NOTICIAS

EMA  Guideline on registry-based studies

EMA Guideline on registry-based studies

published by EMA News 24/09/2020. EMA has published its draft  Guideline on registry-based studies for a three-month public consultation today. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence. Patient...

FDA NEW GUIDANCE : “Biological evaluation of medical devices

FDA NEW GUIDANCE : “Biological evaluation of medical devices

The scope of this document and accompanying attachments is limited to the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact  with the human body. This document specifically covers the use of ISO 10993-1 but also...

NEW MDSAP DOCUMENT: mdsap audit approach.

NEW MDSAP DOCUMENT: mdsap audit approach.

The intention of the Medical Device Single Audit Program (MDSAP) is to allow competent auditors from MDSAP recognized Auditing Organizations (AOs) to conduct a single audit of a medical device organization’s quality management system that will satisfy the requirements...

COSMETIC BORDELINE MANUAL. SEPT 2020

COSMETIC BORDELINE MANUAL. SEPT 2020

MANUAL OF THE WORKING GROUP ON COSMETIC PRODUCTS (SUB-GROUP ON BORDERLINE PRODUCTS) ON THE SCOPE OF APPLICATION OF THE COSMETICS REGULATION (EC) NO 1223/2009 (ART. 2(1)(A)) VERSION 5.2 (SEPTEMBER 2020)   The clear determination of the scope of application of...

CONTRATAÇÃO PÚBLICA – GUIA PRÁTICO PARA PROFISSIONAIS

CONTRATAÇÃO PÚBLICA – GUIA PRÁTICO PARA PROFISSIONAIS

O presente guia destina-se essencialmente aos profissionais que, lidando com contratos públicos no seio de autoridades adjudicantes na União Europeia, são responsáveis por planear e levar a cabo uma aquisição conforme, eficiente e com uma boa relação qualidade/preço...

EMA new guideline on the Quality of Water for Pharmaceutical Use

EMA new guideline on the Quality of Water for Pharmaceutical Use

  The European Medicines Agency  issued a new guideline on the quality of water for pharmaceutical use that will replace its nearly two-decades-old guidance and position statement on water quality when it takes effect in February 2021   This document is...

Launch of public consultation on joint network strategy to 2025

Launch of public consultation on joint network strategy to 2025

EMA and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that is released for a two-month public consultation today. The draft strategy details how the European medicines agencies’ network can continue to enable the supply...

FDA New Guidance on Multiple Function Device Products

FDA New Guidance on Multiple Function Device Products

Medical products may contain several functions, some of which are subject to FDA’s regulatory oversight as medical devices, while others are not. Section 3060(a) of the 21st Century CuresAct (Cures Act) amended the Federal Food Drug, and Cosmetic Act (FD&C Act) to...

Veterinary Medicines Regulation HIGHLIGHTS

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

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...

Vagas esgotadas para a formação sobre PROMOTIONAL REVIEW

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 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...

Signal management: EMA e-learning course

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...

NOVAS REGRAS DE SEGURANÇA

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

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)

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

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   

O sector não pára e nós também não!

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?

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 preparing big data Q&A guidance

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...

Trade in Counterfeit Pharmaceutical Products

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

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...