COMMUNICATIONS FOCUSED ON DATA
COMMUNICATIONS FOCUSED ON DATA
Comprehensive review of DRUG DEVELOPMENT PROCESS, including drug’s life cycle, from discovery through post-marketing studies. Addresses non-clinical and clinical phases, and provides easy-to-understand definitions for commonly used terms (with 25-question test).
Overview of key elements of SCIENTIFIC EXCHANGE based on several FDA guidance documents including responding to unsolicited requests for off-label information about prescription drugs and medical devices and distributing scientific and medical publications on unapproved new uses – recommended practices. Covers range of activities including definition of scientific exchange and safe harbor, general guidelines for compliant content, responding to unsolicited questions for off-label, and distribution of scientific and medical publications on unapproved new uses.
Overview of PUBLICATION PLANNING. Covers range of activities for drugs and medical devices, including SWOT and gap analyses, congress strategy and initiatives for abstracts, posters, and presentations, manuscript development, authorship guidelines, journal selection, and publication management post publication.
Overview of REFERENCING promotional materials for drugs and medical devices targeting consumers and healthcare professionals. Covers range of activities including reference types, reference selection, reference and promotional material annotating, reference citation guidelines, and guidelines for referencing material based on audience.