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By Kim Huynh-Ba

KimHuynhbaThe process of getting a drug from the initial stage of development to the point where it is available on the market is a complex, expensive, and highly regulated one.  Drugs and other pharmaceutical products are stringently regulated to protect the consumer by ensuring the safety and efficacy of the product. Every year, the pharmaceutical industry spends billions of dollars to bring a drug to market. These pharmaceutical products are typically developed by private companies, but approval is required from government regulatory agencies to gain market access.

The world is a global marketplace. The development and manufacturing of drugs might take place in a different location than where it will be marketed, and it is important for there to be a set of rules that govern the drug development process regardless of the country of origin of the drug, thus ensuring harmonization. In most cases, regulations are set and enforced by government agencies that oversee the entire process of drug development and ensure that the pharmaceutical companies follow the law and do not cut corners. Needless to say, a thorough understanding of regulatory sciences pertaining to both domestic and international markets is vital to a pharmaceutical scientist. But as education is not always readily available, we continue to see a training gap in this field.

Therefore, to respond to the needs of its members and the pharmaceutical community, the AAPS Regulatory Sciences section has developed an online lecture series, AAPS Regulatory Affairs 101—Essentials of Regulatory Affairs for Pharmaceutical Scientists, for professionals looking to expand their regulatory knowledge or to enter this profession. The objective of this ecourse is to provide an overview as well as cross-functional training in the regulatory sciences from the perspective of a pharmaceutical scientist to better understand current regulatory processes from discovery to commercialization of pharmaceutical products. This series consists of 10 lectures covering 10 of the most critical areas of regulatory processes ranging from drug discovery to manufacturing. With the expansion of marketing products in emerging markets such as Brazil, Russia, India, and China, this course has also been designed to present a global outlook on regulatory affairs and how regulations impact the current development process.

Kim Huynh-Ba, M.S., P.M.P., is the executive director of Pharmalytik, which provides consulting and training services to pharmaceutical companies. She has nearly 25 years’ experience in analytical development, project management, strategic drug development, and stability sciences.