From looking at ways to reduce the number of audits undertaken by companies to fulfil their pharmacovigilance obligations to calling for harmonized assessment of risk management plans, the EU generics and biosimilars industry group Medicines for Europe says it is ready to explore some radical proposals to simplify the current pharmacovigilance requirements.

Bayer’s ambitious campaign to reposition itself as a global leader in two complementary fields – health and nutrition – will face its toughest test in the US, with its highly litigious approach to product liability and a tendency to target pharmaceuticals as the source of the health system’s affordability and access problems.

Insights from Gates Medical Research Institute CEO Dr. Penny Heaton.