NOTICIAS

Medicamentos biossimilares na UE

The European Medicines Agency (EMA) and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar...

Postapproval Changes to Drug Substances Guidance for Industry

This guidance provides recommendations to holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and  abbreviated new animal drug applications (ANADAs) and holders of drug master files...

FDA´s final Guidance on Elemental Impurities in Drug Products

The U.S. Food and Drug Administration, FDA, recently published its final guidance on Elemental Impurities in Drug Products which finalizes the draft guidance issued July 1, 2016. The guidance provides recommendations regarding the required documentation related to the...

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...

Unique Device Identification system (UDI system) Application Guide

Authoring Group: IMDRF UDI WG Date: 12 July 2018   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...

AOS NOSSOS CLIENTES, MUITO OBRIGADO!

A Formiventos  tem vindo a contribuir desde 2012 para o desenvolvimento dos profissionais de  Portugal  colocando  à disposição das empresas a nossa especialidade: Soluções de Formação  com a maior Qualidade   Através da investigação contínua com os nossos clientes e...

Realizou-se com sucesso a 1ª Edição da formação DATA INTEGRITY

A Formiventos realizou a primeira Edição da formação :bajo o lema Data Integrity :Novas directrizes para controlar a integridade dos dados durante o fabrico e controlo dos medicamentos em laboratórios GMP, conduzida pela experiente  formadora Dra Teresa Cruz  da...

Conclusões da formação In-Company ” A Comunicão Carismática “

No passado dia 4 de junho  teve lugar a formação A COMUNICAÇÃO CARISMÁTICA: Liderar é influenciar pessoas de forma ética para conseguir resultados através das pessoas, nos escitórios do cliente, onde participaram 17 formandos com largo conhecimento e experiência na...

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...

Development of a Shared System REMS .Guidance for Industry

This guidance provides recommendations to industry on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) products.This guidance describes some of the possible benefits of a shared...

1.ª edição do Forum SERIALIZAÇÃO DO MEDICAMENTO marcada pelo sucesso

A Formiventos realizou  o dia 28 de maio  a primeira Edição do FORUM  SERIALIZAÇÃO do MEDICAMENTO, bajo o lema : Implicações da implementação em Portugal do ato delegado para a SERIALIZAÇÃO do MEDICAMENTO.   O Forum começou com a Intervenção Inaugural a cargo da Dra...

Bioanalytical Method Validation .Guidance for Industry

This guidance helps sponsors of investigational new drug applications (INDs) or applicants of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements validate bioanalytical methods used in human...

Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice

This guideline complements the Delegated Regulation (EU) No 2017/1569 of 23 May 2017, on good  manufacturing practice (GMP) for investigational medicinal products (IMP) and arrangements for  inspections, that has as legal basis the first subparagraph of Article 63(1)...

Creditada a Conferência sobre SERIALIZAÇÃO

O próximo 28 de Maio terá lugar a Conferência :Implicações da implementação em Portugal do ato delegado para a SERIALIZAÇÃO do MEDICAMENTO, bajo o lema : Qual é o melhor caminho para realizar a adequada implantação do sistema de serialização, de forma a garantir...

Draft guideline on clinical evaluation of vaccines – Revision 1

Summary This guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious diseases. It includes considerations for trials intended to document the safety, immunogenicity and efficacy of new candidate vaccines and to support changes...

Updated guidance: how to prepare a health claim application

EFSA has updated its advice for applicants on how to prepare and present a health claim application. The guidance presents a standardised format for a well-structured application. It also details the kind of information and data applicants need to submit in support of...

FDA Medical Devices Safety Action Plan

The Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health outlines a vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices throughout the TPLC, to provide for the timely communication...

FDA NEW GUIDANCE on Special Protocol Assessment

This guidance provides information on the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). SPA is a process in which...

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