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Standards & Regulation

Business & Regulation Business Practice

Brexit: Preparing Is Caring

| James Strachan

Most, but not all, UK pharma companies are on track to keep their medicines on the European market by March, 2019.

Business & Regulation Standards & Regulation

Too Many Cooks

| Roisin McGuigan

Thought that most companies understood good manufacturing practice? Think again – there are always a few bad eggs.

Manufacture Business Practice

Make China Great Again

| James Strachan

China is upping its game with plans to revolutionize its manufacturing industries, including pharma.

Discovery & Development Standards & Regulation

The End of “Mini-Me” Medicine

| Andrew Parker

The end of “mini me” medicine is over, says Andrew Parker, because we can do better when it comes to pediatric care.

Business & Regulation Standards & Regulation

Ireland’s Brexit Trump Card

| Tommy Fanning

Tommy Fanning believes that Ireland’s pharma industry will continue to thrive, despite tax cuts in the US and Brexit.

Business & Regulation Business Practice

Ahead of the Curve

Sitting Down With... Ajaz Hussain, President, National Institute for Pharmaceutical Technology and Education, Minnesota, USA.

Manufacture Packaging

Track & Chase

| William Minaeff

Serialization deadlines will shortly be upon us – but, rather than entering into a blind panic, consider the long term.

Business & Regulation Advanced Medicine

FDA Quackdown

| James Strachan

Regulators step in to stop stem cell clinics from marketing unproven therapies.

Discovery & Development Biosimilars

What Regulators Want

| Bruno Speder

The path to market for a biosimilar involves an abbreviated approval process, focused on proving “biosimilarity”.

Manufacture Standards & Regulation

Stay Ahead. Smart Risk Management

Collaboration is crucial for supply continuity and control.

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May Issue of The Medicine Maker