blog
How to Choose a Medical Writer?
A medical writer is an essential part of any project team involved in developing a product to market and beyond.…
blog
Medical Writers brace themselves for new EU regulations
Some of the current ‘hot topics’ discussed at the 46th European Medical Writers Association (EMWA) conference in Barcelona included the…
blog
Do I need to comply with Policy 70 ?
It remains the mission of all stakeholders to get high-quality medicines to patients as time- and cost-efficiently as possible. To…
publication
EU Cooperation on Health Technology Assessment and Beyond
An informative session at this year’s DIA meeting gave an overview of the European Commission’s proposal for mandatory centralization of…
publication
Evolution of the European Regulatory Framework for Innovation – Key Topics for the Future
DIA Europe 2019 was held this year in Vienna, Austria. Speakers included national regulators, together with representatives from health technology…
publication
An Advocate of Collaboration : Flora Giorgio Interview
Eric Wery, Vice President Market Access at VCLS conducted an Interview with Flora Georgio, Head of Sector HTA European Commission…
publication
Overcoming the Challenges of Establishing Expanded Access Programs in European Member States
Early access programs (EAP) provide unauthorized medicinal products prior to marketing authorization and commercial launch for life-threatening, chronically or seriously…
publication
Considerations for Developing EU Risk Management Plans
This article aims to share some key considerations when defining the strategy for the preparation of a risk management plan…
