Regulatory affairs can be defined as “the profession responsible for overseeing and providing direction for government-mandated regulations related to the safety and efficacy of products within pharmaceutical, biotech, medical device, veterinary, and healthcare industries.”
Professionals working in this area and in these industries rely on the guiding principles and requirements of regulatory authorities, such as the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH), to make certain that their employers are compliant.
Born out of the need to ensure that safe and effective products are delivered to the public via standardized methods, the FDA and ICH have built a framework of rules and regulations for a myriad of situations and industries with examples ranging from the ethical conduct of clinical trials to compliant labeling and advertising practices of pharmaceutical companies.
These professionals come from a wide variety of backgrounds and a recent report from the largest consortium for the industry, Regulatory Affairs Professional Society (RAPS), indicates that about 75 percent of professionals who transition into regulatory affairs do so from industries that are closely-related — those being research & development, laboratory sciences, engineering, clinical research, and pharmacy/pharmacology1.
Regulatory affairs is quickly becoming a popular field of work for many scientists who choose to leave bench-work, but would prefer not to leave the sciences entirely. It has a long-standing tradition of being a stable and well-paying career and provides an extensive amount of translatable and valuable skills.
For those of us wishing to expand our knowledge of the field and practices, there are several sources of information available online at:
The FDA’s Training and Continuing Education website categorizes material based on profession (such as student, clinical investigator, and educator) and center (such as CDER and CDRH).
The Center for Drug Evaluation and Research (CDER) is responsible for ensuring safe and effective prescription and over-the-counter drugs, whereas the Center for Devices and Radiological Health (CDRH) ensures safe and effective medical devices and radiation-emitting products 2,3.
On these sites, you will find links to training videos and guidance documents related to the more common regulations.
Over the next few weeks, readers will be provided with summaries of the information found on CDERLearn4. Topic 1 will outline the Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND and begins with a brief introduction of investigational new drug application (IND) and CMC basics and formal meetings between the FDA and sponsor ors applicant, and moves on to the CMC requirements for the IND.
Readers will then be introduced to topic 2, Bringing the Over-the-Counter OTC) Drug to Market, and topic 3, Medicines in My Home. The series will conclude with topic 4, Neglected Tropical Diseases of the Developing World.
The purpose of this series is to streamline and make readable the often verbose but necessary rules and regulations, which impact a number of related professions as well as consumers.
Please visit the pages below for more information related to RAPS, the FDA, or any of the cited training documentation:
Also, please be sure to perform a quick web search for professional societies in your area as they often meet and discuss pertinent information related to the regulated industries within your city or state.