NOTICIAS

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

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...

Union procedure on the follow-up of pharmacovigilance inspections

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...

Personalized Medical Devices – Regulatory Pathways

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...

MDR postponed to may 2021

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...

European Commission Proposes to Delay MDR by a Year Due to COVID-19

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,...

Advancing regulatory science in the EU – new strategy adopted

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...