NOTICIAS

Boas Práticas de Fabrico : Uma formação foi muito interessante

Boas Práticas de Fabrico : Uma formação foi muito interessante

Teve lugar no dia 24 de novembro a 3ª edição da formação sobre as BOAS PRÁTICAS DE FABRICO,conduzida pelo especialista Dr André Luz, da OWLPHARMA  Nesta formação forneceu um análise detalhada  das novas regulamentações , e foram abordados assuntos como : Novos...

Proposal on European data governance

Proposal on European data governance

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on European data governance (Data Governance Act)   This explanatory memorandum accompanies the proposal for a Regulation of the European Parliament and of the Council on data governance. It is the first of...

EUDAMED ACTOR MODULE FAQs

EUDAMED ACTOR MODULE FAQs

ACTOR MODULE FAQs November 2020 v1.0 Table of Contents 1. Countries available in EUDAMED from December 2020 2. Actor registration process 3. SRN 4. Actor roles 5. EUDAMED users 6. Support 7. Data Exchange

Contract Manufacturing Databook

Contract Manufacturing Databook

SOURCE : INDUSTRY STANDAR RESEARCH . ISR Reports . www.isrreports.com It can be difficult to find industry-specific, easy-to-interpret, trustworthy market data. This e-book is full of free drug development and manufacturing facts, figures, and expert perspectives...

ANATOMY OF A FAILURE TO LAUNCH

ANATOMY OF A FAILURE TO LAUNCH

ANATOMY OF A FAILURE TO LAUNCH: A REVIEW OF BARRIERS TO GENERIC AND BIOSIMILAR MARKET ENTRY AND THE USE OF COMPETITION LAW AS A REMEDY   The purpose of this whitepaper is to examine the evolution of specific barriers to generic and biosimilar market entry in the...

Ongoing guidance development within MDCG Subgroups

Ongoing guidance development within MDCG Subgroups

NEWS FROM EU: Ongoing guidance development within MDCG Subgroups – October 2020*. A lot of guidances planned in 2021!!!   Ongoing guidance development within MDCG Subgroups        

Novo Sistema de Informação para Dispositivos Médicos (SIDM)

Novo Sistema de Informação para Dispositivos Médicos (SIDM)

Publicado no site Infarmed ,19 out 2020 Circular Informativa N.º 164/CD/100.20.200 Data: 19/10/2020 Com o objetivo de garantir que os dispositivos médicos (DM) existentes no mercado nacional respeitam os requisitos regulamentares de qualidade, segurança e desempenho,...

Guide to Using EUDAMED

Guide to Using EUDAMED

Guide to Using EUDAMED Actor registration module for economic operators Version 0.1 – September 2020   EUDAMED is the IT system developed by the European Commission to implement the EU medical devices regulations: Regulation 2017/745 on medical devices...

EMA offers new Q&A on data monitoring committees

EMA offers new Q&A on data monitoring committees

Published EMA  : Posted 08 October 2020 | By Michael Mezher  The European Medicines Agency (EMA) on Thursday released a new guideline offering nine questions and answers on issues related to the role of data monitoring committees (DMCs) in the conduct and management...

EMA moves to IRIS for scientific advice questions

EMA moves to IRIS for scientific advice questions

Posted 07 October 2020 | By Kari Oakes  The European Medicines Agency (EMA) is transitioning to an online platform for drug developers to use when requesting scientific advice. The change will become effective on 19 October for developers of both human and veterinary...

EMA  Guideline : Quality of water for pharmaceutical use

EMA Guideline : Quality of water for pharmaceutical use

The guideline has been updated to reflect changes in the European Pharmacopoeia including the revised monograph for Water for Injections allowing methods other than distillation for producing water of injectable quality. The guideline has also been updated to reflect...

Novas creditações para as próximas formações de Outubro e Novembro

Novas creditações para as próximas formações de Outubro e Novembro

As seguintes formações contam com a  acreditação pela Ordem dos Farmacêuticos   Boas Práticas de Distribuição de Medicamentos. 14ª Edição 2 e 3 de dezembro de 2020 1.4 CDP ( 00207/9/2020 ) Boas Práticas de Distribuição de Medicamentos.13ª Edição 24 e 25 de...

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...