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?
Examining the key compliance challenges prevalent in the Asia-Pacific region and the unique country-by-country variations and adherence to the speak-up culture Although it is a longstanding business practice to divide international functions into a handful of huge geo Powered by WPeMatico Continue reading Asia s Complex Compliance Landscape
Europe slow to action on emerging technologies, but the complex issues clouding EHRs and gene editing, for example, offer pause Intheir perpetual game of catch-up with technology, European Union regulators recently trumpeted their plan to speed up the exchange of patients hea Powered by WPeMatico Continue reading Health Technology s Double-Edged Sword
The nation s rapidly changing regulatory climate is creating a new landscape for R&D and manufacturing service providers One marker of the pace of change currently under way in China was highlighted at the FT s annual Pharma and Biotech Conference in London in November. To Powered by WPeMatico Continue reading New Roads to China
Innovation forces upgrades in regulatory, quality, and standards to ensure the country is competing on a global level The pharmaceutical industry in China is definitely not a new thing, but for the past three to five years, there s a definite twist on the old thing. One that is Powered by WPeMatico Continue reading China: A Change in Attitude
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
Ashley Williams The General Data Protection Regulation (GDPR) came into effect on May 25, 2018 with its objectives being to reshape the relationship between organizations and individuals, reform the approach to how businesses handle personal data and to rehabilitate (sanction) organizat Powered by WPeMatico Continue reading Key Observations on GDPR
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
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
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?