Training | Center of Excellence in Regulatory Science and Innovation

The primary educational mission of our CERSI is to expand the knowledge base of FDA staff and scientists and CERSI faculty about state-of-the-art tools and methods to support regulatory science.

Thus, our approach is a broad one, recognizing that training in regulatory science includes varied skill sets and covers extensive content areas ranging from clinical evaluations to improve product development and patient outcomes to new prevention-focused food safety systems to protect public health. Our training builds upon a rich environment supporting the highest caliber of scholarly investigation at Johns Hopkins, including an incredibly skilled and diverse faculty as well as extensive pool of trainees at all stages of professional development. In addition to onsite training at the FDA and courses, certificate programs, and degree offerings at Johns Hopkins, we will also leverage extensive capabilities for innovative online learning in order to develop self-sustaining regulatory science training that can be made available to FDA staff and scientists around the world.

2023 Writing Competition

We are pleased to announce the winners of the 2022 CERSI Writing Competition!

First place: Pavithra Peranamallur Thirumalai, "Computer Software Assurance - An Interpretation and Future"
Second place: Angela Yu, "Regulatory Intelligence as a Business Partner"
Third place: Marcus Taylor, "A Regulatory Perspective on Dose Optimization for Oncology Products"

Each year, we invite students to submit a manuscript on a regulatory science or food safety regulation topic of their choice. The call for submissions for the next competition will be disseminated in 2024.

Winners will receive a cash prize for first, second, and third place, respectively.

Entrants must be currently enrolled in the Masters of Science in Regulatory Science or Masters of Science in Food Safety Regulation at Johns Hopkins University.

For more information, please see the Official 2023 Writing Competition Guidelines.

Click here to view our winners from previous years.

CERSI Scholars

The CERSI Scholars program integrates our most outstanding students in the regulatory science arena into all of the activities of our Center by encouraging these students to participate in our research, and educational activities, and collaborative activities with other CERSIs and the FDA. The scholars are provided with small stipends to support their regulatory research activities. We currently have eight scholars who are doctoral students working in the fields of clinical trials, biostatistics, environmental health science, and computer science.

More information about our current and past scholars can be found here.

Please contact the Center at cersi@jhu.edu for information who how to apply to be a CERSI Scholar.

Workshops and Symposia

Advancing COVID-19 Regulatory Science Using Clinical Informatics: A Two-Part Webinar (May 2021)

This two-part webinar provided a stimulating and timely analysis of the use of clinical informatics in optimizing the regulatory and public health response to the COVID-19 pandemic in the United States. More information about the webinar is available here.

Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities (November 2018)

This symposium focused on strategies to improve assessment and communication of heterogeneity of treatment effect (HTE), or variations in how individuals respond to treatment, to stakeholders. More information about the symposium is available here.

Substitutability of Generic Drugs: Perceptions and Reality (November 2016)

This workshop explored post-market surveillance and research of generic products, providing timely communication to the public as well as identifying future research needs.

Clinical Trials: Assessing Safety and Efficacy for a Diverse Population (December 2015)

This workshop focused on evidence from clinical trials and other data sources to address potential heterogeneity of treatment effects across large and diverse populations. More information about the workshop is available here.

Certificates

The Clinical Trials Certificate focuses primarily on the design and analysis of randomized clinical trials for evaluation of licensed and non-licensed medical products and other health interventions, the regulatory framework for the conduct and evaluation of data from clinical trials, and ethical principles for the conduct of clinical trials.

The Pharmacoepidemiology and Drug Safety Certificate is designed for early and mid-career public health professionals who wish to expand their knowledge of pharmacoepidemiology and drug safety to inform their work in academic, regulatory, or industry settings.

The Risk Sciences and Public Policy Certificate Program provides multidisciplinary education designed to increase awareness of the scientific underpinnings of risk assessment and provide a bridge between science and policy that allows innovative public health solutions to complex problems.

Degrees

The department of Epidemiology offers master's and doctoral degrees in the following tracks pertaining to regulatory science:

The Cardiovascular Disease and Clinical Epidemiology Track focuses on the use of rigorous epidemiologic methods as applied to clinical and translational research, with emphasis on cardiovascular disease.
The Clinical Trials and Evidence Synthesis Track focuses on didactic and experiential learning about the design, conduct and analysis of randomized clinical trials and meta-analyses of clinical studies.
The Environmental Epidemiology Track examines the epidemiology of disease associated with industrial and other occupational exposures as well as environmentally induced illness in general populations.
The General Epidemiology and Methodology Track provides a solid foundational knowledge in epidemiologic and statistical methods and a clear understanding of general principles of the dynamics of health and disease in human populations.

The School of Public Health also offers many Master’s programs relevant to the field of regulatory science:

Master of Science in Regulatory Science at Johns Hopkins

The Johns Hopkins University Advanced Academic Programs offers a MS in Regulatory Science. The program places a broad focus on current good manufacturing, laboratory and clinical practices and product development to provide students with a solid background in the regulatory approval processes for global and domestic biotech products.

Applications are accepted year-round and students may enroll in Fall, Spring or Summer semesters.

To learn more, please visit the MS in Regulatory Science website.

Master of Science in Food Safety Regulation

The new Master of Science in Food Safety Regulation is designed to provide students with an understanding of the legal and regulatory complexities of food production, labeling, and distribution. The program will provide students with the knowledge required for companies and organizations that grow, process, distribute, or sell foods and beverages while complying with federal and state regulatory statutes for the production, distribution, and commercialization of food products.

To learn more, please visit the MS in Food Safety Regulation website.

Center for Biotechnology Education

The Johns Hopkins University Krieger School of Arts and Sciences Center for Biotechnology Education engages diverse audiences in the world of biotechnology and prepares the leaders of today, tomorrow, and the next generation for the challenges of the 21st century. The Center for Biotechnology Education is building a pipeline of students and professionals prepared to achieve success in K-12 education, graduate school, and the work environment in the fields of biotechnology, bioinformatics, regulatory science, and biotechnology enterprise and entrepreneurship.

To learn more, please visit the Center for Biotechnology Education website.

Service Fellowship Plan for FDA

The FDA Service Fellowship program offers an opportunity for temporary employment, training and professional development of promising research/regulatory scientists. The program offers participants the chance to work closely with leading authorities in health-related research and regulation.

To learn more, please visit the Service Fellowship's website.

FDA Training Resources

There are a number of FDA resources to learn about FDA and regulatory science. These include:

FDA staff also collaborate with the CERSI in other activities including: sponsorship of academic visits to the FDA; delivery of training activities such as workshops, courses or lectures; and promotion CERSI activities on FDA intranet websites such as the FDA Scientific Professional Development Calendar coordinated by FDA’s Office of Scientific Professional Development.