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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
Replay the moments of Euro Convergence 2020. Recorded sessions are available to attendees until 31 January 2020.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
As the international leader for the healthcare regulatory profession, RAPS has initiated and supported the development of this code of ethics for the profession. The principles embodied by these core values are outlined in the section (below) entitled “Fundamental Principles.” Following that, each core value is presented with suggested behaviors that should be encouraged or discouraged.
RAPS believes that this is a living document and encourages your feedback. Use this code of conduct in your work and share it with your colleagues and employer.
Regulatory professionals have the professional and ethical responsibility to maintain the highest standards of professional conduct as they exercise their professional duties of upholding and clarifying the laws and regulations of the authorities under which we operate.
As individual regulatory professionals, we are making a positive contribution to public health and we aspire to embody this code of ethics in our words, actions and deeds.
As regulatory professionals, we play a pivotal role in ensuring compliance with applicable laws and regulations in the development and commercialization of healthcare products. We are a diverse profession: we work in healthcare companies, for government regulatory agencies, for contract research organizations and as independent consultants around the world. Our profession includes attorneys, engineers, managers, nurses, pharmacists, physicians and scientists, among others. We are a growing profession and we are developing and continually exploring our core values in an increasing complex global regulatory environment. We do this in the hope that everyone who practices in this field will aspire to these principles. We do this also in the hope that those whom we serve will hold these principles as inviolable.
The following eight core values defined below are maintained from the original code:
As a regulatory professional I aspire to:
Our role as regulatory professionals is defined by our duty to advise individuals and organizations regarding the appropriate regulatory context for actions they may want to take.
Our role is further defined by our obligations as employees of companies making important medical products for patients, as members of teams conducting nonclinical and clinical studies, as regulators and as members of our profession.
Regulatory professionals have a duty to:
Competence means a regulatory professional has the knowledge, experience, ability and skill necessary to effectively identify, analyze and solve or recommend solutions to regulatory challenges. Regulatory professionals must be dedicated and flexible enough to adapt to the ever-changing realm of the regulatory profession.
The diversity of individuals and organizational contexts within the regulatory profession necessitates commitment to continually develop competence by a variety of means: seeking continuing education, work experience, professional training and certification.
Regulatory professionals develop competence by:
Regulatory professionals must be objective and must display their objectivity by representing facts without distortion by personal feelings or biases. The regulatory professional must understand the facts and must evaluate information from several points of view.
Regulatory professionals must understand their decisions may affect the interests of many parties including companies, regulators, healthcare professionals, patients and shareholders. Regulatory professionals must be aware of these differing interests without letting them influence their final regulatory interpretations and actions.
Regulatory professionals develop objectivity by:
Regulatory professionals with integrity will not compromise their values or trustworthiness for personal gain or professional enhancement. Individuals with integrity are principled, scrupulous and trustworthy. Having integrity suggests that one is “whole,” and one’s beliefs, words and actions are congruent and consistent.
Regulatory professionals develop and maintain integrity by:
Regulatory professionals must exhibit honesty in all of their activities. Honesty is truthfulness, candor and sincerity. Honesty requires a regulatory professional to act in ways free from deceit or deception, including dishonesty by omission or failing to say something when comment is ethically required. Honesty requires candid and forthcoming actions, not simply refraining from false statements.
Regulatory professionals build honesty and trust, which is essential to fostering effective working relationships, by:
Regulatory professionals demonstrate courage by choosing the right thing even when doing so is difficult. Regulatory professionals must have the courage to evaluate, conclude and provide consistent and accurate regulatory advice while accepting the consequences of their actions. They must gain access to information required to do their jobs as completely as possible.
Regulatory professionals develop courage by:
Regulatory professionals strive to treat all persons fairly, equitably and equally in accordance with the law by holding all those with common responsibilities to a common standard. Regulatory professionals should consider the rights and needs of all parties in the context of all applicable laws, regulations and scientific and societal norms.
Regulatory professionals demonstrate fairness by:
Regulatory professionals demonstrate respect by appreciating the worth or value of people and things. Regulatory professionals must respect the roles of their colleagues and should recognize and acknowledge the worth of all parties.
Regulatory professionals develop respect by: