European Pricing Talks: A lot of Smoke or is it Fire?

Is it wrong for European pharma executives to worry about the risks of ever-tighter price controls on their products? Should they lightly dismiss signals of public and political concern over rising drug bills, disregarding them as merely exaggerated rhetoric from radical hotheads? Is the climate Powered by WPeMatico Continue reading European Pricing Talks: A lot of Smoke or is it Fire?

Identity Crisis: Data Protection Roles for Life Sciences Companies

James Clark The advent of the General Data Protection Regulation (GDPR) has brought with it a complicated range of challenges for businesses operating in life sciences. From transparency and privacy notices, to the use of consent, from contracts with service providers, to extended data Powered by WPeMatico Continue reading Identity Crisis: Data Protection Roles for Life Sciences Companies

Managing Local Language Regulatory Submissions

Few regulatory affairs heads would dispute the rising complexity of compliance and regulation in life sciences. Despite efforts to encourage consistency in international submissions, evolving priorities and variances in individual market demands are heaping the pressure on regulatory professio Powered by WPeMatico Continue reading Managing Local Language Regulatory Submissions

EMA Relocation Countdown: Some Industry Viewpoints

July 1, 2018 marked the start of the six-month countdown to the European Medicines Agency (EMA) relocation of its operations to Amsterdam. Worryingly, there remains little guidance or clarity from the EMA as to the implications of the move, and Brexit, on the pharma industry. Three industr Powered by WPeMatico Continue reading EMA Relocation Countdown: Some Industry Viewpoints

Can Trump Plan Serve as Model for What Ails Europe?

Now Donald Trump has at last made his pitch to tackle the challenge of paying for drugs in the US, speculation is rife about what the impact could be around the world and healthcare payers in Europe are combing through his 44-page blueprint to see if any of his ideas might be worth a try locally Powered by WPeMatico Continue reading Can Trump Plan Serve as Model for What Ails Europe?