Viewpoints

ISPE and PDA take on the challenge of recommending quality metrics.

Generics, market dynamics, and global demand are changing drug spending patterns.

GDUFA is off to a good start from a facility inspection perspective, but there are storm clouds on the horizon.

Scientists can share time and pharmaceutical knowledge with high school students.

The JOBS Act and FDASIA show early signs of accelerating drug development.

Ireland?s life-sciences sector has grown significantly since the 1960s. To gain insights into the competitive edge that Ireland offers to the pharmaceutical industry, Pharmaceutical Technology Europe spoke with Barry Heavey from IDA Ireland, which is a government agency responsible for attracting pharmaceutical and biotech companies to Ireland.

Through its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.

There has been a notable shift in interest for life-science companies over recent months from institutional investors investing through the public markets, but any plans to release further capital will rely on first-rate R&D.

PDA/FDA regulatory conference promotes a commitment to quality.

As the Supreme Court ruled on generic-drug liability, FDA outlined new rules for warning labels.

Orphan drugs for rare diseases are a major area of investment for pharmaceutical companies, but are they becoming too expensive for Europe to afford them?

Pharma and biotech companies, with the rest of the health care industry, must face change.

As the dreaded patent cliff continues to haunt the pharmaceutical industry, some companies are resorting to desperate measures to delay generic drug entry into the market.

With downsizing occurring more frequently than ever within the pharmaceutical industry, is Europe doing enough to curb further job losses that could threaten the recovery of its economy?

Ranbaxy's $500 million settlement for producing adulterated drugs and fradulent data provides a cautionary tale for patients, FDA, and drug manufacturers.

Drug companies team up with INTERPOL to keep counterfeit medicines off the Internet and out of the hands of patients.

Wanted: Article contributions on drug and process development topics.

The outlook of the European biotech sector may not be as bleak as apparently believed despite the current economic climate, but compared with their US rivals, biotech companies are still struggling to attract investors and secure funding.

Sound policies are needed to govern the substitution of interchangeable biologics.

Conference and exhibits provide a meeting place for professionals to exchange ideas.

QbD paradigm advances process understanding in development and manufacturing.

Has Europe's Innovative Medicines Initiative been successful in alleviating concerns regarding the region?s levels of pharmaceutical innovation?

The ongoing economic crisis in Europe has accelerated healthcare cost-containment measures targeting the price of pharmaceuticals, but the pharma industry is not giving in without a fight.

From time to time, it's important to take stock of the industry from both a retrospective and prospective point of view.

Vaccine manufacturing was predicted in 2008 to be on the cusp of a golden era, but instead the industry has experienced cost pressures, high-profile liability cases and production setbacks.

Nathan Jessop reviews the pharmaceutical industry's experience with the first year of Germany?s new pricing policy.

To ensure the accuracy of scientific testing, protect the subjects to avoid data contamination.

Even when all is well at the facility, one must expect the worst while braving the elements.

A disciplined approach to changing behavior can achieve change agility.

Global tactics that incorporate online technologies and social media are reshaping disease response.