Domains represent the major content categories within each level of the PD Framework. The four domains are organized to encompass major tasks and responsibilities of the regulatory professional throughout the product lifecycle.
The PD Framework domains are:
- Strategic planning: encompassing regulatory strategy throughout the lifecycle; access to and organization of regulatory information and knowledge; integration of regulatory perspectives into the organization; and regulatory policies and procedures. At Levels III and IV, this domain also includes integration of regulatory strategy and policy into overall organizational approaches. Responsibilities described under this domain apply throughout the lifecycle.
- Premarketing: encompassing research and development; and preclinical and clinical phases through submission/registration.
- Postmarketing: encompassing reporting; compliance; inspections; labeling; advertising, promotion and sales; postmarket surveillance; reimbursement and product obsolescence.
- Interfacing: responsibilities extending throughout the lifecycle, encompassing communication and interaction within the organization; with regulatory agencies, professional trade and standards organizations; and with other stakeholders.