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NOTICIAS

European Commission Newsletter on medical devices | September 2023

European Commission Newsletter on medical devices | September 2023

This newsletter from the European Commission aims to provide highlights and updates from the medical devices (MDs) and in vitro diagnostic medical devices (IVDMDs) sector. In this edition, you will find updates on the September’s session of the International Medical...

INFARMED Esclarecimentos: Medicamentos essenciais de natureza crítica

INFARMED Esclarecimentos: Medicamentos essenciais de natureza crítica

O presente documento visa clarificar algumas questões relacionadas com a redação da Portaria n.º 235/2023, de 27 de julho, a qual determina a possibilidade de aplicação de medidas específicas que visam garantir o acesso e a manutenção no mercado nacional de...

Labeling for Biosimilar and Interchangeable Biosimilar Products

Labeling for Biosimilar and Interchangeable Biosimilar Products

This guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products2 18 for submission in an application under section 351(k) of the  Public Health Service Act (PHS Act) (42 U.S.C. 262(k)) (351(k)...

Post-Warning Letter Meetings Under GDUFA Guidance for Industry

Post-Warning Letter Meetings Under GDUFA Guidance for Industry

  This guidance provides information on the implementation of the PostWarningLetterMeeting process for certain facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the...

EDQM TRAINING MODULE 7  Control of impurities: CEP approach

EDQM TRAINING MODULE 7 Control of impurities: CEP approach

This module addresses in detail how to  hashtag#controlimpurities  in  hashtag#activesubstances  in the context of a  hashtag#CEPapplication . The presentation outlines how to build and justify an appropriate control strategy, not only for  hashtag#organic  and...

The state of AI in 2023: Generative AI’s breakout year

The state of AI in 2023: Generative AI’s breakout year

Published by McKinsey Insights   The latest annual McKinsey Global Survey on the current state of AI confirms the explosive growth of generative AI (gen AI) tools. Less than a year after many of these tools debuted, one-third of our survey respondents say their...

Innovation in Data-Driven Health Care

Innovation in Data-Driven Health Care

Harvard Business Publishing: https://hbr.org/sponsored/2023/08/innovation-in-data-driven-health-care   Innovative uses of data in health care are helping solve the most challenging problems in patient health and operational efficiency. Today, many health care...

Revisão das Boas Práticas Regulamentares

Revisão das Boas Práticas Regulamentares

25 JULHO 2023. ORDEM  DOS FARMACÊUTICOS O Conselho do Colégio de Especialidade de Assuntos Regulamentares da Ordem dos Farmacêuticos (CCEAR-OF) atualizou o guia de Boas Práticas Regulamentares, cuja primeira edição foi publicada em março de 2004. Excetuando o capítulo...

GUIDANCE DOCUMENT  Qualification of Medical Device Development Tools

GUIDANCE DOCUMENT Qualification of Medical Device Development Tools

This guidance describes a voluntary program for the qualification of medical device development tools (MDDTs) for use in the evaluation of devices regulated by CDRH.  Specifically, this guidance describes the framework for voluntary proposal and qualification of an...

CEP 2.0: implementation date

CEP 2.0: implementation date

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce that the CEP 2.0 will be implemented on 1 September 2023. From that date onwards, new dossier applications and renewal applications will receive a CEP 2.0, whereas...

EUROPEAN COMMISSION European Innovation Scoreboard 2023.

EUROPEAN COMMISSION European Innovation Scoreboard 2023.

Bold policies and increased investments in Research & Development are necessary to contribute to the success of Europe’s digital and green agenda. This can help enhance resilience and technological sovereignty, and strengthen the competitiveness of our single...

Artificial intelligence act

Artificial intelligence act

Briefing 28-06-2023 The European Commission tabled a proposal for an EU regulatory framework on artificial intelligence (AI) in April 2021. The draft AI act is the first ever attempt to enact a horizontal regulation for AI. The proposed legal framework focuses on the...

EU HEALTH COALITION Manifesto for a Healthier Europe

EU HEALTH COALITION Manifesto for a Healthier Europe

On the heels of the most severe pandemic in decades, European healthcare systems are facing a perfect storm of ageing populations, growing prevalence of chronic diseases, significant health workforce shortages, and the unfolding energy, climate, cost of living, and...

ANVISA : Manual de Importação de Dispositivos Médicos

ANVISA : Manual de Importação de Dispositivos Médicos

  O manual tem o objetivo de orientar os importadores sobre as regras para submissão e os procedimentos de análise de processos de importação de dispositivos médicos sob responsabilidade do Posto de Anuência de Importação de Produtos para Saúde (PAFPS). Os...

ICH has announced plans to work on three new topics this year covering patient preference studies, non-clinical safety studies for oligonucleotide-based therapeutics and bioequivalence studies for modified release products.

ICH has announced plans to work on three new topics this year covering patient preference studies, non-clinical safety studies for oligonucleotide-based therapeutics and bioequivalence studies for modified release products.

Press Release: ICH Assembly Meeting, Vancouver, Canada, June 2023 20 June 2023 New Areas of Harmonisation Adopted, Alongside Significant Advancement of Ongoing Activities The Assembly of the International Council for Harmonisation (ICH) met in-person on 12 & 13...

FDA Investigations Operations Manual 2023

FDA Investigations Operations Manual 2023

The Investigations Operations Manual (IOM) is the primary operational reference for FDA employees who perform field activities in support of the agency’s public health mission. Accordingly, it directs the conduct of all fundamental field activities. Adherence to this...