Standards & Regulation

Is early and regular dialogue with regulatory agencies the key to success for smaller companies?

Research into rare diseases is on the rise, but are prices sustainable?

Serialization will enable our industry to take up its rightful place in the ‘Internet of Things’.

Is research into orphan diseases on the rise?

EMA’s pilot project continues. Is the future of regulation adaptive?

Pathways designed to bring medicines to market faster in Europe are not delivering the goods

Sitting Down With… William Chin, Executive Vice President, Scientific and Regulatory Affairs, Pharmaceutical Research and Manufacturers of America (PhRMA).

Biologic medicines present unique challenges for pharmacovigilance. And with biosimilars hitting the market, life just got more complicated.

Will FDA fast review and voucher incentives make a difference?

Quick fire Q&A with Hans-Georg Eichler, Senior Medical Officer, EMA