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

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Articles

The license holder should negotiate, educate, contract, and then oversee 
the transportation contractor, says Siegfried Schmitt, vice president, Technical at Parexel. 

Ensuring Contractors Perform Good Distribution Practices

Feliza Mirasol is the science editor for 

Videos

This discussion explores how the management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process within the biopharma industry.

Drug Digest: The Rush for Quality Data and the Means to Protect It

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

Europa Perspectives: EMA Transparency in Investigating CAR-T Secondary Cancers

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

EMA Recommends New ALS Treatment

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

Europa Perspectives: Helping to Navigate the Regulatory System

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

FDA’s Drug Safety Priorities for 2023

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

FDA Approves Amtagvi, First Cell Therapy for Skin Cancer

Steffen Thirstrup, chief medical officer at the European Medicines Agency, provides insight on regulatory challenges in Europe.

European Medicines Agency Viewpoint

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

EMA and HMA Launch Real-Word Data Catalogues

Iain McGhee is vice president of Quality at Ascend.

This article looks at the relationship between a CDMO quality organization and the client.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments