International – Six Guiding Principles for Pharmaceutical Companies to Achieve Global Quality

Globalizing any technical function is a daunting proposition, so here I share a blueprint for successfully globalizing quality: six guiding principles distilled from decades...
The Q&A is divided into six sections

International – WHO Opens Consultation on New Biosimilar Q&A

As part of plans to clarify earlier biosimilar guidance, the World Health Organization (WHO) has drafted a new document outlining answers to questions regulators...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – Improving Biosecurity with first International Standard for Biorisk Management

SARS, pandemic viruses and threats of the malicious use of pathogens have all woken the world up to the risks of biological materials and...
Les Organoïdes supplantent désormais les méthodes In Silico dans la R&D

International – Les Organoïdes supplantent désormais les méthodes In Silico dans la R&D

Les recherches in silico (néologisme qui aurait été inventé en 1989) ont pour but de produire et présélectionner les médicaments potentiels ; elles ont le pouvoir d'accélérer...
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...
ASEAN Adds Philippine FDA to GMP Mutual Recognition Program

International – ASEAN Adds Philippine FDA to GMP Mutual Recognition Program

The Philippine Food and Drug Administration (FDA) has joined a regional mutual recognition program. As part of the Association of Southeast Asian Nations (ASEAN)...
Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations

International – Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations

This article discusses the scope and purpose of the special designation for Regenerative Medicine Advanced Therapies (RMAT) created by the passage of the 21st Century Cures...
4 Trends and Expectations for Drug Delivery in 2020

International – 4 Trends and Expectations for Drug Delivery in 2020

Recent years have seen considerable developments in the delivery of injectable medications. Modern patients, demanding drug therapies that are both effective and convenient to...
Valsartan prices double after recall

International – Valsartan prices double after recall

Prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States in September, following a...

International – Medical Writing: The Language and Art of Scientific Communication

Medical writers (MWs) are professionals from diverse backgrounds who address different business needs. Writers hone their skills over the years and master the art...

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