NOTICIAS

Artificial intelligence in medicine regulation

Artificial intelligence in medicine regulation

published by EMA News 16/08/2021   The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in...

Clinical Trial Information System (CTIS) – Sponsor Handbook

Clinical Trial Information System (CTIS) – Sponsor Handbook

published by 28 July 2021 EMA/299895/2021 – v. 1.00 Clinical Trials Information System (CTIS) programme   A compilation of key guidance, technical information, recommendations and references for getting ready for use of CTIS   The aim of the EMA CTIS Sponsor...

Sistema europeu de ensaios clínicos lançado em janeiro

Sistema europeu de ensaios clínicos lançado em janeiro

PUBLICADONO SITE INFARMED Infarmed NOTICIAS 02 ago 2021 A Comissão Europeia (CE) confirmou que a entrada em vigor do Regulamento Europeu de Ensaios Clínicos, bem como o lançamento do Sistema Europeu de Ensaios Clínicos (Clinical Trials Information System - CTIS),...

EMA new guidelines on veterinary pharmacovigilance

EMA new guidelines on veterinary pharmacovigilance

PUBLISHED BY EMA. https://www.ema.europa.eu/   The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) contains new legal provisions on veterinary pharmacovigilance. These aim to focus on continuous signal management based on adverse event data in...

Veterinary product information templates

Veterinary product information templates

PUBLISHED BY EMA 16/7/2021EMA has made available a new product information template for #veterinary medicines to support the implementation of the Veterinary Medicinal Products Regulation which enters into application in January 2022: https://lnkd.in/eeecwSh    The...

Formação sobre Regulatory Affairs da Canábis Medicinal

Formação sobre Regulatory Affairs da Canábis Medicinal

Teve lugar a 1ª edição da formação REGULATORY AFFAIRS DA CANÁBIS MEDICINAL , conduzida pela reconhecida especialista Dra Patrícia Proença,Managing Partner na PharConsulting Global Nesta formação os participantes tiveram a  oportunidade de adquirir os...

Medical Device Regulation comes into application

Medical Device Regulation comes into application

Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and...

Clinical investigation application/notification documents

Clinical investigation application/notification documents

The sponsor of a clinical investigation is required to submit an application/notification1 to the Member State(s) in which a clinical investigation is to be conducted, accompanied by the documentation referred to in Chapter II of Annex XV of Regulation (EU) 2017/745...

VAGAS ESGOTADAS para a formação AUDITORIA A DOSSIERS de  AIM

VAGAS ESGOTADAS para a formação AUDITORIA A DOSSIERS de AIM

Irá decorrer nos próximos dias 12 e 13 de maio  a formação : Auditoria a Dossiers de AIM : Boas práticas regulamentares na submissão e Resubmissão de dossiers de AIMs Revisão sistemática do módulo 1 e respetivos  documentos de um dossier de AIM Como monitorizar e...

VAGAS ESGOTADAS para a formação PROMOTIONAL REVIEW

VAGAS ESGOTADAS para a formação PROMOTIONAL REVIEW

  Devido à grande procura, mais uma turma da formação  “PROMOTIONAL REVIEW : COMPLIANCE AND BEST PRACTICES: Como conseguir a máxima qualidade na supervisão e manter a conformidade regulamentar em todos os  materiais promocionais multimedia ,”, encerrou suas...

MDCG 2021-6 Questions & Answers regarding Clinical Investigations

MDCG 2021-6 Questions & Answers regarding Clinical Investigations

This document is intended for sponsors of clinical investigations of medical devices conducted within the scope of the Regulation (EU) 2017/745 (MDR) This guidance covers important topics as: - clinical investigation definitions in the context of EU MDR - general...

MDR/IVDR: Commission adopts new standardization request

MDR/IVDR: Commission adopts new standardization request

NEWS FROM MDCG: MDCG 2021-5 Guidance on standardisation for medical devices The European Commission this week adopted a new standardization request for harmonized European standards in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic...

Updated Rolling Plan MDR/IVDR has been published by the MDCG

Updated Rolling Plan MDR/IVDR has been published by the MDCG

This rolling plan contains the list of essential implementing acts and actions for the transitional period as well as information on expected timelines and state-of-play. Its 2 main sections are implementing acts and other actions/initiatives. The rolling plan will be...

MDCG administrative practices guidance

MDCG administrative practices guidance

The Medical Device Coordination Group (MDCG) has issued a Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. The document provides guidance to Member States and other relevant parties on the...

FDA offers real-world evidence examples in device applications

FDA offers real-world evidence examples in device applications

Selected examples with file summaries, details on real-world data source, populations, and descriptions of use   Real-world data (RWD) can be collected from a diverse array of sources, such as electronic health records, registries, administrative claims, pharmacy...

Lançamento do Projeto-piloto de Submissão de Ensaios Clínicos

Lançamento do Projeto-piloto de Submissão de Ensaios Clínicos

FONTE : INFARMED .04 mar 2021 Circular Informativa Conjunta N.º 003/CD/100.20.200, de 26/02/2021   Com o objetivo de se proceder à implementação em Portugal do Regulamento (UE) n.º 536/2014, de 16 de abril, relativo aos ensaios clínicos de medicamentos de uso...