webinar
Opportunities for early dialogue with the EMA and HTA bodies. Optimizing product development to ensure…
Early engagement and scientific advice with European Medicines Agency (EMA) is a key driver to faster and more often, successful…
webinar
Efficient Drug Development for Promising Medicines: Comparative Introduction to EU & US Regulatory Tools
With a lack of adequate therapeutic options for the great number of patients living with serious diseases, both the EMA…
webinar
Preparing Clinical and Product Development Documentation for Public Release
The European Medicines Agency’s initiatives to increase the transparency of clinical trials, and provide an access to summary study results…
webinar
10 Things to Know Before Entering the European Market
Expanding product development to an overseas market can often be difficult to navigate. Thankfully we can help you to find…
webinar
Managing a Global Publishing Strategy
Having an electronic submission strategy in place is critical in supporting the transition to eCTD. Advanced planning and an understanding…
webinar
Initiating Clinical Trials in the EU: Current Scenario and Upcoming Changes
With 28 member states and associated countries, initiating a clinical trial in the EU is perceived by many in the…
blog
What should you know about the Trial Master File: a refresher
The Trial Master File refers to a repository of documents that collectively can be used by monitors, auditors, assessors and…
blog
Are you making the most of the incentives and benefits that are available to support…
The importance of SMEs is nicely captured in a quote by Jean-Claude Juncker, President of the European Commission: We must…
