PhD - RAQA Concentration

PhD - RAQA Concentration

The RAQA graduate program of Temple University’s School of Pharmacy (TUSP) is well recognized as the most comprehensive and largest academic program of its kind. Since 1968, over 2,600 students have graduated with the MS in RAQA, the majority of whom work in the regulated industries of pharmaceuticals, medical devices, biopharmaceuticals, and related areas.

In 2018, Temple University School of Pharmacy established an RAQA PhD concentration within the Pharmaceutical Science doctoral program. This degree meets the needs of professionals working in regulated industry and various regulatory authorities, who have worked for decades in RA/QA and are highly accomplished experts seeking a doctoral degree to advance professionally.

The RAQA PhD concentration will also address FDA’s Advancing Regulatory Science Initiative, which promotes innovative ways to transform how regulated products are developed, evaluated, and manufactured. Emphasis in this new concentration will be placed on combining scientific principles and methodology with regulatory and quality practices to streamline the discovery, manufacturing, safety profiling, and post approval processes.

The intent of the PhD program is to apply academic research methods to current industry regulatory and quality issues, enabling candidates to address the problems with data research and scientific methodology. The goal of each thesis should be to present new and thoughtful answers to industry questions and problems that result in cost savings, safer and/or more effective products, better safety profiles, and other benefits for patients and manufacturers.
This highly selective and demanding PhD program does not require a residency and may be completed on a part-time basis; however, it is thesis-based and will take approximately 5 years to complete, depending upon the effort and available time of the candidate. The final thesis should consist of an appropriate mix of quantitative and qualitative research methodology and be suitable for publication.

Applications for this degree are being accepted for the Fall 2023 semester. After the Fall 2023 uptake, the next round of applications will be accepted for the Fall 2025 semester.
All expenses of the program are the responsibility of the selected candidates.

The PhD Thesis
The Doctor of Philosophy (PhD) is the highest academic, research-based degree that can be obtained. One of the important differences between a professional doctorate degree and a Doctor of Philosophy (PhD) is the pursuit of a thesis dissertation, which can be described as a unique and original question that is investigated through prolonged research and analysis. The dissertation is supervised and critiqued by a panel of experts and should ultimately result in a comprehensive, published work. The methodology for a PhD thesis should include both qualitative and quantitative analyses over a period of several years. In many cases, original source documents will be used. Importantly, the development of the thesis takes place over time and must include more than Internet and/or library searches. The candidate must be able to formulate original and innovative thought, pursue logical and thorough arguments, and have the ability to articulate and write the results of all findings. 

Before applying for the RAQA PhD program, all candidates must spend time thinking about and formulating a thesis proposal, which must be included with the application. The strength, sophistication, and need for the thesis dissertation will be the deciding factor in the selection of the candidate.

Eligible applicants must have

  • master’s degree in RA and/or QA or a pharmaceutical or science degree from an accredited institution of higher learning;
  • A minimum of fifteen years of work experience that is related to their PhD thesis proposal and which demonstrates ascending responsibility and/or supervisory authority in RA/QA, pharmaceutical, or related sciences in any of the following areas that draw heavily on regulatory policy and quality assurance implementation: quality practices, corporate drug development, corporate manufacturing science, clinical and pharmacovigilance supervision and analysis, analytical methods, validation implementation, etc. 
  • Current work experience that can be applied to the topic they are investigating for their PhD thesis;
  • The ability to work both independently and as part of a team, displaying recognizable initiative;
  • A willingness to pursue original, independent research, utilizing a multi-disciplinary approach to problem-solving;
  • Strong communication skills, both verbal and written, including the ability to write academic research papers containing original thought and cogent arguments;
  • The ability to accept constructive criticism and welcome feedback provided by the Thesis Advisory Committee or Thesis Advisor;
  • The willingness to commit the necessary personal time in pursuit of the PhD thesis.
  • In addition, applicants must reside in the U.S.

All PhD candidates will be required to complete a graduate-level course in statistics. Additional RAQA coursework may be required at the direction of the Thesis Committee.

Application Process
Original copies of all application materials for the RAQA PhD must be mailed to:
Temple University – RAQA Graduate Program
Attn: PhD Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034

Photocopies of application materials may be emailed to: , but please be aware that original, hard copies of the application, official transcripts, CV, and letters of recommendation will only be accepted via mail to the RAQA Office. Photocopies, faxes, and scans will not be accepted.
The applicant is responsible for making sure that all materials are received by the RAQA Office by the stated deadline (no later than March 1, 2021, for consideration for the Fall 2021 semester.)

The following materials must be submitted:

  • $75.00 Application Fee. Checks must be made payable to Temple University.
  • Three letters of recommendation, including one from a direct supervisor. 

These letters should clearly discuss your ability to pursue advanced graduate level work and speak to your perseverance, intellect, and ability to do intensive research.

The letter from your supervisor should include a statement that he/she fully supports your involvement in a PhD program and is cognizant of the amount of time that will be required to organize, research, and write a thesis dissertation.

While the standard reference form (PDF) may be used, it is highly recommended that you ask references to submit more formal, detailed letters. Your reference should use official stationery/letterhead and provide complete contact information (name, title, address, daytime phone, and email).

  • A signed CV or resume.
  • Official transcripts from all institutions of higher learning attended which clearly indicate the degree received.
  • Statement of professional goals.
  • Students who have received degrees abroad must provide a course-by-course WES or ECE as well as a TOEFL (or IELTS)
  • A 5 – 10 page synopsis of your proposed thesis topic which includes:

    1. a thoughtful summary of the topic/area you intend to focus upon for your PhD thesis;

    2. sources and methodology you intend to use as you pursue your research;

    3. a list of several possible experts (from academia, industry or regulatory authorities) who might serve as advisors on a thesis committee, including their contact information. This does not mean that the experts will serve as members of the Thesis Advisory Committee; however, the list should demonstrate that the PhD applicant has given careful consideration to the thesis proposal and is familiar with appropriate experts who could help direct research on the topic.

Important: If you intend to use company sources, projects, or materials as part of your PhD dissertation research, you must include a letter from the company’s legal department stating that the material is not proprietary and may be included in a final PhD thesis.

Selection Process
We anticipate a large demand for the PhD in RAQA but can only accommodate a very select number of candidates. It is your responsibility to put together a succinct, cohesive, and compelling argument demonstrating why you should be selected from the applicant pool. We strongly suggest mailing all of your application materials in one packet.
The role of the RAQA Office is simply to gather application materials and forward them to the Graduate Committee for review. It cannot advise on the viability, format, or content of a thesis dissertation proposal.

Application Deadline
All applications for the RAQA PhD concentration must be received no later than March 1, 2021, for consideration for the Fall 2021 semester. If that deadline is missed, the application will not be considered (though it can be submitted for the Fall 2023 uptake).
Candidates will be required to meet with their Thesis Advisor and Thesis Committee either through Zoom, teleconferencing or in-person at least twice a semester (unless otherwise advised). 

Enrollment Requirements
Upon formal acceptance into the PhD program, the candidate must pursue the program during the fall and spring semesters every academic year until the PhD is completed. A summer semester may be substituted with the permission of the Thesis Committee, but typically leaves of absence are not permitted.

The PhD candidate is responsible for all tuition costs. No scholarships, research or teaching assistantships are available for the PhD program in RAQA. 
A flat fee (to be determined) per academic year (fall through summer) will be charged to each candidate for PhD supervisory activities, until the PhD thesis is completed.