeitos de prevenção do contágio do novo coronavírus
INFARMED 21 abr 2020 Com a publicação do Decreto-Lei n.º 14-E/2020, de 13 de abril, que estabelece um regime excecional e transitório relativo ao fabrico, importação, colocação e disponibilização no mercado nacional de dispositivos médicos (DM) e de...
Update to guidance on regulatory expectations in the context of COVID-19 pandemic
EMA News 20/04/2020 The European Commission, EMA and the national competent authorities have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant...
MDR postponed to may 2021
NEWS FROM EP: The European Parliament has approved the amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions. MDR postponed to may 2021. Parliament decides to postpone new requirements for medical...
Regime excecional e temporário para a conceção, o fabrico, a importação, a comercialização nacional e a utilização de Dispositivos Médicos
Decreto-Lei n.º 14-E/2020 Publicação: Diário da República n.º 72/2020, 2º Suplemento, Série I de 2020-04-13 Emissor:Presidência do Conselho de Ministros Entidade Proponente:Economia e Transição Digital Tipo de Diploma:Decreto-Lei Número:14-E/2020 Páginas:86-(2)...
Adaptação de procedimentos regulamentares para resposta aos desafios colocados pela pandemia
Publicado pelo Infarmed Circular Informativa N.º 186/CD/100.20.200 Data:14/04/2020 A Comissão Europeia, a Agência Europeia do medicamento (EMA na sigla inglesa) e a rede europeia de autoridades competentes em medicamentos, da qual o Infarmed faz parte, prepararam um...
Guidance on regulatory requirements in the context of the COVID-19 pandemic
EMA News 10/04/2020 The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from...
EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines
Press release 09/04/2020 As part of its health threat plan activated to fight COVID-19, the Agency has finalised and published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF), which assists Member States and the European Commission...
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
This guidance is intended to cover the following audits notified bodies are requested to carry out as part of medical devices conformity assessments: surveillance audits under the medical devices Directives, audits conducted for re-certification purposes under...
IMDRF new Consultations Focus on IVD Classifications, Regulatory Assessors
The International Medical Device Regulators Forum released two consultations for comment on classifying in vitro diagnostics (IVDs) and improving the efficiency and ensuring regulators appropriately conduct assessments of Conformity Assessment Bodies ...
European Commission Proposes to Delay MDR by a Year Due to COVID-19
Amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions Reasons for and objectives of the proposal Regulation (EU) 2017/745 of the European Parliament and of the Council, adopted on 5 April 2017,...
#The200Challenge: Respecting Social distancing but staying closer than ever.
Na Formiventos ficamos activos para os nossos clientes. Reestruturamos a nossa forma de trabalho e continuamos juntos ,mas separados Alguma questão, estamos deste lado Respecting Social distancing but staying closer than ever
Advancing regulatory science in the EU – new strategy adopted
Press release 31/03/2020 EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic...
Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
Version 2 (27/03/2020) EMA, the European Commission and the Heads of Medicines Agencies updated the Guidance on the management of clinical trials during #COVID19 to cover safety reporting, the distribution of in-vitro diagnostics, medical devices and auditing....
Medidas excecionais no âmbito da realização de Ensaios Clínicos durante o período de risco para a saúde pública (COVID-19)
Infarmed publica novas medidas no âmbito da realização de Ensaios Clínicos Na sequência de emergência de Saúde Pública de âmbito Internacional, declarada pela Organização Mundial de Saúde em 30/01/2020 para a infeção por SARS-CoV-2 (novo coronavírus 2019), e no...
EU GMP Annex 21 finally published
On 20 March, after some delays, the new Annex 21 to the EU-GMP Guidelines was published as a draft This Annex summarizes the GMP requirements applicable to a Manufacturing Import Authorisation (MIA) holder which imports medicinal products (human and veterinary) from...
NEWS FROM EU: legislative proposal to pospone the MDR application date by 1 year
The European Commission has just confirmed that, due to the current health emergency, in early April it will present a legislative proposal to pospone the MDR application date by 1 year (May 26, 2021) https://europa.eu/!My48pY ...
MDCG 2020-3. 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
This guidance document is intended to provide clarification on the changes to a device that should be considered a “significant change in design or a significant change in the intended purpose” under MDR Article 120(3). Assessments should be made on a case-by-case...
DISPOSITIVOS MÉDICOS 2020 .1ª edição : “De extrema utilidade para quem trabalha com DM´S “
Teve lugar no passado dia 10 de março a 1ª edição da formação DISPOSITIVOS MÉDICOS 2020 : Uma visão abrangente dos requisitos, exigências e implicações do novo regulamento: “Abordagem muito útil do novo regulamento dos Dispositivos Médicos. De extrema utilidade para...
Boas Práticas de Distribuição de Medicamentos: 22 e 23 de abril de 2020
No próximo mes de abril vai decorrer a edição 12 da formação BOAS PRÁTICAS de DISTRIBUIÇÃO de medicamentos de uso humano e de substâncias ativas;uma formação interativa que inclui excelentes exercícios práticos , e uma analise em detalhe de todos os...
Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation
This document is provided by the Commission services for information purposes only. It does not contain any authoritative interpretation of EU law, in particular EU acts referred to in it, and it does not constitute a decision or position of the Commission. It is...
Nova creditação da Ordem dos Farmacêuticos para a 1ª Edição da formação sobre DISPOSITIVOS MÉDICOS
No próximo 10 de março vai decorrer no hotel Novotel de lisboa a primeira edição da formação DISPOSITIVOS MÉDICOS 2020:Uma visão abrangente dos requisitos, exigências e implicações do novo regulamento. A Phagecon em parceria com a Formiventos organizou esta formação...
Formação CTD MODULO 3: Formação de excelente qualidade !
No passado dia 4 de março teve lugar a 2ª edição da formação sobre o CTD MODULO 3, conduzida pelo reconhecido especialista Dr Pedro Fins Pereira, Gestor de PRM e PDC / MRP/DCP Procedure Manager, da Direção de Avaliação de Medicamentos/Unidade de Manutenção no...
Formação sobre “Novos pedidos de AIM”, acreditada pela Ordem dos Farmacêuticos
A formação sobre os Novos pedidos de AIM que decorrerá nos próximos dias 16 e 17 de abril de , bajo o lema " Uma combinação de teoria e exercícios práticos, para adquirir os conhecimentos cruciais para gerir com sucesso a tramitação completa do seus Novos...
Explanatory Note to GVP Module VII
The following explanatory note to Good Pharmacovigilance Practices (GVP) Module VII aims at addressing the challenges encountered during the two years of running the PSUSA process. Ultimately, the explanatory note will serve as the basis for the update of GVP Module...
EMA Implementation of ICH Q12 Guideline
ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management Globalisation of the supply chain and market for medicinal products has resulted in a growing number of different procedures, rules and regulations which MA Holders...