NOTICIAS

CLINICAL TRIALS REGULATION:(EU) Nr. 536/2014.

CLINICAL TRIALS REGULATION:(EU) Nr. 536/2014.

CLINICAL TRIALS REGULATION:(EU) Nr. 536/2014. Clinical trials on medicinal products for human use. DRAFT QUESTIONS & ANSWERS VERSION 3 Submitted for discussion to the Expert Group on Clinical Trials. febuary 2021.   The new Clinical Trials legislation has...

EMA has published the EU IDMP Implementation Guide version 2.0

EMA has published the EU IDMP Implementation Guide version 2.0

EMA has published the EU IDMP Implementation Guide version 2.0. This version provides the basis for medicinal product data exchange in the EU and focuses on supporting the European medicines regulatory network to prepare for the implementation of the Product...

EUDAMED NEWS: management of legacy devices.

EUDAMED NEWS: management of legacy devices.

EUDAMED NEWS: management of legacy devices. Date: 08.02.2021 This document contains the details of how Legacy Devices will be identified in EUDAMED and the way the different Unique Device Identifiers for the Legacy Devices will be generated/assigned.    ...

GVP: EMA  revised risk minimization module

GVP: EMA revised risk minimization module

Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with revision 3 of Module XVI on risk minimisation measures and its Addendum II on methods for their effectiveness evaluation for public consultation     A pubnlic...

Veterinary Medicinal Products Regulation HIGHLIGHTS

Veterinary Medicinal Products Regulation HIGHLIGHTS

News, views and interviews for the Veterinary Medicinal Products Regulation.Published every two months by the European Medicines Agency   EMA has published the third issue of the Veterinary Medicines Regulation highlights newsletter. In 2020, the programme...

CREDITAÇÃO DA OF PARA A FORMAÇÃO ” CTD MODULO 3 “

CREDITAÇÃO DA OF PARA A FORMAÇÃO ” CTD MODULO 3 “

A 2 ª Edição do Workshop Prático sobre   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 Mercado  do Infarmed, foi...

FORMAÇÕES 2021 : CREDITAÇÕES PELA ORDEM DOS FARMACÊUTICOS.

FORMAÇÕES 2021 : CREDITAÇÕES PELA ORDEM DOS FARMACÊUTICOS.

Novas creditações para as próximas formações de Outubro e Novembro As seguintes formações contam com a  acreditação pela Ordem dos Farmacêuticos   Gestão de Alterações aos termos de AIM 9 e 10 de março de 2021 1.4 CDP ( 00007/01/2021 ) Boas Práticas de...

Calendário de formações 2021

Calendário de formações 2021

Através da investigação contínua com os nossos clientes, e os nossos oradores, e mediante a pesquisa na comunidade empresarial, criamos conteúdos de alto valor acrescentado, inovadores e exclusivos  com o único propósito de desenvolver as qualificações, competências e...

Register medical devices to place on the market

Register medical devices to place on the market

How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland The following devices in Great Britain (England, Wales and Scotland) need to be registered with...

Register as a manufacturer to sell medical devices from 1 January 2021

Register as a manufacturer to sell medical devices from 1 January 2021

  Published 7 December 2020 Last updated 7 December 2020 — see all updates From: Medicines and Healthcare products Regulatory Agency How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great...

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...