Who needs to participate in the REMS process?
Maybe the question should be “who doesn’t?” REMS development is perhaps second only to drug development and commercialization as a true multi-disciplinary effort. Expertise is needed from clinical, regulatory, legal, biostatistics, and marketing experts, while the documentation and preparations require drug safety, risk management, document writing, medical education, marketing research, graphics design, project management, and training staff. The creation of a multi-disciplinary REMS Implementation Team is strongly advised which, together with project management, project coordination, and subject matter expertise, can help assure that nothing falls through the cracks, vendors are being coordinated, and the program is ready at product launch.
