NOTICIAS

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...

Is an orphan medicine still an orphan once it gets on the market?

EMA publishes additional reports on decision-making for orphan medicines, an initiative that addresses requests from stakeholders. The new reports summarise the reasoning of the Agency’s Committee for Orphan Medicinal Products (COMP) on whether or not a medicine...

FDA Drafts PRV Guidance for Medical Countermeasures

This guidance provides information on implementation of section 3086 of the 21st Century Cures Act (Cures Act) (Public Law 114-255), which added section 565A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-4a). Section 565A of the FD&C Act...

Nova Creditação OF para o curso: Boas Práticas de Fabrico . GMP 2018

O curso Boas Práticas de Fabrico GMP 2018 para o próximo dia 30 de janeiro de 2018, conduzido pela reputada formadora Drª Fernanda Ralha, do Infarmed, foi creditado com 0.563 CDP   Nesta formação tem a oportunidade de ver abordados assuntos como : Novos conceitos e...

AVALIAÇÃO CLÍNICA de PRODUTOS de SAÚDE Lisboa, 17 de abril de 2018

Apresentamos a 2ª edição da formação AVALIAÇÃO CLÍNICA de PRODUTOS de SAÚDE, para o dia  17 de abril de 2018, conduzido pela reputada especialista Dra. Sónia Ferreira,Diretora Técnica.Diretora de Qualidade.Responsável de Farmacovigilância, da A. MARTINS & FERNANDES...

Actualização nas BOAS PRATICAS DE FARMACOVIGILÂNCIA

Final GVP modules Document(s) Language Status First published Last updated Effective Date Guideline on good pharmacovigilance practices: Module I – Pharmacovigilancesystems and their quality systems (English only) adopted 25/06/2012 02/07/2012 Guideline on good...

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...

Refuse to File: NDA and BLA Submissions to CDER

The purpose of this guidance is to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA (21 CFR 314.101(d)) or a biologics license application (BLA) or...

FDA promotes faster digital health regulation

The purpose of this guidance is to identify the types of decision support software functionalities  that: (1) do not meet the definition of a device as amended by the Cures Act; (2) may meet the  definition of a device but for which FDA does not intend to enforce...

FDA Guidance : Pediatric rare diseases

The emergence of concomitant trials for multiple investigational drug products for the treatment of rare diseases can pose significant challenges to effective drug development due to the limited number of patients worldwide with any given rare condition. The purpose...

FDA eCTD TECHNICAL CONFORMANCE GUIDE

Guidance for Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications...

Guidance to help pharma companies prepare for Brexit

Additional guidance relates to medicines for human and veterinary use The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). The guidance...

FDA Updates Orange Book With Patent Submission Dates

FDA introduces patent submission date updates to the Orange Book On November 21, 2017, the U.S. Food and Drug Administration (FDA) introduced an important data update to Approved Drug Products with Therapeutic Equivalence Evaluations – known as the “Orange Book.”...

New guidelines on good manufacturing practices for advanced therapies

Adaptations ensure a high level of quality for ATMPs and patient protection The European Commission has published a set of guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products (ATMPs). ATMPs are medicines for human use that...

Data Integrity – Implementation status

Checking the regulations and newsletters available for the pharmaceutical industry, data integrity is still the most prominent topic. Driven by various inspections since 2012/2013 this trend has meanwhile arrived at small and medium sized pharmaceutical companies. As...

New EudraVigilance system is live

Better safety monitoring for patients across Europe The European Medicines Agency (EMA) has launched today a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied...

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...

FDA Announces Streamlined Review Pathway for DTC Genetic Tests

At a time when people are more aware of and engaged in their health care than ever before, genetic risk testing can provide helpful information about an individual’s predisposition for certain diseases and conditions. These tests can prompt consumers to be more...

FDA to Recognize 8 EU Regulators to Conduct GMP Inspections

The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable...

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