NOTICIAS

PROMOTIONAL REVIEW : Mais uma edição marcada pelo sucesso

PROMOTIONAL REVIEW : Mais uma edição marcada pelo sucesso

Ontem, tivemos o prazer de realizar uma nova edição da formação exclusiva da FORMIVENTOS  sobre o PROMOTIONAL REVIEW de Medicamentos :  COMPLIANCE & BEST PRACTICES, com uma visão global da legislação ,  para consolidar e rever casos específicos da revisão de...

EIC 2025 work programme

EIC 2025 work programme

  The European Commission adopted the 2025 work programme of the European Innovation Council. It opens funding opportunities worth over €1.4 billion for strategic technologies and scaling up companies. The European Innovation Council and SMEs Executive Agency...

FDA drafts guidance on drug interaction labeling

FDA drafts guidance on drug interaction labeling

The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and biological product labeling as well as how drug interaction information...

European medicines agencies network strategy to 2028

European medicines agencies network strategy to 2028

EMA and the Heads of Medicines Agencies (HMA) have published their draft joint EU network strategy to 2028 for an eight-week public consultation. This is a review and update to the original five-year strategy, which was developed to cover the period 2021 to 2025...

EUDAMED user guide Guidelines on Data Exchange with EUDAMED

EUDAMED user guide Guidelines on Data Exchange with EUDAMED

The purpose of this document is to help Competent Authorities, Notified Bodies, as well as all Economical Operators (Manufacturers, Authorised Representatives, Importers, and System/Procedure Pack Producers) in assessing the most cost-efficient solution for their...

Guidance for best practices for clinical trials

Guidance for best practices for clinical trials

This document responds to requests by the World Health Assembly to the Director-General in resolution WHA75.8 (2022) on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination to identify...

IMDRF Document Implementation Report

IMDRF Document Implementation Report

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims...

New FDA Guidance on Biocompatibility Testing of Medical Devices

New FDA Guidance on Biocompatibility Testing of Medical Devices

Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff September...

FDA GUIDANCE: STUDY DATA TECHNICAL CONFORMANCE GUIDE

FDA GUIDANCE: STUDY DATA TECHNICAL CONFORMANCE GUIDE

  This Document is incorporated by reference into the following Guidance Document(s): Guidance for Industry Providing Regulatory Submissions in Electronic SEPTEMBER 2024 This Guide provides technical recommendations to sponsors4 for the submission of animal and...

IMDRF Document Implementation Report

IMDRF Document Implementation Report

The IMDRF Management Committee has today uploaded "IMDRF Document Implementation Report" This document provides a report on the status of implementation of all IMDRF technical documents as self-identified by IMDRF members as of the date of publication

Acceptable Media for Electronic Product User Manuals

Acceptable Media for Electronic Product User Manuals

FDA is issuing this guidance to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. This is done to recognize that electronic media are now being widely used to provide instruction, while at the same time...

MDSAP AUDIT APPROACH UPDATED.  Revision Date: 2024-08-06.

MDSAP AUDIT APPROACH UPDATED. Revision Date: 2024-08-06.

The design of the Medical Device Single Audit Program (MDSAP) audit process is to ensure a single audit will provide efficient yet thorough coverage of regulatory requirements. These requirements include; Medical devices – Quality management systems – Requirements for...

Clinical Trials Information System (CTIS) – Sponsor Handbook

Clinical Trials Information System (CTIS) – Sponsor Handbook

The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors  representing pharmaceutical industry, SME (small and medium-sized enterprises), academia, research organisations and other clinical trial sponsor organisations with the...