Pharmaceutical Industry
Pharmacists bring insight into both clinical and operational areas within the pharmaceutical industry, from research and development to regulatory affairs and marketing. We typically group these roles into functional areas that hold different responsibilities to make the drug approval process more efficient. In the upcoming sections, we will be talking briefly about functional areas in the pharmaceutical industry and how each of them plays a role in the pipeline!
Clinical Development
Clinical development covers the process of discovery and testing of new chemical entities to formulate non-toxic and effective drugs. Scientists, project managers, and pharmacists all come together in designing and conducting clinical trials according to accepted scientific standards.
Today, pharmacists have become key players in clinical development for advice about drug structure, delivery methods, and pharmacokinetics-that is, the study of how a drug travels through the body. Additionally, they are called upon to construct clinical trial protocols, which are very detailed plans guiding trials to ensure safety and efficacy.
Medical Affairs
Medical Affairs is a unique area within the pharmaceutical industry that deals with communication among a pharmaceutical company, health professionals, and patients. In Medical Affairs, the job of the pharmacist involves sharing scientific information and clinical information with partners or stakeholders in various ways, including but not limited to presentations and educational pamphlets for health professionals and medical publications such as research articles and reviews.
In contrast to commercial affairs like marketing, medical affairs lead in translating data out of research into understandable, usable information by others within the company and external audiences. Medical affairs personnel are oriented not toward promoting or selling products, but toward ensuring that proper evidence-based communication of information occurs in support of safe and effective medication use.
Regulatory Affairs
Regulatory affairs is a crucial area within the pharmaceutical industry that focuses on ensuring that products are developed, marketed, and distributed in compliance with all relevant laws and regulations. Professionals in regulatory affairs play a key role in navigating the complex approval process, particularly by working closely with regulatory bodies such as the FDA (Food and Drug Administration) to ensure that new products meet the required standards for commercial use.
Regulatory pharmacists are involved in a variety of tasks, including:
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Staying current with laws and regulations that impact product approval and distribution
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Analyzing scientific data to ensure it meets regulatory requirements
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Advising teams in clinical development and medical affairs on how to align their work with FDA regulations and guidelines
Commercial & Marketing
Commercial sales & marketing focus on the sales and marketing of products. Pharmacists in this area collaborate with teams from medical and regulatory affairs to develop marketing strategies, create branding, and produce promotional materials. Their role involves ensuring that the marketing efforts are aligned with scientific and regulatory standards while effectively communicating the benefits of the products to healthcare professionals and patients.
Want To Learn More?
Read the Encapsulated Newsletter made by UTCOP IPhO members! In the newsletter, we talk about the various areas in the pharmaceutical industry and we interview professionals to answer your burning questions about the field. Get involved and get in contacted with our officers if you have more questions!