Pharma regulation

Market Access

Approaching the regulatory world with passion: CERs and EU M...

There has been significant evolution in the European regulatory landscape over the past 10 years, particularly in terms of requirements for clinical evaluation, driven in part by

Market Access

Managing the challenges and embracing the opportunities of E...

The way HTAs are conducted in Europe is changing. And, if organisations act now to overcome the challenges, they could reap the rewards for years to come.

Market Access

DSCSA & dispensers: In the relay race of compliance, how to ...

Leading up to the end of August, I was looking forward to attending the HDA Traceability Seminar in Washington, DC.

News

EC to update IP rules to benefit generic exports

The European Commission (EC) is proposing to adjust intellectual property (IP) rules to help Europe's pharma companies tap into fast-growing global markets.

Views & Analysis

Submitting risk management plans on the new EU template: 3 t...

Are you prepared for the upcoming changeover to the new EU risk management plan (RMP) template? Seema Jaitly offers some timely guidance on the new EU RMP document.

News