More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.

Elicitation of Expert Knowledge for Controlling Subjectivity in Risk-based Decision Making

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel.

Using a Third Party to Perform Audits

The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.

 The EU AI Act

Topic

Feliza Mirasol is the science editor for 

Articles

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)

This is the second biologic approved to treat HS, a painful and reoccurring skin disease. 

New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval

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

The EC is calling for interested parties for their safety and orphan drug committees.

European Commission Searches for Committee Experts

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

ATCC and USP Launch Six Products Used to Detect Residual Host Cell Genomic DNA

Prasanth Sambaraju is an independent researcher based in Hyderabad, India. 

One of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability. 

Pooling of Batches for Stability Data Analysis

Editor of Pharmaceutical Technology Europe

A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.

Breathing Easier

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

The EU AI Act

Chris Spivey is the editorial director of 

Videos

Pharmaceutical Technology Europe® spoke with Joren van der Horst from Luo Automation, a Dutch company focused on automated visual inspection solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Making Visual Inspection Accessible with Luo Automation at CPHI Barcelona

H. Gregg Claycamp, MS, PhD, is a Risk and Decision Analysis Consultant, hgclaycamp@gmail.com.

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making. 

Elicitation of Expert Knowledge and Probabilities for Controlling Subjectivity in Risk-Based Decision Making

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

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel. 

Quality Systems

Elicitation of Expert Knowledge for Controlling Subjectivity in Risk-based Decision Making

Using a Third Party to Perform Audits

The EU AI Act