NOTICIAS

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...

Clinical Trials Information System (CTIS):  EMA training programme

Clinical Trials Information System (CTIS): EMA training programme

Training is available from the European Medicines Agency (EMA) on how to use the Clinical Trials Information System (CTIS) ahead of its planned launch. EMA’s training resources are tailored for clinical trial sponsors and staff of the European Union (EU) Member...

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...