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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
As regulatory professionals, we have the responsibility to maintain particularly high standards of professional conduct while exercising professional requirements and duties in upholding and clarifying the applicable laws and regulations. We strive to make a positive contribution to public health by using this code of ethics in our workplace(s). This is the RAPS Code of Ethics; regulatory professionals understand that their employers and others may have other codes of ethics that they may need to acknowledge, understand, and follow.
Our Code of Ethics was first initiated in 2003 and has been updated twice since then. We vow to regularly assess its applicability and refresh its content as the regulatory profession grows and evolves.
As a regulatory professional I aspire to:
RAPS members perceive eight core values that regulatory professionals use in conducting their professional responsibilities.
Our role is defined by our responsibility to advise individuals, team members and organizations regarding the appropriate regulatory context for actions they may want to take. We also must heed our obligations as employees, consultants, and contractors for making products for patients; as members of teams conducting clinical & nonclinical studies; as regulators; and as members of our profession. Regulatory professionals have a duty to:
Competence means the regulatory professional has the knowledge, experience, ability, and skill sets to effectively identify, analyze, solve, or recommend solutions for regulatory challenges. We must be dedicated, yet flexible to adapt to the constantly changing requirements.
The diversity of individuals and organizations within the profession necessitates a commitment to evolve by a variety of options: continuing education, work experience, professional training, and certifications.
Maintaining regulatory competence is a continual learning process. Regulatory professionals develop competence by:
Regulatory professionals display objectivity by:
Regulatory professionals should not compromise their values or trustworthiness for personal gain or professional enhancement. Regulatory professionals shall develop and maintain integrity by:
Regulatory professionals shall exhibit honesty in all activities. Honesty requires acting free from deceit or deception, including dishonesty by omission or failing to provide comment when ethically required. Regulatory professionals shall build honesty and trust by:
Regulatory professionals must have courage to evaluate, conclude, and provide consistent and accurate advice. Regulatory professionals develop courage by:
Regulatory professionals strive to treat all persons fairly, equitably, and equally to create and maintain a healthy workplace, so that all people can thrive both personally and professionally. Regulatory professionals demonstrate fairness by:
Regulatory professionals must respect the roles of their colleagues, and both recognize and acknowledge all. Regulatory professionals develop respect by:
Effective September 2022