Quality Systems

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.

Expert Panel Promotes Global Information Sharing

Sean Milmo is a freelance writer based in Essex, UK.

Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.


The Challenges for Regulators in the Digital Age

NICE has issued a positive recommendation for GW Pharmaceuticals’ Epidyolex (cannabidiol) oral solution for the treatment of seizures in patients with a rare form of childhood-onset epilepsy.


NICE Issues Positive Recommendation for Cannabidiol Oral Solution to Treat Epilepsy

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

An effective quality control unit is independent from manufacturing and ensures current standards are followed.

The Right Pieces for a Quality Program

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

After years of discussions around pricing, UK governmental bodies and Vertex have finally reached an agreement on cystic fibrosis treatments.


Striking a Landmark Deal

Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.


Investigating NDMA Impurities at EMA’s Request

Pfizer has issued a voluntary recall of batches of its docetaxel injection 80 mg/8 mL due to impurity concerns.

Pfizer Recalls Batches of Docetaxel Injection

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.

First Ebola Vaccine Gains Conditional Marketing Authorization Recommendation

CHMP has recommended that Baqsimi (glucagon), a non-injectable treatment for severe hypoglycemia, be granted marketing authorization in the EU.

CHMP Recommends EU Marketing Authorization for Baqsimi

Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.

Regulatory/GMP Compliance, Europe