Article | October 18, 2017

Regulatory Change Is Coming in the EU – Will You Be Ready?

Source: Medrio
Regulatory Change Is Coming in the EU – Will You Be Ready?

A recent article in Clinical Leader outlined concerns about Pharma’s ability to comply with the new EU Data Protection Regulation set to go into effect in May 2018. Indeed, companies doing business in the European Union will have major regulatory changes to contend with, including:

  • Increased territorial scope, which includes where data is processed and stored
  • Increased penalties, which can reach 4% of global profit
  • Strengthened patient consent

As the global reach of clinical trials has increased, and with the deadline for compliance quickly arriving, many in Pharma are finding themselves in a dilemma.