It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Computer Validation Confirms Evidence

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

Digitalization of QbD Risk Assessments

Topic

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

Tenosynovial giant cell tumor (TGCT) is rare and non-malignant, forming in or near joints, but which if left untreated can cause damage to joints and surrounding tissue, potentially leading to significant disability.

FDA Grants Full Approval for Symptomatic Tenosynovial Giant Cell Tumor Treatment

The agency has received certification with the Eco-Management and Audit Scheme for its commitment to environmental sustainability.

EMA Earns EMAS Certification

Feliza Mirasol is the science editor for 

The approval makes Evrysdi the first and only tablet for treating spinal muscular atrophy.

FDA Approves Evrysdi Tablet from Roche for Spinal Muscular Atrophy

The pledge signifies ArisGlobal’s commitment to upholding high standards and best practices for the responsible use of artificial intelligence.

ArisGlobal Signs European Commission’s AI Pact

Videos

Agnes Cwienczek, director of Product Management at ArisGlobal, talks with Pharmaceutical Technology® about how careers for women in STEM fields can be nurtured.

International Day of Women and Girls in Science: Fostering STEM Careers for Women

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

In this exclusive Drug Digest video interview Anil Kane from Thermo Fisher Scientific will be tackling the topic of advances in small-molecule manufacturing and several other experts will provide brief commentaries on associated topics. 

Drug Digest: Advances in Small-Molecule Manufacturing

With the approval, FDA granted SpringWorks a rare pediatric disease priority review voucher.

FDA Approves SpringWorks Therapeutics Treatment for Adult and Pediatric Patients with NF1-PN

Acoramidis was approved by FDA in November 2024 and is prescribed in the US under the brand name Attruby.

European Commission Approves BridgeBio Treatment for ATTR-CM

Pharmaceutical Technology® sat down with Kate Coleman from Arriello to run through the major trends from 2024, including the importance of technological advances, and how these may progress in 2025.

Industry Outlook 2025: Regulating Technology for the Future

The company is recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches because of possible multi-stacking of patches.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments