Regulatory Agency Meetings

How To Get the Most Out of Your FDA Meetings presentation by Dr. Alberto Grignolo, Corporate Vice President and Head of Worldwide Drug Development Consulting, PAREXEL Consulting
Overcoming the Obstacles to Rare Drug Approval in Europe to gain EMEA Approval by Dr. Gerald Haase, MD and Osian Edwards of PAREXEL Consulting and Jean Vincent, former Head of Regulatory Affairs at Biocodex
Alberto Grignolo, Corporate Vice President and General Manager, PAREXEL Consulting authored From Proof of Concept to First-Cycle Approval: Reducing Drug Development Risk through Effective Meetings with FDA in May 2008, Vol. 3, No. 6 of the RPM Report