publication
Incorporating patients’ voices in the drug development process
Our Senior Director, Mike Day recently interviewed Robyn Bent, Director, CDER PFDD Program, Center for Drug Evaluation and Research, US…
Case study
Emergency Response: Getting Ahead of The Competitors
A US based emerging biopharma recognized that one of their anti-viral therapeutics being developed for a different indication might also…
publication
Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs,…
The added value of in silico models (including quantitative systems pharmacology models) for drug development is now unanimously recognized. It…
webinar
Deep Dive into FDA’s Expedited Programs for Drug Development
If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by…
presentation
Deep Dive into FDA’s Expedited Programs for Drug Development
If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by…
webinar
Achieve Success for Your US Product Application
The introduction of a new medicinal product to the US market follows a complex process that may extend many years…
webinar
FDA Consideration for e-Health
Anastacia Bilek, Ph.D. will share her experience in the regulation of m-Health products as a guide for product developers. She will…
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…
