Viewpoints

Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.

Much has changed in the bio/pharma industry over three decades. In this special feature, the editors take a trip down memory lane, highlighting some of the major happenings of the past 30 years.

MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.

As drug supply chain security is of paramount importance, could radio-frequency identification solutions provide the optimal solution for pharma companies?

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

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

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

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

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

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

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

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.

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

More work needed to advance drug design and development effectively.

Uncertainty remains around the UK’s departure from the EU, potentially causing irreparable damage to the bio/pharma sector.

Do patients get what they pay for when they demand cheaper drugs?

As drug pricing comes under the microscope internationally, it appears that collaboration with all stakeholders is key to tackling the issue.

Biosimilars, pricing strategies, and technology will influence growth in spending on drugs.

Political instability is causing uncertainty in Europe and wreaking havoc with US regulatory timeframes.

The new year has started with a bang in terms of mergers and acquisitions.

Drug pricing and reimbursement concerns will continue to hinder industry growth in 2019, according to data and analytics company GlobalData.

Pricing pressures, investment volatility, and government disfunction greet Pharma in 2019.

Bio/pharma companies cannot spell success without solving all elements of quality programs.

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

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

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

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

… 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.

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.