Collaboration Across the Lifecycle of Treatment Development and Safe Use – Contributions from Stakeholders Early Development Later Development Regulatory approval Healthcare delivery Safety monitoring Health communication Patients Describe living with disease Describe being treated Describe needs, goals, and wants Co-create / review research plans Co-create / review information for patients Give input to include in dossiers Review dossiers Give input to regulators Learn about treatments Talk about treatments and goals with HCP Tell HCP / sponsor / regulator about side effects Co-create / review non-promotional information Co-create / contribute (to) good information guidance HCPs Talk with / listen to patients about their needs, goals, and wants Talk with patients about interest / eligibility for clinical trials Talk about standard treatment Give input on current treatment regimens Learn about safe and appropriate use of product Report side effects promptly Co-create / review / distribute non-promotional materials Sponsors Co-create / request patient review of research plans; incorporate needed changes Co-create / request patient review of information for patients; incorporate needed changes Include patient input in dossiers Propose patient-oriented labeling Monitor safety and effectiveness of treatments in patient-friendly ways Co-create non-promotional information per guidance Regulators Invite / attend public discussions of patients’ diseases, treatments, needs, goals, and wants Talk with sponsors and patients about development plans Co-create / provide guidance on including patients’ input in treatment development Include patient input in review of dossiers Co-create / provide guidance on including patients’ input in non-promotional information