Topic

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

Articles

Taking stock on the ‘big-ticket’ news items, both good and bad, from the past 12 months.

The Good, The Bad, and The Brexit

Daniel Erickson is Product Strategy Manager at ProcessPro.

An ERP solution provides for the management of multiple business activities and traceability requirements resulting from regulations, customer demands, sourcing, and international business needs.

Enterprise Resource Planning Systems Provide Supply Chain Traceability

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

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL. 

User Requirements Specifications–How Difficult Can It Be?

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Survey results and record attendance show positive signs for various bio/pharma regions.

Innovation and Industry Strength Recognized at CPhI

… Brexit may be a bumpy ride. Here, the new European editor of the PharmTech Group, Felicity Thomas, discusses Brexit and its implications for the pharma industry.

Fasten Your Seatbelts …

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

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.

The Link Between Data Integrity and Quality Culture

In the second half of CPhI’s annual report, experts review industry trends and warn that trade and patent changes could increase healthcare cost by $100 billion over the next five years.


Experts Suggest Trade and Patent Changes Could Increase Healthcare Cost by $100 Billion

Steve Stein is lead research specialist, 3M Drug Delivery Systems

Advances in medicine and consumer electronics can enhance drug delivery and patient care.

Viewpoint: The Driver of Drug Delivery

Sharing know-how can help resolve common bio/pharma technical challenges.

Be a Part of the Solution

Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.

Nancy Lewen is research fellow, CSD Analytical chemistry, Bristol-Myers Squibb.

Elisabeth Corbett is associate director, Global Regulatory Sciences, CMC, Bristol-Myers Squibb.

Lina Wong is associate director, Global Quality Assurance, Allergan.

Shoreh Shabrang is senior consultant RA CMC, SAABAS LLC.

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

Viewpoints