Regulatory Affairs Compliance and Review
The management of science requires many converging forces that impact basic research, preclinical studies, clinical research and the broader development and operations of the research enterprise. Most graduate programs do not train bench scientists in these areas. However, many scientists transition into careers that allow them to take a central role in the oversight of science. The Regulatory Affairs, Compliance and Review Pathway holds three tracks that form the foundation of the management of science. All three tracks feed into positions found within all sectors of industry, various levels of government and academia. Dr. Joan Adamo, Associate Director, Regulatory Support Services and Assistant Professor of Biomedical Engineering, will coordinate this Pathway. Dr. Adamo currently manages University-wide Regulatory and Review issues, and teaches at the undergraduate and graduate levels. Prior to her position at UR, she spent five years in a Researcher / Regulator position in the Center for Biologics Evaluation and Research at the FDA.
Learn more about the Regulatory Affairs, Compliance and Review Pathway.
View activities that can help you explore this pathway.
Discuss ideas you have about gaining experience in Regulatory Affairs, Compliance and Review with Dr. Joan Adamo
Regulatory Affairs Track
As scientists move from academic training to an industry or a government research setting, bench research may still be a component, but layered upon this is the need to understand Regulatory Affairs that deal with current regulations that govern development, manufacturing and testing. Current regulations cover a wide swath of work from preclinical studies, clinical trials, product testing and data analysis all the way through labeling, marketing and distribution of regulated product. While US FDA or US Environmental Protection Agency (EPA) regulations would be most applicable to students moving through a biomedical or scientific training program, regulations flow from other sources such as Health Canada and the European Medicines Agency. Student collaborations with the appropriate subject matter experts will be available through university faculty and staff as well as university-associated assets such as regulated preclinical and clinical testing labs. Students who participate in this program will be prepared for private sector Regulatory Affairs positions in the pharmaceutical and medical device industry (and also in the food and nutritional supplement industry) that support adherence to these regulations.
Translational research brings research scientists closer to more highly-regulated fields. However, the jump from academic bench research to work in a regulated arena requires significant training and education. This program will provide students with the knowledge and practical skills to effectively support organizations performing Good Laboratory Practice (GLP)-compliant preclinical safety and toxicology studies, where controlled processes that ensure the validity and integrity of the data are mandatory. As translational investigators develop therapeutics and medical device innovations, an understanding of the ethical underpinnings and fundamentals, along with practical requirements, of Good Clinical Practices (GCP) will be presented. The UR GMP facility has a quality system, is capable of producing stem cell-derived products, monoclonal antibodies and other materials for the purpose of pre-clinical and clinical trials and will provide a vibrant and hands-on environment for URBEST trainees to learn the fundamentals of compliance. The basis for compliance with any of these highly regulated fields is the ability to write, understand and follow Standard Operating Procedures (SOP). In addition to mastery of SOPs, the validation of processes and equipment used in a GMP facility will be a key component in this track.
Programs, projects and grant proposals all require careful review by individuals who have a scientific background that enables them to make informed decisions about the potential success of each application. Whether the application is at the University review level or being evaluated for funding by a federal program, knowledge of core competencies is required for a successful review. Administration of funding programs requires a skill set beyond the solid foundation of writing and reviewing grants applications. It includes the ability to ascertain and clearly communicate pertinent information such as the merit of the project, potential risks and fit within the agency’s overall plans. Within this program, mastering skills such as writing study protocols, preparing applications and the ability to parse critical information must be developed concurrent with scientific expertise to enable scientists to hone their review skills.
Explore the Regulatory Affairs, Compliance, and Review Pathway
Shadow a Quality Assurance (QA) person at the University for a few hours.
Come up with an idea for the next America’s Got Regulatory Science Talent Student CompetitionYou've got plenty of time to put something together to wow the FDA in 2016. You might even want to track down the 2015 contest winner Angela Ryck to brainstorm your strategy.
Attend one or more of the lectures presented at the CTSI Seminar Series Advancing Regulatory Science and Translational Science
Take an online training course for how to submit an Investigational New Drug (IND) application to the FDA. Contact Dr. Joan Adamo to enroll.
Work with Dr. Joan Adamo to help develop or test drive a few Training Modules to Enhance Data Reproducibility
Attend a course on the topic – or even a lecture or two.
(Fall) BME431 FDA & Intellectual Property: Introduction to FDA Processes and Intellectual Property (IP) Considerations for Medical Products, Instructor: Joan Adamo, PhD (two credits) This interactive course will offer students exposure to the Lean Commercialization Approach, to intellectual property (IP), and Regulatory pathways for new medical innovations. Students will learn the terminology, processes and challenges involved in FDA regulations, Lean Commercialization, and the protection of intellectual property for medical innovations. Differences between Regulatory Affairs and Regulatory Science will be highlighted with opportunities to work on Regulatory Science in a project setting. An emphasis will be placed on the ways that knowledge of prior art and regulatory barriers can optimize concept selection, and early phase project planning to best identify projects suitable for commercialization. Instruction will include lectures, case studies, guest speakers and integrated assignments that will ask students to explore examples of commercialization, IP, and regulatory challenges, successes and failures. Lectures on regulatory and commercialization topics will alternate in order to allow students to understand the difficulty presented by balancing these challenges in the innovation process. Some assignments may be tailored to individual students’ research, design or work concentration areas and may be reviewed by the course instructors as well as consultants directly familiar with the process. Students will also have the opportunity to participate in the America’s Got Regulatory Science Talent Student Competition near the end of the semester.
(Spring) BME432 FDA & IP Commercialization: Implementing FDA Requirements and Practical Steps to Commercializing Medical Products, Instructor: Joan Adamo (two credits) This interactive course focuses on commercialization and FDA regulatory pathways for new medical innovations. Emphasis will be placed on the ways that knowledge of IP protection and regulatory barriers can optimize design, testing and commercialization strategies. Building on the basics learned in BME431, students will learn about the processes (and barriers) to bringing a product such as a novel medical device or novel or repurposed drug through clinical trials. Instruction will include lectures, case studies, guest speakers and integrated assignments that will ask students to explore examples of IP and regulatory challenges, successes and failures. Lectures on regulatory and commercialization topics will alternate in order to allow students to understand the difficulty presented by balancing these two challenges in the innovation process. Some assignments may be tailored to individual students’ research, design or work concentration areas and may be reviewed by the course instructors as well as consultants directly familiar with the process.