Topic

Articles

Patient consent is potentially tricky for pharma R&D to navigate as a result of new data protection rules in Europe.

Dual Aspects of Informed vs. Explicit Consent in R&D

Agnes Shanley is senior editor of Pharmaceutical Technology.

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

Continuous Manufacturing: Addressing the Tough Questions

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

FDA’s annual manufacturing report card shows more quality compliance is needed.

Pharma Facilities Still Have a Lot to Learn

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Quality Agreements and Out-of-Specification Investigations

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

Unknown and Unknowable

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.

Distinguishing Between Cleanroom Classification and Monitoring

Pharma delivers a positive message with renewed efforts to eradicate malaria.

Working for the Greater Good

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

Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.

Broadening Europe’s Research Horizons

Partha S. Anbil is a cognitive enterprise transformation leader (partha.anbil@ibm.com) with IBM’s Healthcare and Life Sciences practice.

Novartis, BMS, and other companies are reducing complexity by thinning out product portfolios. Reducing complexity can reduce waste and improve responsiveness, but it must be done right.

Improving Pharma Supply Chain Agility: A Lesson from the Retail Industry

Better drug design and patient education may promote improved personal and public health.

Viewpoints