Overview
Success in meeting regulatory challenges requires a greater appreciation for the regulatory policy-making process in an area strongly informed by science, inevitably characterized by uncertainty, and often subject to high levels of political and financial interest. This course is designed to help decision-makers at FDA, and more broadly at HHS and other public health organizations, better understand the policy-making process and apply that understanding in their own work .

Program Content
Learning Objectives:
This course is designed to enable staff from the scientific, engineering, legal, risk management and communication fields to benefit not only from the course content itself, but also from each other's experience and perspectives. Participants who have fully completed all elements of the program will better understand:

• The dynamic environment surrounding FDA's, HHS's and other federal public health agencies' regulatory mission and programs.
• The reasons and need for regulatory policy.
• The key elements and characteristics of sound policy decision-making.
• Factors to be considered in developing sound policies.
• Factors to be considered in assessing policies.
• Factors to be considered in communicating policies, policy options, risks and decisions.
• Factors that place regulatory issues on HHS's or on an agency's agenda for action.
• Balancing policy development, science, risk and uncertainty.
• Post-regulation implementation issues and tools.
• The perspectives, roles, and responsibilities of key actors in the policy process.

Course Components:
The program addresses four key areas:

• The Context for Regulatory Policy: Explores the mission of the FDA, HHS, and other public health organizations' objectives, the characteristics of the regulated community whose actions public health agencies seek to influence and the arguments for and against government action in this policy area.
• The Policy-Making Process: Examines the role of science and other factors affecting decision-making process for the development of a specific regulation. Themes of risk assessment and uncertainty for science are also examined.
• Stakeholders and the Public: Discusses promulgation and post-promulgation aspects of information and participation, the importance of fairness in outreach, importance of involving the public in the regulatory process and what the public needs to know.
• Effective Implementation of Regulatory Programs: Assess the post-regulation implementation issues and the importance of implementing effective compliance programs. Emphasis is placed upon designing effective compliance programs and implementing a results-oriented focus.

Course Delivery:
The program is intended as a six-day course of study conducted over approximately three months. The program relies heavily on interactive forms of learning. Sessions include traditional academic formats, experiential exercises, small group interactions, and case studies.

Please contact the Office for information on upcoming dates, location, and cost.