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

Roche voluntarily recalled Susvimo’s ocular implant, insertion tool, and initial fill kit when test results did not satisfy company standards.

Roche to Reintroduce nAMD Treatment in US After FDA Approves Updates

Kevin O’Donnell is Market Compliance Manager at Ireland’s Health Products Regulatory Authority.

Umit Kartoglu is president and CEO, Extensio et Progressio,
Collonge-Bellerive, Switzerland.

This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment. 

QRM, Knowledge Management, and the Importance of ICH Q9(R1)

Mike Hennessy Jr. is the President and CEO of 

A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.

Publisher's Note: With Age Comes Wisdom

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

Communication and meetings with FDA after receiving a warning letter 
demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.


Post-Warning Letter Interaction with FDA

Feliza Mirasol is the science editor for 

GSK’s application for using Jemperli (dostarlimab) plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer has been accepted by the EMA.

GSK’s Application for Jemperli Plus Chemotherapy for Use in All Patients with Endometrial Cancer Accepted by EMA

Life sciences data sets can be vast and complex to process, but up to now bringing intelligent automation systems up to speed and validating them has felt debilitatingly onerous. Large language models tackle these barriers head on. Ramesh Ramani and RaviKanth Valigari, technology innovators at ArisGlobal, explain.

Beyond GenAI: The Training-Free Discovery Potential of LLMs in a Drug Safety and Regulatory Context

The US currently relies heavily on imports from China and other overseas nations for APIs needed to manufacture drug products of critical importance to US patients.

NIPTE Strategy Aims to Mitigate US Pharma Supply Chain Risk

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

First Nasal Adrenaline Spray Among EMA Approvals in June

The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.

Participants for START Pilot Program Selected by FDA

Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments