NOTICIAS

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The US Food and Drug Administration (FDA) made available an International Council for Harmonisation (ICH) draft guidance on technical and regulatory considerations for pharmaceutical lifecycle management.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

BENEFIT-RISK ASSESSMENT IN DRUG REGULATORY DECISION-MAKING

Draft PDUFA VI Implementation Plan (FY 2018-2022) MARCH 30, 2018 U.S. FOOD AND DRUG ADMINISTRATION   As part of the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) under Title 1 of the FDA Reauthorization Act of 2017, FDA committed to furthering...

Conclusões da 3ª edição do curso “QUALIFIED PERSON”

A Formiventos celebrou no dia 23 de maio a 2ª Edição do Curso : QUALIFIED PERSON , conduzido pela reputada especialista Dra Fernanda Ralha, Diretora. Direçaõ de inspeção e Licenciamento do INFARMED; bajo o lema "Uma revisão do impacto das novas Regulamentações nas...

The MHRA has published its ‘GxP data integrity guide’

The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of...

Página 1 de 512345