La Pharmacopée Européenne met à jour le contrôle de la contamination particulaire dans les préparations pharmaceutiques

Europe – La Pharmacopée Européenne met à jour le contrôle de la contamination particulaire...

En novembre 2019, lors de sa 165e session, la Commission européenne de Pharmacopée a adopté deux chapitres généraux relatifs au contrôle de la contamination particulaire dans les...
FDA Consolidates Nonclinical Immunotoxicity Evaluation Guidance

USA – FDA Consolidates Nonclinical Immunotoxicity Evaluation Guidance

The US Food and Drug Administration (FDA) on Wednesday issued a new draft guidance consolidating its recommendations on nonclinical safety evaluations for immunotoxicity and...
eCTD Technical Conformance Guide

USA – eCTD Technical Conformance Guide

This eCTD Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based electronic submissions to the...
Implementation of eCTD for clinical trial regulatory activities

Canada – Implementation of eCTD for clinical trial regulatory activities

The pilot for Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format concluded on August 31, 2019. Health Canada is pleased to...
FDA teams with India to stop counterfeit shipments

USA – FDA teams with India to stop counterfeit shipments

The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit,...
ICH S5 (R3) guideline on reproductive toxicology

Europe – ICH S5 (R3) guideline on reproductive toxicology

The purpose of this document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART)...
ICH E9 statistical principles for clinical trials

Europe – ICH E9 statistical principles for clinical trials

This document provides guidance on the design, conduct, analysis and evaluation of clinical trials of an investigational product in the context of its overall clinical development....
Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation

Europe – Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP)...

Sponsors (holders of the OMP designations) are advised to provide to the European Medicines Agency the following supporting information with their application for the...
Modernizing ClinicalTrials.gov: NIH Seeks Feedbackowser for precision medicine research

USA – Modernizing ClinicalTrials.gov: NIH Seeks Feedback

As part of a multi-year modernization initiative, the National Institutes of Health’s (NH) National Library of Medicine (NLM) is seeking comments from users and...
European Commission DG Health and Food Safety and European Medicines Agency Action Plan on ATMPs

Europe – European Commission DG Health and Food Safety and European Medicines Agency Action...

The term “advanced therapy medicinal products” (“ATMPs”) is used to designate gene therapies, somatic cell therapies and tissue engineered products. In the EU, these products...

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