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

Feliza Mirasol is the science editor for 

Articles

Digital transformation is allowing for better handling, analysis, and protection of vast data collection.

Shoring Up Data Integrity Practices

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

The IDAP pilot scheme is designed to accelerate access to innovative medical devices and is a pioneering legislative proposal in the UK medical device space.

Improving Patient Access Through the UK IDAP Scheme

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.



New FDA Draft Guidance Made Available for Materials Used in Manufacturing CGTs and Tissue-Engineered Therapeutics

The report covers the major achievements of the office during 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings.

CDER Releases Office of New Drugs 2023 Annual Report

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

Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel.

Emerging Therapies and GMPs

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

New FDA Draft Guidance Issued for Sponsors of Allogeneic Cell-Based Medical Products.

The agreement, which will allow participants to share confidential information on medical and medicinal products, builds on the cooperation fostered between the two regulatory authorities during the COVID-19 pandemic.

Confidentially Agreement Signed Between European Union and Republic of Korea Regulatory Bodies

The majority of PMCs/PMRs are proceeding according to schedule.

FDA Reports on Status of Postmarketing Requirements and Postmarketing Commitments

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

FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.

Novartis’ Radioligand Therapy Gains FDA Nod for Pediatric Patients 

Michele Duggan is senior manager, Regulatory Affairs, at Thermo Fisher Scientific.

Regulations for mRNA products are evolving as the market for mRNA expands. 

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments