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...
Innovative Designs in Early Phase Oncology Studies

International – Innovative Designs in Early Phase Oncology Studies

Advancements in science and technology combined with unmet patient needs are driving accelerated timelines and creative pathways for oncology drug development. Oncology sponsors and...
Examining US FDA criteria for medical device cybersecurity and risk management

International – FDA to Follow EMA With Move From London to Amsterdam

As the US Food and Drug Administration (FDA) now communicates with its European counterparts on a daily basis, the US agency has decided to...
Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)

International – ICH Drafts Revised Guideline on General Considerations for Clinical Studies

With a focus on modernization, the International Council for Harmonisation (ICH) on Thursday released for public consultation a draft version of its guideline E8(R1)...
Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas

International – Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas

As part of plans to lower the cost of prescription drugs, the US Department of Health and Human Services (HHS) and the Food and...

International – Improving Access to CAR T Therapy: It’s Not Just Payment

The development of chimeric antigen receptor (CAR) T therapy for patients with advanced hematological malignancies represents one of the greatest successes in bringing basic...

International – How regulators have adapted globally to clinical trials for drugs and biologics...

The COVID-19 pandemic has disrupted clinical trials globally and has resulted in a 65% worldwide decrease in new patient enrollment year-over-year during March 2020....

International – Advanced therapies: ‘Trip hazards’ on the development pathway

This article concerns the development of advanced therapies and the challenges and complexities of getting them through the developmental pathway, which the authors call...
Updated: FDA, Health Canada and EMA Spot Second Impurity in Valsartan

International – Updated: FDA, Health Canada and EMA Spot Second Impurity in Valsartan

Following the identification of an impurity known as N‑nitrosodimethylamine (NDMA) in the blood pressure-lowering medicine valsartan, FDA, EMA and Health Canada announced Thursday that...
EU files WTO dispute with Turkey over pharma laws

International – EU files WTO dispute with Turkey over pharma laws

According to Commissioner for Trade Cecilia Malmström, Turkey is effectively forcing manufacturers of pharmaceuticals to move production into the country if they want their...

NOS PROCHAINES FORMATIONS