All You Ever Wanted to Know about a CPMP Hearing — A DRA Professional's Guide into the Unknown

As pharmaceutical companies become more involved in the Committee on Proprietary Medicinal Products (CPMP) procedures in the European Community (EC), they may find it necessary to participate in one or more hearings on their products. The CPMP hearing on a product issue gives manufacturers the opportunity to address all the objections/concerns about a product from the 12 EC regulatory agencies in one forum. This paper describes in detail the CPMP hearing and the strategies to be employed for a successful hearing at the CPMP.