NOTICIAS

MDR Guidance Addresses Transitional Provisions

MDR Guidance Addresses Transitional Provisions

The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to further explain Article 120(2) of the EU Medical Devices Regulation (MDR), which says that certificates issued in accordance with the previous device directives will...

EC  MDR Guidance on New Safety and Clinical Performance Summary

EC MDR Guidance on New Safety and Clinical Performance Summary

The main purpose of this document is to provide guidance on the presentation,content and validation of the SSCP. The word “shall” is used when there is a corresponding “shall” in the MDR, otherwise “should” or “recommended” etc. is used indicating the interpretation...

Regulatory Submissions for Medical Devices in Electronic Format

Regulatory Submissions for Medical Devices in Electronic Format

This document provides guidance on FDA’s interpretation of the statutory requirement for  submission in electronic format; however, this document also contains guidance on additional  submission types for which submission in electronic format is anticipated to be...

EMA’s work on new veterinary regulation advances

EMA’s work on new veterinary regulation advances

PUBLISHED BY EMA News 23/09/2019 EMA has launched a new webpage that shows the progress made by the Agency in the implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes applicable on 28 January 2022. On this webpage,...

Regulating medical devices in the event of a no-deal Brexit

Regulating medical devices in the event of a no-deal Brexit

This guidance will apply from exit day in line with the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 . This guidance sets out how medical devices will be regulated in the UK in a no-deal Brexit scenario. In a no deal scenario the UK’s current...

PARCERIA ADIFA  e FORMIVENTOS

PARCERIA ADIFA e FORMIVENTOS

A ADIFA , Associação  de Distribuidores Farmacêuticos, respondendo ao  objetivo de contribuir para a melhoria das competências profissionais dos seus associados; tem estabelecida  uma parceria com a Formiventos para oferecer-lhes condições  especiais para o acceso aos...

EudraVigilance Operational Plan: Milestones 2018 to 2020

EudraVigilance Operational Plan: Milestones 2018 to 2020

EudraVigilance is the central pillar for pharmacovigilance activities in the European Economic Area (EEA). In February and April 2017, the new EudraVigilance system successfully passed an independent audit in accordance with Article 24 of Regulation (EC) 726/2004. The...

CDRH regulatory science priorities

CDRH regulatory science priorities

CDRH regulatory science priorities : Leverage “Big Data” for regulatory decision-making . Modernize biocompatibility and biological risk evaluation of device materials Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory...

EC revised SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE

EC revised SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE

The European Commission  issued a revised questions and answers guideline on implementing safety features for medicinal products detailed in Commission Delegated Regulation (EU) 2016/161.   The revised document includes three new questions and answers as well as one...

Transforming Regulatory Operations

Transforming Regulatory Operations

Posted 17 July 2019 | By Eckart W. Schwarz, MD, Adrian Cottrell, PhD  Regulatory Focus™ This article describes one global pharmaceutical company’s efforts to improve efficiencies, maintain compliance with new standards and gain greater internal alignment. By...

How To Recognize Effective CAPAs And A Culture Of Quality

How To Recognize Effective CAPAs And A Culture Of Quality

Article | MED DEVICE ON LINE    ABOUT THE AUTHOR Leo Gelera, Quality Manager Leo joined FMI in March of 2012. Leo began his career in medical device manufacturing specifically working for Abbott and Baxter Healthcare. He dedicated his time to various quality...

Factsheet for Manufacturers of Medical Devices

Factsheet for Manufacturers of Medical Devices

This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In-VitroMedical Devices Regulation (IVDR) on manufacturers see the Factsheet for manufacturers of in-vitro diagnostic medical devices. References to Annexes and...

Quality requirements for drug-device combinations

Quality requirements for drug-device combinations

Draft guideline on the quality requirements for drug-device combinations (PDF/302.99 KB) Draft: consultation open First published: 03/06/2019 Consultation dates: 03/06/2019 to 31/08/2019 EMA/CHMP/QWP/BWP/259165/2019 Guidance is provided on dossier requirements for...

Questions and answers: Requirements relating to notified bodies

Questions and answers: Requirements relating to notified bodies

The European Commission (EC) issued a Q&A document  to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs). This document presents questions and answers on requirements relating to...

INFARMED Circular Informativa: Alegações em produtos cosméticos

INFARMED Circular Informativa: Alegações em produtos cosméticos

Os novos elementos contidos no documento técnico : Technical document on cosmetic claims,, são aplicáveis aos cosméticos disponibilizados no mercado a partir de 1 de julho de 2019.   Alegações em produtos cosméticos (Circular Informativa N.º 097/CD/550.20.001...

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 category of...

Real World Data e Real World Evidence

Real World Data e Real World Evidence

Estreitamente ligado a conceitos como Patient Centrity, a RWE está emergindo como uma área crítica de conhecimento nas empresas farmacêuticas, envolvendo várias funções, como HEOR, Medical Affairs, Market Access, R&D e comercial Real world data (RWD) e real world...

ICH  Revised Guideline on General Considerations for Clinical Studies

ICH Revised Guideline on General Considerations for Clinical Studies

The ICH document "General Considerations for Clinical Studies" is intended to:  1. Describe internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities...

DATA INTEGRITY in GxP enviroments: A Formação superou as expectativas

DATA INTEGRITY in GxP enviroments: A Formação superou as expectativas

Decorreu no passado dia 7 de maio a  3ª edição da formação sobre  DATA INTEGRITY in a GxP enviroments, bajo o lema "Procedimentos para assegurar a integridade dos dados, demonstrar a sua exactidão e coerência, e garantir a qualidade da informação". A integridade dos...

NOVA LEI DOS ENSAIOS CLÍNICOS

NOVA LEI DOS ENSAIOS CLÍNICOS

NOVA LEI DOS ENSAIOS CLÍNICOS | Proposta de Lei n.º 199/XIII, que visa assegurar a execução, na ordem jurídica interna, do Regulamento (UE) n.º 536/2014 do Parlamento e do Conselho, de 16 de abril de 2014, relativo aos ensaios clínicos de medicamentos para uso...