Safety data collection, integrated analyses, and intelligent data mining toward the development of a rigorous and validated Integrated Safety Summary (ISS).

New product launch strategies as a component of the drug’s development plan and risk management strategy.

Design of efficient Phase III - IV development schemes to

Guide and assist in the development of the PDUFA-3 risk management proposals and pharmacovigilance plans including representation with the compnay at FDA meetings

Drug abuse liability assessments for initial or subsequent national and international drug scheduling.