NOTICIAS
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. FDA Guidance for Industry
This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. Cannabis and cannabis-derived compounds that may be used in drug manufacturing...
Veterinary Medicines Regulation HIGHLIGHTS
The European Union create the newsletter for the Implementation of the Veterinary Medicines Regulation (VMP-Reg) Programme. The Regulation will become applicable in January 2022 after a 3-year implementation period. In 2019, EMA focussed on preparing a number of...
Clinical evaluation assessment report template .July 2020
This template applies to MDR Annexes IX section 4 and Annex X section 3. It also applies to assessments of technical documentations on a sampling basis for class IIa/IIb devices in accordance with Annex IX sections 2.3 and 3.5 and Section 10 of Annex XI(A). Aspects...
BOAS PRÁTICAS de DISTRIBUIÇÃO de MEDICAMENTOS: “Muito útil, dado por alguém com muito conhecimento.Temas muito bem estruturados”
Reconheciendo a relevância do cumprimento das Boas Práticas de Distribuição na indústria farmacêutica, a Formiventos organizou a edição número 12 do Curso : BOAS PRÁTICAS de DISTRIBUIÇÃO de medicamentos de uso humano e de substâncias ativas Nesta nova edição foram...
Vagas esgotadas para a formação sobre PROMOTIONAL REVIEW
No próximo 21 de Julho , terá lugar a 3ª edição da formação exclusiva da Formiventos sobre PROMOTIONAL REVIEW COMPLIANCE & BEST PRACTICES conduzida pelo especialista DR Ricardo Andrade, Managing Director , da OWL PHARMA CONSULTING, bajo o lema “Como conseguir a...
The Value and Pricing of Innovative Medicines. @eupatientsforum
The European Patients Forum has released a new position paper entitled ‘The Value and Pricing of Innovative Medicines' . EPF’s position is based on the premise that health is a fundamental right and a critical investment in the well-being, economic development and...
ÚLTIMAS VAGAS na formação Boas Práticas de Distribuição de Medicamentos
A 13ª edição da formação sobre as BOAS PRÁTICAS de DISTRIBUIÇÃO de medicamentos de uso humano e de substâncias ativas, terá lugar os 14 e 15 de julho Para garantir condições ótimas de segurança, eficácia e conforto, o número de participantes é limitado HOT TOPICS...
Estratégia da Rede de Agências Europeias de Medicamentos até 2025 em consulta pública
publicado no site INFARMED 07 jul 2020 Os Chefes das Agências de Medicamentos (HMA na sigla inglesa) e a Agência Europeia de Medicamentos (EMA na sigla inglesa) lançaram uma consulta pública sobre a Estratégia da Rede de Agências Europeias de Medicamentos até...
Signal management: EMA e-learning course
These training materials seek to further improve understanding of signal management within the European medicines regulatory network and develop best practice in signal management. The course gives an overview of best practice in signal management. Main topics...
International regulators provide guiding principles for COVID-19 clinical trials
EMA Press release 01/07/2020. published by EMA ema.europa.eu EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). Medicines regulators from around the...
Review and Update of Device Establishment Inspection Processes and Standards
FDA believes that uniformity in investigators’ approaches to inspections, both before and during, may inform firms’ preparation for the inspection and set baseline communication and timing expectations for each party. The processes and standards identified below...
APORMED publica Orientações para a retoma da interação entre os profissionais da indústria e os profissionais de saúde
Dada a elevada importância dos dispositivos médicos para os cuidados de saúde dos cidadãos portugueses e dos utentes do Sistema Nacional de Saude e por forma a garantir que os dispositivos médico são devidamente utilizados, é imprescindível a interação dos técnicos...
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....