International – INSTITUT PASTEUR : Comment l’étude des mécanismes de multiplication du SARS-COV-2 permet...

Une initiative internationale regroupant des chercheurs de l’Université Californienne de San Francisco (UCSF), des Gladstone Institutes, de l’Icahn School of Medicine at Mount Sinai et de...

International – Using risk management to support outsourcing activities

This article outlines organizational risks and benefits with respect to third-party vendors and partnerships in regulatory affairs functions. It also discusses the different controls...
WHO drafts guidance for pharma supply chain tracking

International – WHO issues guidance for prequalified products amid COVID-19

The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract...

International – Guidelines for successful influencer marketing

Influencers are going to continue to be an important cog in the 2020 content marketing wheel despite the current crisis. Though large companies work with influencers regularly,...

International – Impurities : Guideline for Residual Solvents Q3C(R8)

Introduction 2-Methyltetrahydrofuran (2-MTHF, synonyms: 2-Methyloxolane, Tetrahydrosylvan; Tetrahydro 2-methylfuran; CAS Number 96-47-9) is a colourless, volatile liquid with ether-like odour. 2-MTHF is an organic solvent usually...

International – FDA, EU authorities update guidance on clinical trials during COVID-19

The European Commission and European Medicines Agency (EMA) on Tuesday updated their guidance on managing clinical trials during the coronavirus disease (COVID-19) pandemic, adding...

International – Et si la nicotine protégeait du Covid-19?

Tout a commencé par une intuition. «C’est le Dr Makoto Miyara, un de mes élèves, qui a attiré mon attention mi-mars sur le faible taux de...

Russia – La Russie annonce avoir développé un médicament contre le Coronavirus

Alors que l’épidémie du coronavirus se propage dans le monde, la Russie a annoncé hier lundi avoir développé un traitement contre le Covid-19 qui...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH adopts S11 guideline on nonclinical safety testing for pediatric drugs

The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety assessments to support the development of pharmaceuticals intended...
Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)

International – ICH E8 General considerations for clinical studies

The ICH guideline 'General considerations for clinical studies' is intended to describe internationally accepted principles and practices in the design and conduct of clinical studies that...

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