RESOURCES LIBRARY

Whitepapers, Guidelines, Legislação, Artigos

Data Integrity and Compliance With Drug CGMP

FDA expects that all data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement  meaningful and effective strategies to...

Data Management Fundamentals for Your Next Clinical Trial

Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process related to the development candidate. Therefore, for any sponsor, paying close attention to the data management aspects of clinical operations should...

EMA Guideline on GVP Considerations for Pediatric Populations

New legislation for pharmacovigilance applies in the European Union (EU) since July 2012, and to support its implementation, a set of guidelines for the conduct of pharmacovigilance in the EU has been developed which, as they have been adopted, replaced the previous...

Guidance on UDI for systems and procedure packs

New regulations Guidance document to assist stakeholders in implementing the Medical Devices Regulations. MDCG 2018-3 Guidance on UDI for systems and procedure packs MDCG 2018-4 Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for...

The Essential Guide To Electronic Informed Consent

This e-book has been designed as an introduction to electronic informed consent (eConsent) in clinical trials for those researchers considering making the switch from traditional paper-based processes. The Essential Guide To Electronic Informed Consent

THE RACE TO EU MDR COMPLIANCE

An industry survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS) found little familiarity with the European Union’s new Medical Device Regulation and its requirements that take full effect in May 2020. read the survey  :THE RACE TO EU MDR...

Perguntas e respostas sobre o sistema dos dispositivos de segurança

Este documento pretende informar sobre o entendimento do INFARMED, I.P. relativamente às questões mais colocadas pelas entidades sobre a implementação dos dispositivos de segurança nas embalagens de medicamentos de usos humano. Download: Perguntas e respostas sobre o...

Principles of Labeling for Medical Devices and IVD Medical Devices

The purpose of this IMDRF guidance is to provide globally harmonized labeling principles for medical devices and IVD medical devices and support the IMDRF Essential Principles of Safety  and Performance. Specifically, this document provides guidance on the content of...

Unique Device Identification system (UDI system) Application Guide

The IMDRF UDI Guidance (IMDRF/WG UDI/N7Final:2013) provides a framework for the regulatory authorities that intend to develop their UDI systems in a globally harmonized approach. This UDI system Application Guide is to be used as a supplement to the IMDRF UDI Guidance...

Technical document on cosmetic claims

The purpose of this document is to provide guidance for the application of Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products. Technical document on cosmetic claims Agreed by the...

Updated: ICH Q12: A Framework for Managing Post-Approval CMC Changes

The US Food and Drug Administration (FDA) made available an International Council for Harmonisation (ICH) draft guidance on technical and regulatory considerations for pharmaceutical lifecycle management. Q12 Technical and Regulatory Considerations for Pharmaceutical...

DATA INTEGRITY REFERENCES

REFERÊNCIAS: .-EMA: Questions and answers: Good manufacturing practice - Data Integrity Section .-FDA: FDA Data Integrity Guidance .-MHRA: MHRA Data Integrity Definitions and Guidance .-PIC/S: PIC/S Guidance .-WHO: WHO Guidance

ISO 13485 :2016 Versão para download

A norma ISO 13485 tem como objetivo  garantir o cumprimento dos requisitos legais, a gestão dos riscos e a manutenção dos processos de projecto, produção e distribuição de dispositivos  médicos. A Formiventos disponibiliza a nova versão para download : Medical devices...

PGEU Best Practice Paper: Pharmacovigilance and Risk Minimisation

This best practice paper outlines the evolution of pharmacovigilance in Europe, particularly in the context of the fifth anniversary of the 2012 EU pharmacovigilance legislation and recent developments in the field. Additionally, this paper describes the varied role...

DATA INTEGRITY REFERENCES

.-EMA: Questions and answers: Good manufacturing practice - Data Integrity Section .-FDA: FDA Data Integrity Guidance .-MHRA: MHRA Data Integrity Definitions and Guidance .-PIC/S: PIC/S Guidance .-WHO: WHO Guidance

Looking to the Future in Regulatory Affairs

By Oliver Cox and Siegfried Schmitt, PhD Predicting the future is, of course, like gazing into a crystal ball; therefore, the reader is warned that the following is based in part on indicators from industry and the regulators, but mostly on personal considerations and...

New rules for Novel Food

REGULATION (EU) 2015/2283 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2015 .on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of...