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By: HaiAn Zheng

zheng-headshotIs regulatory sciences the same as regulatory affairs? When teaching students, training employees, or developing regulatory programs, we often use them interchangeably. They are similar and related, but should we distinguish these two terms with more depth? 

Firstly, what is regulatory sciences? AAPS is probably the earliest pharmaceutical organization to adopt this term by establishing the Regulatory Sciences section. The section was envisioned to be the “premier organization” on “development and realization of innovative, science-based regulatory solutions.” Then in 2010, the Food and Drug Administration (FDA) launched the Advancing Regulatory Science Initiative and published their official definition: “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.” This definition has been well accepted globally since then.

We may argue that every pharmaceutical scientist may “assess” and evaluate drug products, therefore participating in regulatory sciences by the FDA definition. The core content and knowledge base of pharmacy and pharmaceutical sciences includes: safety—a focus of toxicology; efficacy—a focus of pharmacology and medicinal chemistry; quality—a focus of pharmaceutics and engineering; and performance—the focus of pharmacokinetics, pharmacotherapy, and clinical sciences. These actually constituent the core components for Pharm.D. and graduate curriculums! Also, the recent regulatory science efforts of information integration and knowledge management are providing exciting and timely opportunities that can help curriculum updating, not only for pharmacy schools, but also for medical and other healthcare education programs.

Many students have showed interest in regulatory topics and careers, probably inspired by many alumni’s rewarding careers or headline news about FDA. Therefore, Albany College of Pharmacy and Health Sciences (ACPHS) has offered a Regulatory Sciences course since 2012, thanks to supports from FDA and industry colleagues who contributed guest lectures or hosted site visits. After the first offering, we are more confident that regulatory sciences is a better course name than regulatory affairs. While it is impossible to cover all regulations and FDA-regulated products within one course, we focused on applying basic and pharmaceutical sciences to selected policies, guidances, and cases. Also, scientific discussions are more universal and global, and less restricted by time, regional, political, economic, and cultural differences and changes.

Secondly, what is regulatory affairs? Should we differentiate it from regulatory sciences? Regulatory affairs is a profession of functions and actions. We use regulatory sciences to practice regulatory affairs, just like we use pharmaceutical sciences to provide the scientific foundation for the pharmacy practice. For example, the Biopharmaceutics Classification System (BSC) is a regulatory science approach based on clear principles, which have been adapted almost globally. But applying it to specific generic drug products for bioequivalent evaluation still need regulatory affairs efforts of discussions and decision-making.

When teaching regulatory sciences, guest lecturers that are regulatory affairs professionals were always welcomed by students. They brought valuable insights, real experiences, and practical examples to classroom. However, FDA or industrial guests could not promise their time every year. Therefore, we were glad to discover the AAPS eCourse Regulatory Affairs 101, which was a good addition to our course. These online lectures were organized and taught by a team of AAPS scientists from FDA, industry, and academia, who contributed their best knowledge and experiences. Although titled as Regulatory Affairs 101, the lectures balanced very well between regulatory sciences and regulatory affairs at a graduate school level.

Supported by ACPHS and our Instructional Design Team, we combined eLearning lectures with our own online active learning tools (blogs, wiki, and homework assignments), in-class lectures, and activities (projects of case studies, presentations, workshops, and debates) to optimize education outcomes. When learning regulatory sciences principles, students also learned more about regulatory affairs practices and careers, and they refined their soft skills, such as communication, presenting, negotiation, and project management, which are essential skills of regulatory affairs professionals.

Defining regulatory sciences and regulatory affairs more specifically can help us develop better training courses and education programs with clearer education goals. It can also help emphasize the importance of scientific education and research for regulation and policy making, as many challenges and opportunities exist. We are looking forward to more discussions during the AAPS Annual Meeting. (Poster 03W0300 on Wednesday November 16th)

(Author thanks Drs. Debra Feinberg and Judy Teng, and many other colleagues who contributed to this on-going team project.)

HaiAn Zheng, Ph.D., is an associate professor at Albany College of Pharmacy and Health Sciences, teaching Pharmaceutics and Regulatory Sciences. With many years of industrial and academic experience, his research focuses on complex drug products.