Harmonization of global regulations fosters innovation and ensures quality medicines.

Convergence in the Global Regulatory Village

Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.

Shining a Light on Junior Pharmaceuticals

QMM provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.

Introduction to Pharmaceutical QMM Model

Topic

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

Articles

How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.

Never Mind the Statistics; Just Tell Me What the Answer Is! 

27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation. 

First Drugs Hit by Inflation Reduction Act Price Controls

Mike Wilson, QA/QC Strategy, Waters Corporation

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

Mitigating Human Error and Supporting Compliance with Smart Technology

Paul Van Tilborg is director of analytical sciences at Ardena.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Phase-appropriate Analytical Methodology

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

Quality Considerations for the Manufacture of Compounded Drugs

Pankaj Bhardwaj serves as a senior product manager Datafoundry for DF mSignal AI.

Ryanka Chauhan serves as a product manager at Datafoundry for DF mSignal AI.

By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.


Overcoming Data Gaps in Pharmacovigilance

CLiff Campbell is senior consultant at KPC.

Quality quartets support an integrated and stable combination of
commissioning and qualification and quality risk management processes.

Points to Consider for Knowledge Management Acceleration

Feliza Mirasol is the science editor for 

FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.

Acadia Pharmaceuticals Receives FDA Approval for First Treatment for Rare Genetic Disorder

FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine. 

FDA Approves Pfizer’s New Migraine Nasal Spray

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability. 

Quality Systems

Convergence in the Global Regulatory Village

Shining a Light on Junior Pharmaceuticals

Introduction to Pharmaceutical QMM Model