Topic

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

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

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.

Articles

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. 

Using a Third Party to Perform Audits

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities. 

FDA Provides Guidance on Remote Facility Evaluations

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

FDA Approves Vaccine for Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

The treatment has received Priority Review designation, as well as FDA Breakthrough Therapy designation and Orphan Drug designation.

FDA Approves Novel Therapy for Rare Form of Blood Cancers

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

EMA Creates Mechanism for Support during Drug Shortages

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines. 

FDA Finalizes Guidance on Development of COVID-19 Vaccines

The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.

Lisata Therapeutics Announces EMA LSTA1 Orphan Drug Designation for Pancreatic Cancer Treatment

Feliza Mirasol is the science editor for 

Podcasts

In this episode of the Drug Solutions Podcast, industry experts discuss the challenges and advantages of the digitalization trend in the biopharma industry, with particular emphasis on the impacts to biomanufacturing.

Quality Systems