1
Science, medicine, digital technology, and data analytics are advancing at a
breathtaking pace. What was once the stuff of science fiction is fast becoming
reality. Whether it’s gene therapy, real-world data, electronic health registries, or
many other advances, the way medicine is practiced, and healthcare is delivered,
is changing rapidly.
Europe’s regulators, health technology assessment agencies, and payers are
racing to keep up with these developments as they work to assess, regulate,
approve, and reimburse for the latest scientific developments.
That puts pharmaceutical companies under mounting pressure to produce more
comprehensive evidence packages that satisfy two major forces: a growing
number of influential stakeholders with evolving demands and the traditional
regulatory review processes that still underpin approval decisions.
There’s a lot going on. But as the world around us changes, one thing remains
constant and more important than ever: the need for pharmaceutical companies
to communicate with clarity.
The ability of drugmakers to turn their complex evidence packages into a clear
and persuasive narrative—and outline a sensible pathway forward to address
their product’s limitations—is particularly acute when they are seeking approval
for their medicines from the European Medicines Agency (EMA).
Speaking with Clarity in an
Increasingly Complex, Rapidly
Evolving Environment
“Change is the only constant.”
Heraclitus
INTRODUCTION
Science, medicine, digital technology, and data analytics are advancing at a
breathtaking pace. What was once the stuff of science fiction is fast becoming
reality. Whether it’s gene therapy, real-world data, electronic health registries, or
many other advances, the way medicine is practiced, and healthcare is delivered,
is changing rapidly.
Europe’s regulators, health technology assessment agencies, and payers are
racing to keep up with these developments as they work to assess, regulate,
approve, and reimburse for the latest scientific developments.
That puts pharmaceutical companies under mounting pressure to produce more
comprehensive evidence packages that satisfy two major forces: a growing
number of influential stakeholders with evolving demands and the traditional
regulatory review processes that still underpin approval decisions.
There’s a lot going on. But as the world around us changes, one thing remains
constant and more important than ever: the need for pharmaceutical companies
to communicate with clarity.
The ability of drugmakers to turn their complex evidence packages into a clear
and persuasive narrative—and outline a sensible pathway forward to address
their product’s limitations—is particularly acute when they are seeking approval
for their medicines from the European Medicines Agency (EMA).
Speaking with Clarity in an
Increasingly Complex, Rapidly
Evolving Environment
“Change is the only constant.”
Heraclitus
INTRODUCTION