Frequently Asked Questions

What is ITMAT? 
The Institute for Translational Medicine and Therapeutics (ITMAT) supports research at the interface of basic and clinical research focusing on developing new and safer therapeutics. ITMAT offers research cores, research programs, research centers, and educational programs in clinical and translational science for researchers and research support staff. These are designed to facilitate training and research particularly from proof of concept in cellular and animal model systems across the translational divide to proof of concept and dose selection in humans. Become a member and utilize ITMAT resources and learn more about ITMAT.

What is ITMAT Education? 

ITMAT Education is the portfolio of education programs offered by ITMAT. We are committed to ensuring the delivery of high-quality programs in clinical and translational science for researchers and research support staff, and building a rigorous, resilient, inclusive and diverse CTS workforce.  ITMAT Ed offers educational programs at the undergraduate, predoctoral, postdoctoral, and staff levels, and offers many symposia, seminars, and various workshops focusing on emerging topics in translational research. 

The ITMAT Educational Programs are directed by Emma Meagher, MD. To view the list of ITMAT Ed Faculty and Administrative Leadership click here.

What is Translational Research? 
Translational research seeks to produce more meaningful, applicable results that directly benefit human health. The goal of translational research is to translate basic science discoveries more quickly and efficiently into clinical practice.  

What is Regulatory Science? 

There is increasing global demand for trained scientists who work in Academia, Biotech, Pharma, the FDA, and similar global regulatory agencies who are adept at applying knowledge of scientific and regulatory strategy to the design and execution of research portfolios focused on all stages of product (drug, biologic, and device) development. 

The Master of Science in Regulatory Science is designed to provide training in scientific and regulatory strategy to those who aim to pursue careers working on product development in Academia, Biotech, Pharma, the FDA and equivalent global regulatory agencies.

What is Regulatory Affairs?

Regulatory affairs professionals play key roles in bringing innovative products to market while also ensuring that products are safe and effective. Regulatory professionals work to maximize compliance, assure quality, and minimize risk in the development of FDA-regulated products (drugs, devices, and biologics) apply science-based clinical investigation and corresponding regulations. 

What’s required in the application and how do I apply? 

Applications are submitted online via CollegeNet.  Each program has an application page with instructions for how to create a CollegeNet Account and select your program, as well as the required documentation and instructions for personal statements and guidelines for letters of recommendation. 

MSTR Application Information

MSRS Application Information  

MRA Application Information 

When do I apply? 

For MSTR and MSRS: The annual request for applications (RFA) is announced in early September and due mid-October each year. The deadline is posted on the program webpage here. 

For MRA: Applications for fall matriculation are due May 1st of each year. 

Am I eligible for the MSTR or MSRS programs? 

Eligibility for the MSTR is detailed on the program webpage.
Eligibility for the MSRS program is detailed on the program webpage.
Eligibility for the Certificate program is detailed on the program webpage.

If you are also applying for ITMAT funding to complete an education program, reference the funding eligibility overview. Only one application is required to be considered for the education programs and funding awards.

I’m external to Penn/CHOP, am I eligible to apply? 

If you are external to the institution, you will need to identify a Penn or CHOP mentor in order to be eligible for the program. In addition, you must also meet the other eligibility criteria for the program.

Do I need to have research experience to apply to the program?  

We expect applicants to have a deep understanding of their research topic, but the program is designed to provide you with research knowledge, skills, methods, and tools needed to carry out your project. You need to be committed to your proposed project and identify a primary mentor with the interest and ability to guide you and your project. 

What does 80% protected time mean? 

For postdoctoral and faculty scholars, you must have 80% of your effort dedicated and funded for research. You may utilize the remaining 20% for clinical time, teaching, or other efforts.  

How do I know which program and/or funding mechanism is right for me? 

The MSTR and MSRS programs are primarily attractive to individuals seeking training in T1 translational research such as testing basic research findings for clinical effect (i.e. preclinical, first in human, proof of concept, phase 0/1 clinical trials) and research focused on the elucidation of mechanistic and therapeutic aspects of disease processes. The degree attracts students from all basic science and clinical disciplines. 

Students can choose to concentrate in a specific area of translational science. Concentrations include Discovery Science, which is intended for students interested in pathophysiological disease processes. Projects may be proof of concept in cell or animal models or using human samples; Translational Therapeutics and Regulatory Science, for students focusing on testing therapeutic discoveries for efficacy and safety; Entrepreneurial Science, offers students the opportunity to translate their research into innovative solutions and develop approaches to commercialization; and Bioinformatics/Biomedical Informatics, for students who wish to become translational scientists who can leverage informatics approaches to develop and test their own hypotheses as collaborators with informaticians.

When should I apply?

Predocs  

MD-MSTR: Applications are due in the fall of year 3 of the MD program.  

DMD-MSTR: Applications are due in the fall of year 2 of the DMD program and follow the dental dual-degree application process. 

PhD Certificate Applications are accepted on a rolling basis. 

Predocs are not eligible for the MSRS program.

Postdocs 

The timing of when you should enroll in the program is based on your career trajectory. Our learning community includes students who are junior faculty members, clinical fellows, postdoctoral fellows, residents, and predoctoral combined degree students. Notably, the students have reported benefiting from the intermingling of predocs, postdocs, and faculty in the same learning environment.  

Contact us to talk about your career and how our educational programs would benefit you.

Do I need to submit a separate application to be considered for ITMAT funding? 

No. If you submit your application during the annual request for applications, you will be automatically considered for both the education program and ITMAT funding opportunities.  

Which concentration do I select in the application? 

Select a concentration based on your career trajectory and research project area. This decision informs your plan of study and mentorship structure. You may change your concentration during the program.  

The MSRS program does not include concentrations, no concentration will need to be selected at the time of application.

Is your project a good fit for the program? Or do you have a few different projects and/or mentors in mind? We encourage you to reach out to get feedback on your project and mentorship team.

For the MSTR, review the concentrations to determine if your project would be best served by the MSTR curriculum and program. For the MSRS, review the program information and thesis project examples to determine if your project would be best served by the MSRS curriculum and program.

There are additional master’s degrees in the Perelman School of Medicine which are also available to you.

Reach out to Megan Maxwell to discuss your project, mentor, or any other aspect of the program. 

What if my project changes? 

The program anticipates that your project may change. The first course, Proposal Development, guides you through refining your project. An important part of translational research is to maintain focus, but it is rarely a straight line. When developing your project proposal for application, it is important to acknowledge the hurdles you may face and potential solutions.  

How do students pay for the program? 

ITMAT provides funding opportunities through the CTSA KL2 Career Development Award, the CTSA TL1 Training Grant, and ITMAT Scholarships. Students are also funded by T32 training grants, departmental funds, or faculty tuition benefits. To learn more about funding opportunities for the program, contact Megan Maxwell.

How are research supplies paid for? 

Costs associated with your research project may be paid for by your mentor’s lab or a research grant.  

Am I eligible for the MRA or certificate in RA programs? 

Eligibility for the MRA is detailed on the program webpage.
Eligibility for the RA Certificate program is detailed on the program webpage.

Regulatory Affairs programs are designed for working professionals currently employed in the field of regulatory affairs and clinical research. Candidates should have work experience related to regulatory affairs. Strong writing skills are also required. English language proficiency (TOEFL or degree from an English-language institution) is required as well.

Can I start in a semester other than fall?

The MRA program operates on a cohort-based model. Additionally, some courses required in the first semester are only taught during the fall. Applicants should plan to apply by May 1 for fall matriculation each year. 

That noted, learners are occasionally (as space allows) permitted to take REG courses as non-degree students, and these courses can be retroactively applied to the MRA or certificate program if they are part of the approved list of courses and the scholar later completes the application and receives admission to the MRA or certificate program. Scholars interested in taking regulatory courses as non-degree students should submit a permit request in Path@Penn (if they have taken other classes at Penn before) or the ITMAT course request form (if they have never taken classes at Penn). 

The MRA is designed to take 2 years, or 5 semesters (includes 1 summer semester). Students are able to take leaves of absence when necessary as long as the full program is completed within 5 years.

The Certificate in Regulatory Affairs is designed to take 1 year, or 4 semesters. Students can also take leaves of absence.

Synchronous class meetings are usually weekday evenings, Mon-Thurs, with start times between 4 and 6 p.m. Eastern time. Classes have a maximum 3 hours of meeting time per week, but many meet for shorter periods of time and supplement with at-your-own-pace work. Students are expected to be able to attend synchronous classes from a quiet, stationary, distraction-free space. All classes generally also include work and learning that must be completed at your own pace.

The Master of Regulatory Affairs has a fall cohort each year with an application deadline of May 1 for entry. The Certificate in Regulatory Affairs has both fall and spring cohorts; For fall entry, there is a May 1 deadline and for spring entry, there is an Oct 1 deadline.

As an online program, your required courses will be completed online. Our courses have a combination of synchronous components (Zoom class meetings) and asynchronous work (recorded lectures/readings, activities, projects). Online academic programs require a high level of autonomy and ability to manage your time. They also require some basic technical and digital skills to navigate the tools that we use, such as Canvas Learning Management System and Zoom, to deliver the course. It also means you can have classmates and instructors from all over the U.S. and the world!

Some electives may be offered in-person, but it is entirely possible to take all required classes in an online format.

Synchronous classes include some lecturing, but they also usually include class discussion, interactive work, group work, student presentations or other components that are important to participate in live. Course directors set the attendance policy in their classes, but in general, students can miss 1-2 live classes without penalty, and may be allowed (at faculty discretion) to complete makeup work if extenuating circumstances; however, students who cannot regularly make course meetings and devote their full attention during synchronous courses are not a good fit for the program.

All classes that students might take in the Certificate in Regulatory Affairs also apply to the Master of Regulatory Affairs. See the MRA curriculum page and the Certificate curriculum for more information.

Some capstone titles from the past several years include:

• Creation, Implementation, and Evaluation via Compliance Parameters of a Continuing Drug Manufacturing Compliance Education Program within the Penn Cyclotron Facility
• Risk-based Monitoring of Gene Therapy Clinical Trials for Hereditary Retinal Degeneration
• Trends in Reporting to the FDA Adverse Events Reporting System (FAERS)
• Longitudinal Study to Assess Long Term Comorbidities in Women with PCOS-Longitudinal PCOS
• Exploration of How Social Media Data is Used in Post-marketing Pregnancy Drug Safety Research
• Quality Management Systems at an Academic Research Institution: Development and Implementation of a Pilot Quality Management System at the University of Pennsylvania
• Evaluating Timelines, Processes, and the Downstream Operational Activation Impacted by Differences in IRB Review Models

And many more!

MRA students are expected to have at least 1 year of relevant professional experience before enrolling in the program. For certificate students, the requirement is at least 6 months. However, many Regulatory Affairs students are well established in their careers with years or even decades of professional experience.

How do students pay for the program? 

The Master of Regulatory Affairs and Certificate in Regulatory Affairs are designed for part-time enrollment so that scholars can continue to work while taking classes. Scholars can use tuition benefits from their employers, including, in the case of Penn and CHOP employees, Penn tuition benefits. (Please consider the taxability of graduate tuition benefits also.) Please note that if your employer has a tuition benefit and is not Penn/CHOP, you will need to familiarize yourself with the benefit and its stipulations.

The Student Financial Services office can work with students to determine payment and financial aid details. However, the Regulatory Affairs Certificate will not qualify students for federal financial aid. 

At this time, Regulatory Affairs programs do not have available scholarship funding.

How do the certificate programs differ from the master's degrees?

The certificate programs require a smaller commitment than master's degrees. Certificate programs generally require the completion of four (4) courses or credit units, and a 1-year time commitment. The master's programs of ITMAT Education require the completion of ten (10) courses or credit units, and a 2-year time commitment, including a summer semester.

How do I apply to the certificate in TR, RS, or ES? And am I eligible?

Please view the Certificate Application Information webpage for details.

How do I apply to the certificate in RA?

Please view the Certificate Information webpage. 

How is the certificate in RA different from the certificates in RS, TR, and ES?

The certificate in regulatory affairs has a different curriculum than the certificates in regulatory science, translational research, and entrepreneurial science. The certificate in regulatory affairs does not require the completion of a research project, while the other certificates do require a research project. The certificates in regulatory science, translational research, and entrepreneurial science require applicants to be enrolled in a Penn PhD program or postdoctoral students, while the regulatory affairs certificate requires only a bachelor's degree and relevant experience. 

If I initially apply to the Certificate in Regulatory Affairs, can I later pursue the master's degree?

Yes. Scholars may receive admission to the certificate program and go on to complete the Master's in Regulatory Affairs. 

In some cases, candidates who apply for the MRA program will be invited to enroll in the certificate program first, and to later matriculate into the MRA upon completion of several courses as a certificate student. The certificate provides an entry point for scholars to build skills and competencies either with a lower time commitment than the MRA or as a preparation for the MRA. 

In each case, moving from the Certificate to the MRA will require a formal application, but current Certificate students can be granted a waived application fee.