A Regulatory professional’s role in the life-science industry demands a special adherence to a code of ethics.

  • Regulatory Compliance
  • Competency
  • Objectivity
  • Integrity
  • Honesty/Credibility
  • Accountability
  • Equitability
  • Dignity and Respect

Our employers, employees, peers, and all external parties with whom we interact, not only expect compliance with these ethical codes, but also rely on our competent guidance to support the life-cycle management of life-enhancing medicinal products. This reliance is based upon the knowledge that regulatory processes are developed and implemented with this aim in mind.

Reliability

the quality of being able to be trusted or believed because of working or behaving well

Regulatory reliability is critical in today’s evolving and demanding regulatory environment. As per the above, reliability is realised only when one is working or behaving well. A well-resourced, focused, and a highly regarded regulatory team with the proper executive leadership can be an effective way for an organisation to support “working well”. This team is fundamentally no different than any other risk averse discipline that requires targeted investment.

Unfortunately, without examining all causes, organisations often fault the regulatory professional when reliability suffers a decline. Facilitation of a forward-looking investment approach is de rigueur to achieve the highest level of regulatory reliability, essential for your organisation.

Please ensure that your regulatory teams are supplied with the correct tools and resources to execute their multiple responsibilities.

Safeguarding regulatory reliability will equal organisational success.

kimyoung@instem.com

K Young

References:

https://www.raps.org/who-we-are/advancing-the-profession/code-of-ethics

https://dictionary.cambridge.org/dictionary/english/reliability