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NOTICIAS

Autorização de Importação Paralela: revisão do procedimento

Autorização de Importação Paralela: revisão do procedimento

Publicado por INFARMED . www.infarmed.pt    07 dez 2022 Circular Informativa n.º 144/CD/100.20.200 de 07/12/2022   Conforme previsto no Estatuto do Medicamento, a Autorização de Importação Paralela (AIP) permite a comercialização de um medicamento...

MDCG 2022-17 : MDCG position paper on ‘hybrid audits’

MDCG 2022-17 : MDCG position paper on ‘hybrid audits’

This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).   It...

EU MDR News :  MDR implementation .Extension proposal

EU MDR News : MDR implementation .Extension proposal

EU Commission after listening to the different parties is now open to an extension of the transitional period with staggered deadlines depending on the product class. - 2027 for class III and IIb - 2028 for class IIa and I (upclassified)   Update regarding the...

ICH adopts Q13 guideline on continuous manufacturing

ICH adopts Q13 guideline on continuous manufacturing

 Objective This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification...

Statistical Approaches to Establishing Bioequivalence

Statistical Approaches to Establishing Bioequivalence

  Requirements for submitting bioavailability (BA) and bioequivalence (BE) data in investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements; the definitions of BA and BE; and the types of in vitro...

10º ANIVERSÁRIO FORMIVENTOS !

10º ANIVERSÁRIO FORMIVENTOS !

Em dezembro, celebramos mais um Aniversário e assim somamos 10 Anos de existência!   Juntamos mais 1 ano de histórias, experiências e aprendizagens. A Formiventos  é uma pequena familia de profissionais dedicados e comprometidos com a qualidade e a  inovação....

Clinical Trials Information System (CTIS) – Sponsor Handbook

Clinical Trials Information System (CTIS) – Sponsor Handbook

A compilation of key guidance, technical information, recommendations and references for getting ready for the use of CTIS Executive summary The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors representing pharmaceutical...

Artificial intelligence in European medicines regulation

Artificial intelligence in European medicines regulation

Published by    Artificial intelligence tools are increasingly being applied in the development and use of medicines. Here, we provide a regulatory perspective on such applications. The ability of artificial intelligence (AI) tools to generate new insights and...

NEW FDA PRESENTATION: How is My Medical Device Classified

NEW FDA PRESENTATION: How is My Medical Device Classified

To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device. There are two methods for accomplishing this: go directly to the classification...

A Formiventos é uma das Top 5% melhores PME de Portugal

A Formiventos é uma das Top 5% melhores PME de Portugal

É com grande satisfação que anunciamos que a Formiventos é uma empresa certificada TOP 5% MELHORES PME PORTUGAL, edição de 2022,  certificação atribuída pela SCORING, em termos de desempenho e solidez financeira. Este feito é motivo de orgulho para toda a equipa e...

An Introduction to FDA’s Regulation of Medical Devices

An Introduction to FDA’s Regulation of Medical Devices

  FDA NEW PRESENTATION: An Introduction to FDA’s Regulation of Medical Devices. Explain FDA’s role in regulating medical devices: • Define a medical device and review basics about device classification • Describe five steps to get a new product to market •...

MDR/IVDR IMPLEMENTATION ROLLING PLAN: Latest update: October 2022 

MDR/IVDR IMPLEMENTATION ROLLING PLAN: Latest update: October 2022 

MDR/IVDR IMPLEMENTATION ROLLING PLAN: Latest update: October 2022    Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This rolling plan contains a list of identified essential implementing acts and other relevant initiatives that the Commission has adopted...

FDA Advancing Real-World Evidence Program

FDA Advancing Real-World Evidence Program

As announced in the Federal Register notice published on October 20, 2022, FDA is conducting an Advancing Real-World Evidence (RWE) Program, which seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims,...

FDA new guidance on Postmarket Surveillance

FDA new guidance on Postmarket Surveillance

  Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the Food and Drug Administration (FDA) with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter...

Medicinal cannabis monograph proposed by US Pharmacopeia

Medicinal cannabis monograph proposed by US Pharmacopeia

A monograph outlining the analytical methods and acceptance criteria for cannabis chemotypes has been released for comment by USP’s Herbal Medicines Compendium.   The United States Pharmacopeia (USP) has opened a 90-day review period for their...

Digital Health Software Precertification (Pre-Cert) Pilot Program

In September 2022, the Software Precertification (Pre-Cert) Pilot Program was completed with the issuance of the Report: The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings. The FDA launched the Software...

FDA GUIDANCE DOCUMENT  : Clinical Decision Support Software

FDA GUIDANCE DOCUMENT : Clinical Decision Support Software

  Section 3060(a) of the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, amended section 520 of the Federal Food, Drug & Cosmetic Act (FD&C Act) to exclude certain medical software functions, including certain decision support software,...

Team-NB Position Paper on Hybrid Audit

Team-NB Position Paper on Hybrid Audit

New position paper released by Team-NB related to 'Notified bodies’ paper on the application of hybrid audits to quality management system assessments under MDR/IVDR'. Hybrid audits in the context of legislative requirements Notified bodies are required to undertake...

KPGM INSIGHTS : Medical devices 2030

KPGM INSIGHTS : Medical devices 2030

Published by KPMG   Stake your claim in the medical device value chain of the future and avoid the commodity trap. While the outlook for medical device companies appears positive, unsustainable healthcare costs and new competitive forces threaten to alter the...

Electronic Submission Template for Medical Device 510(k) Submissions

Electronic Submission Template for Medical Device 510(k) Submissions

  This guidance provides the further standards for the submission of premarket notification (510(k)) submissions by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a...