CLINICAL DEVELOPMENT STRATEGY

from CLINICAL TRANSLATION 

to REGULATORY APPROVAL

​

Therapeutic area strategy and portfolio, life cycle development planning.

 

Regulatory strategy for new investigational drugs to marketing authorisation applications. Presentation, interaction, and negotiation with drug regulatory agencies worldwide.

 

Clinical development programs from first in human, proof of concept to pivotal studies. 

 

Clinical trials design and operational implementation in clinical setting. Clinical trials data analysis, interpretation, reporting, and peer communication.

 

Ophthalmology therapeutic area, particular strength in retina drug development and retina imaging markers evaluation.