Administrative Home: UCSF School of Pharmacy, Department of Bioengineering and Therapeutic Sciences
Article 1: Objective
1.1 Degree(s) offered by the program:
Master of Science: The degree diploma will be conferred with the designation “Master of Science in Regulatory Science and Digital Innovation.”
1.2 Discipline: A brief statement on the discipline(s) of the program.
The Regulatory Science and Digital Innovation (RSDI) program sits at the intersection of multiple advanced disciplines essential to addressing the dynamic challenges in modern regulatory science and healthcare innovation. Research and training within RSDI cover the regulatory science landscape from traditional frameworks to cutting-edge approaches in digital health, artificial intelligence, and medical technologies. The program builds a rigorous foundation in global regulatory practices, digital data governance, Software as a Medical Device (SaMD), and innovative regulatory strategies. These intersecting disciplines enable RSDI graduates to navigate the intricacies of international regulations and lead innovations in regulatory practices and policy to advance public health outcomes globally.
1.3 Mission of the Program:
The RSDI program aims to develop leaders with expertise in both regulatory science and innovation, equipping them to bridge the divide between scientific advancements, business strategies, and regulatory requirements. By fostering a global network of professionals dedicated to advancing healthcare outcomes, the program builds a collaborative environment for improving and transforming patient care worldwide. RSDI also trains professionals to assume leadership roles across industry and policy-making bodies, promoting impactful decision-making and innovative solutions. Additionally, the program seeks to modernize professional degree programs, such as PharmD, MD, and Dentistry, through certification and degree courses, equipping graduates with the latest skills in regulatory science to address the complex challenges of today’s healthcare landscape.
Article 2: Membership
2.1 Criteria for Membership in the Graduate Program
Authority to define criteria for faculty membership in the various graduate groups is delegated to the executive committees of these graduate groups, including criteria for inclusion, exclusion, and removal, unless otherwise specified. Further, authority is also delegated to graduate group executive committees to propose and administer Bylaws governing faculty participation and conduct. Membership is independent and separate from academic department appointments. Membership is based upon disciplinary expertise and active research, so members throughout campus are eligible for consideration to membership in the group.
The UCSF Graduate Group in Regulatory Science and Digital Innovation (RSDI Group) is composed of four subcommittees: 1) Executive Committee, 2) Admissions Committee, 3) Curriculum Committee, and 4) Capstone Committee.
2.2 Voting rights
Graduate program matters will be determined by a vote of the Executive Committee members. All members of the Executive Committee will have an equal vote.
2.3 Application for membership
How faculty may apply: To become a member of the RSDI Group, all interested faculty must formally apply to the program by submitting to the Executive Committee a curriculum vitae and a letter stating the reasons and qualifications of the faculty member for membership in the RSDI Group. Faculty members can also be nominated for membership by the Executive Committee. Following a vote by the Executive Committee, members shall be appointed for membership in the RSDI Group. The Executive Committee can make appointments with a simple majority vote.
2.4 Anticipated contributions that graduate faculty members will perform as a member
Faculty in the RSDI program are expected to demonstrate their commitment to the training program by regularly participating in program activities. These may include teaching in courses; serving as an Academic Advisor; outreach and other program activities; participating in recruitment and interviews; regular attendance at program events; and RSDI program committee service.
Mentoring and teaching in the lab/classroom: Program faculty are expected to maintain a productive and inclusive training environment for program students. Relevant measures may include evidence that the classroom environment is welcoming to and supportive of trainees from all backgrounds; that students produce rigorous and publication-worthy Capstone products; that research is conducted in the spirit of open science, when appropriate; that students complete their degrees in a timely manner; and that students successfully transition into careers in the scientific workforce.
Participation in faculty mentor development activities: Program faculty must take part in at least one mentorship development activity of their choosing each successive year. Typically, an “activity” will be a University-sponsored training, such as the courses offered by the Graduate Education and Postdoctoral Affairs (GEPA) (mentoring.ucsf.edu/trainings). However, the development of strong mentorship skills is an ongoing process that extends beyond any single course, and faculty are encouraged to seek mentorship development opportunities in many ways. Faculty who undertake significant activities outside of the University-sponsored training may petition the program to allow these activities to satisfy the mentor development activity requirement each year.
Compliance with University policies and Program values: Program faculty are expected to comply with all university policies and uphold the values of the training program, including but not limited to the University Code of Conduct (APM-016); UC Policy on Sexual Violence and Sexual Harassment; the UC Policy on Discrimination, and the Harassment, and Affirmative Action in the Workplace; scientific misconduct and/or financial improprieties.
2.5 Emeritus Status
Emeritus faculty with active research programs may remain members of the program and are afforded the following rights: they may attend and participate in program activities (including meetings and administrative committees), may teach graduate courses, and may serve on student committees. Emeritus faculty on the Executive Committee may vote on policy and bylaw issues related to the program.
2.6 Review of Membership
Membership renewal for non-Executive Committee members will occur every two years using the following process for all members eligible for term renewal: 1) the Executive Committee will consider contributions in teaching, student mentoring and advising and service, as well as documented research contributions in the area of Regulatory Science and Digital Innovation; 2) based on this evaluation, the Executive Committee will propose a slate of potential members to the RSDI Group; 3) following a vote by the entire RSDI group, members shall be re-appointed by the Executive Committee. A majority shall suffice for re-appointment. This process shall also serve as the mechanism for removing inactive members; members found to not be meeting required contributions in role responsibilities will be noted during review by the Executive Committee, notified, and not proposed on the slate for reappointment.
2.7 Obtaining relevant information
To ensure compliance with these requirements, the Program Director(s) and Executive Committee need to have the relevant information about faculty conduct. While information about faculty participation in program events and training is readily attainable, information about other types of violations may be difficult to obtain if, for example, the University is not forthcoming with information about faculty violations of University policies, or an individual who experiences a hostile interaction in the workplace does not report it. Thus, considering the different types and sources of information that are needed, the RSDI program proactively seeks to track compliance with these requirements in multiple ways, as described in section 2.8 below.
2.8 Violations of program expectations for faculty conduct
The Graduate Program Directors, Executive Committee, and Program Coordinators are in frequent communication with trainees, faculty, the Graduate Education and Postdoctoral Affairs (GEPA), and the University administration to monitor for compliance with all membership policy requirements. This can include reports from the Graduate Education and Postdoctoral Affairs (GEPA) and communications from the University administration about faculty violations of the University Code of Conduct. The Executive Committee will promptly revoke program membership at any time upon learning about faculty conduct detrimental to the program or the safety and welfare of its members. Examples of evidence of this type of detrimental conduct include (but are not limited to), official findings by the University that a faculty member has violated Title VII or IX, or legal determinations of guilt (including settlements out of court) that may not have resulted in a University sanction.
In addition, faculty may also be put on suspension or removed from the program for conduct that has not resulted in a University or legal sanction but nonetheless has been determined by the Executive Committee to be detrimental to the program or the safety and welfare of its members. This may include serious or sustained actions that create a hostile work environment such as a pattern of racist, sexist, or homophobic remarks or behavior, or a significant lack of professionalism or integrity. Indeed, the RSDI program expects all its faculty members to represent and uphold UCSF values of Professionalism, Respect, Integrity, Diversity and Excellence.
The Executive Committee will develop a course of action on a case-by-case basis. For example, faculty who are found to have violated Title VII or IX will be removed from the program immediately and are generally not eligible to reapply whereas the plan of action to address less severe violations may include interventions by program leadership, mediation, additional training, etc. before a decision to suspend or remove a faculty member from the program is reached. In any of these cases, the program may seek guidance from University offices and resources, such as the Office of Academic Affairs, the Office of the Ombuds, and the Graduate Education and Postdoctoral Affairs (GEPA).
2.9 Membership Appeal Process
If membership is denied or not renewed, faculty can appeal to the Executive Committee for reconsideration.
Article 3: Administration
The administrative leadership of the RSDI Group shall be vested in an Executive Committee composed of members who must be members of the UCSF Academic Senate or adjunct faculty.
Article 4: Graduate Program Director
4.1 Director and Co-director appointment process
The graduate Program Director or co-directors will be nominated in consultation with the Executive Committee and approved by a 2/3 vote of the Executive Committee provided that a quorum is present.
4.2 Director and Co-director terms of service
The Director and Co-director commit to serving for at least two years unless extenuating circumstances call for a shorter term.
4.3 Duties of the Director
The Program Director will be a full-time UCSF employee dedicated to the RSDI program. The Program Director will be responsible for program operations and have administrative and oversight duties related to Student Financial Support, Budget (in consultation with the Office of Administration and Finance, Dean’s Office-School of Pharmacy), Program evaluation and accreditation, and other tasks.
4.4 Duties of the Co-Director
RSDI does not have a provision for a Co-Director position. However, the program will have a Program Administrator. The Program Administrator is responsible for supporting the Program Director and assists with developing procedures to ensure effective operation of the Program. Duties and responsibilities will include management of admissions process, coordination of course and class scheduling, faculty and student support, coordination of committees, correspondence and communications, student financial support, student materials, tracking course and instructor evaluations, and website development and maintenance.
Article 5: Committees
5.1 Executive Committee
The Executive Committee shall consist of seven members who must be members of the UCSF Academic Senate or adjunct faculty. The inaugural Executive Committee is composed of the Program Director, the Director of Postgraduate Education Programs, and the Dean of the School of Pharmacy. Initially, the Executive Committee members will serve a two-year term. Current committee members may be re-elected by members of the RSDI Group or reappointed by the Dean of the School of Pharmacy.
For election of faculty members for the Executive Committee (beyond the current inaugural appointments), the current Executive Committee members will assess who they would recommend and nominate candidates. Any member of the RSDI Group may also submit nominations directly to the Executive Committee for review and consideration. Elections shall be conducted by a vote of the Executive Committee.
Election of the Executive Committee is by electronic ballot and shall be completed by at least 3 weeks before the end of the spring quarter. The term of office will be two years following selection. Election results shall be announced to the membership by electronic mail. Newly elected members shall assume their duties on July 1st of each year.
Decisions of the Executive Committee will be passed by a majority vote of the whole committee or of those present when meeting virtually or in-person. Ties will be broken by the Program Director.
The principal duties of the Executive Committee are:
To review faculty membership for the UCSF Graduate Group in Regulatory Science and Digital Innovation(RSDI)
To oversee general RSDI Group membership and reappointment, as described in Article 2.3
To review existing affiliations and explore new partnerships with other graduate programs
To appoint the standing committees described in Article 5 below, including Chairs of these committees, and other ad hoc committees as needed
To review and act on the recommendations of the Admissions Committee as appropriate
To outreach to other academic institutions, government, and industry for student funding, collaborative projects, internships, and career placement
To lead review of and suggest updates to the Bylaws as needed.
To conduct administrative and clerical matters related to the activities of the RSDI Group
To solicit feedback from matriculated students and from faculty, particularly those identifying with underrepresented groups and communities using both online anonymous surveys and focus groups
To conduct Town Hall meetings, at which the results of both surveys and focus groups will be presented and discussed and feedback on means to improvement will be actively solicited
The Executive Committee shall meet at least once every quarter to discharge their duties with respect to the UCSF Graduate Group in Regulatory Science and Digital Innovation. A calendar of events and meetings will be established at the beginning of each academic year.
5.2 Admissions Committee
Prospective students will fill out one application at UCSF which will be reviewed by the RSDI Admissions Committee. The Admissions Committee shall consist of at least 4 members serving
renewable 2-year terms, appointed by the Executive Committee. After the inaugural class of the program, the committee shall include one non-voting student representative, selected through an annual application process to the Admissions Committee. The Admissions Committee will review student applications and vote to select the successful student representative.
The committee shall meet twice-yearly and as needed, with responsibilities as follows:
To review, and recommend for approval, graduate student applications to the MS program
To review student admissions requirements and make appropriate modifications
To collaborate in the recruitment of graduate students
To review recruitment practices, admissions outcomes, and climate survey and focus group feedback. Formal benchmarks will include absolute numbers and proportions of student applicants, accepted students, and matriculated students, who identify as members of marginalized or under-represented groups
To make recommendations regarding recruitment strategies that will result in successful recruitment of a high quality, diverse student population
5.3 Curriculum Committee
The Curriculum Committee will comprise 5 members serving renewable 2-year terms. The committee shall meet twice-yearly and as needed, with responsibilities as follows:
To review course requirements for the program and make appropriate additions and deletions to the list of relevant courses
To develop recommended areas of specialization
To manage resources related to space, computing, and student funding, and identify new needs and opportunities in this regard
To actively solicit student feedback
To propose guidelines for student support including advising and mentoring
To identify and evaluate new Instructional Faculty
To review integration of training on health equity, systemic racism, ethics, and health disparities in the curriculum
5.4 Capstone Committee
The Capstone Committee shall consist of at least 4 members serving renewable 2-year terms. The committee shall meet twice-yearly and as needed, with responsibilities as follows:
To review Capstone Project requirements and make appropriate modifications
To develop recommended areas of specialization
To actively solicit student feedback
To propose guidelines for student support including advising and mentoring
To identify and evaluate new instructional faculty
To work in tandem with the Curriculum Committee on reviewing the academic requirements for the program
To work in tandem with the Curriculum Committee to develop the Capstone Project
5.5 Additional Ad Hoc Committees
In addition to these three standing committees, ad hoc committees may be appointed, as needed,
by the Executive Committee, e.g., committee for the development of a long-term strategic plan.
Article 6: Student Representatives
Student representatives are self-nominated or nominated by the students, typically in response to a Committee Service Announcement sent out by email. The nominees submit a short description of their interest in the position and particular qualifications, if applicable. The Program Director or Committee Chair will select the student representative from the list of nominees. The term of service and voting rights of the student representative will be determined by the Chair of the committee.
Article 7: Academic Advisors
The Regulatory Science and Digital Innovation (RSDI) Master’s Degree program students will be assigned an Academic Advisor upon enrollment in the Program. The Academic Advisor will serve as the students’ first point of contact and play an important role in facilitating and supporting the students’ academic and professional pursuits throughout the program. The Academic Advisors will monitor the students’ progress and address any academic and administrative concerns that may arise. Students will be required to have in-person meetings with their Academic Advisor at least once each quarter. The purpose of these meetings is to discuss the student’s coursework and general academic progression.
Foundational students will be paired with Capstone Project Advisors, who will be identified in the third quarter of the program (Winter quarter of the students’ first year). Students will not be expected to have identified a Capstone Project Advisor at time of application.
Article 8: Meetings of the RSDI Members
The RSDI program will have one annual meeting with the Program Directors, Adjunct Faculty, Student Representative, and staff, at the Program Retreat in the Spring. The Executive Committee shall call a special meeting whenever requested by written notice from 5 or more members. Meetings shall be conducted in accordance with generally accepted procedures. At general meetings, 6 current members of the RSDI program shall constitute a quorum and shall be empowered to act on matters before the meeting, except for changes in these Bylaws. Minutes of each meeting shall be the responsibility of the Executive Committee, facilitated by the Program Director, and shall be distributed to the membership following the meeting.
Article 9: Quorum
All issues that require a vote must be:
Voted on by at least 50% of the Executive Committee Membership
On graduate program matters other than amendment/revision of Bylaws, passage requires a supporting vote by at least two-thirds supporting vote of the members voting.
On amendments and revision of Bylaws: passage requires a supporting vote by at least two thirds of the members voting.
Proposed changes shall be submitted to the membership of the RSDI program by electronic mail ballot or for vote at a meeting, provided that written notice of the proposed changes is submitted to the members at least one week prior to the date of the meeting. 10 days must be provided for expression of opinions about the proposal prior to the acceptance of votes; the program must allow 14 days for votes to be returned or before the "polls are closed."
Article 10: Amendments
Amendments to these Bylaws may be made in accordance with the program's quorum policy in Article 9. Program members may propose amendments by petition to the Program Director. The Program Director, or relevant program committee, may ask for revisions from the faculty who submitted proposed amendments before forwarding the revisions to the membership for review and voting. All amendments and revisions must be submitted to the Graduate Council for review and approval; changes in the Bylaws will become effective upon approval by the Graduate Council.
Article 11: Curriculum and Program Standards
11.1 Curriculum
The program curriculum will consist of newly developed foundational courses in Regulatory Science and Digital Innovation in combination with existing coursework of the various PhD programs in the Quantitative Biosciences Consortium. Details of the curriculum will be determined by the Curriculum Committee described in Article 5. Any changes in curriculum requirements must be reported to the Graduate Education and Postdoctoral Affairs (GEPA) for review and approval.
11.2 Capstone Project
All capstone projects must be independent and original research or work that implements knowledge, techniques, and methods from regulatory sciences to contribute new knowledge to the field. The Capstone Committee will establish the guidelines and requirements for approval of capstone projects. Foundational Track students will commence work on their project at the beginning of the fourth quarter. The two components of the Capstone Project, the written project report and the oral presentation, will be evaluated by the Curriculum Committee and the Capstone Project Advisor. The Capstone Project will be graded S/U (Satisfactory/Unsatisfactory).
11.3 Program Evaluation
The Regulatory Science and Digital Innovation (RSDI) program will be reviewed per UCSF’s School of Pharmacy and/or Graduate Education and Postdoctoral Affairs (GEPA) review procedures. The Graduate Council and the Graduate Education and Postdoctoral Affairs (GEPA) will conduct an Academic Program Review of the program every five years, as per the rules and regulations established by the Graduate Education and Postdoctoral Affairs (GEPA).
11.4 Degree program standards
Degree program standards shall be determined by the Executive, Curriculum, and Capstone Committees (Article 5). Any changes in curriculum requirements must be reported to the Graduate Education and Postdoctoral Affairs (GEPA) for review and approval.
Article 12: Financial and Space Commitments
The Dean of the School of Pharmacy has committed space and financial resources to support the UCSF Graduate Group in Regulatory Science and Digital Innovation.
12.1 Space provisions
The School of Pharmacy will provide administrative space and support for program faculty, and access to workspaces for students, as well as access to conference and meeting rooms for seminars at the UCSF Mission Bay and Parnassus campuses. The RSDI program will be based at Mission Bay, with dedicated workspace for program faculty and staff.
12.2 Student support
The Program will work with UCSF's Financial Aid Office to determine and confirm federal and institutional aid eligibility for enrolled Foundational Track students prior to program launch. The RSDI program is dedicated to supporting students from underrepresented groups and will pursue support from various sources including industry and foundations to assist with student funding.