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Regarding Masters in Regulatory Affairs

  • 1.  Regarding Masters in Regulatory Affairs

    This message was posted by a user wishing to remain anonymous
    Posted 04-May-2021 17:43
    This message was posted by a user wishing to remain anonymous

    Hello all,

    I am interested in doing a Masters in Regulatory Affairs ( been wanting to do a course that is either general or aimed towards Devices)  and have been researching on some colleges offering the same. I have shortlisted on the below. I was wondering if any one have done courses offered by any of the Universities below and if you would be kind enough to share your experiences.

    1. Massachusetts College of Pharmacy and Health Sciences, Boston-MA  Master of Science In Regulatory Affairs and Health Policy

    2.Temple University, School of Pharmacy, Philadelphia-PA  Master of Science in QA/RA

    3.Arizona State University,College of Nursing and Health Innovation, Phoenix-AZ

    Master of Science in Regulatory Science & Health Safety
    Course developed in collaboration with USFDA

    4. Johns Hopkins University, Centre for Biotechnology Education, Baltimore-MD.
    Master of Science in Bioscience Regulatory Affairs (Mainly deals with Biotechnology Regulatory Affairs
    Master of Science in Regulatory Science

    5.The University of Georgia, Gwinnett Campus, Lawrenceville-GA*  Master of Science for Regulatory Affairs

    6. North Western University, School of Continuing Education, Chicago-IL*   Master of Science in Quality Assurance and Regulatory Science 

    7. Tufts University, School of Medicine Master of Science in Development and Regulation of Medicines and Devices

    8. St. Clouds University  Masters in Regulatory Affairs and Services

    Thank you so much in advance!

    Regards.
    Anonymous :)-



  • 2.  RE: Regarding Masters in Regulatory Affairs

    Posted 05-May-2021 07:25
    I am currently doing a Masters in Regulatory Affairs with a concentration in Quality & Compliance at North Eastern University. I find it to be a very good program and have learned a lot so far. 

    https://www.northeastern.edu/graduate/program/master-of-science-in-regulatory-affairs-online-18361/

    ------------------------------
    Ellen Dark
    Data Coordinator, QA
    Waltham MA
    United States
    ------------------------------

    Original Message


  • 3.  RE: Regarding Masters in Regulatory Affairs

    Posted 05-May-2021 08:04
    I have been an Associate Professor in the Temple RAQA Program for over 20 years and more than happy to answer any questions you might have about the program. I am also part of the steering committee; we are constantly adding new courses and instructors to keep pace with the evolving regulatory and quality environment.

    With respect to medical devices, they have quite a few dedicated courses on the topic. Link to course descriptions. The Temple program can be done virtually or onsite or as a hybrid. Classes are live and instructor led and for the most part are at night or on the weekend so as not to interfere with work schedules. 



    Original Message


  • 4.  RE: Regarding Masters in Regulatory Affairs

    Posted 05-May-2021 08:10
    Hi Anon -
    Is there anything specific that you would like to ask? I did a second masters at Hopkins in Reg Affs, finished in 2016. The program had a lot of instructors who still worked for FDA in their respective area and the content was relevant. It made getting the RAC a fairly simple exercise, although I have not taken the med device RAC (I may, though). You can chose all online or in person, and JHU had a decent course catalog. The courses were challenging but not too much that you'd struggle working full-time and taking a class per semester (what I did).
    If you have any questions, let me know. It is definitely worth pursuing as it taught me a lot about what I don't know.
    Good luck!
    Holly

    ------------------------------
    Holly Bilinski, MS, RAC
    Ann Arbor, MI
    United States
    ------------------------------

    Original Message


  • 5.  RE: Regarding Masters in Regulatory Affairs

    This message was posted by a user wishing to remain anonymous
    Posted 05-May-2021 08:26
    This message was posted by a user wishing to remain anonymous

    Hi Anon,

    As an individual in RA for over 20 years, I consider all of these courses somewhat bogus.  Yes, they do provide what one would normally practically learn in the first two years on the job, and they do provide a great oversight of regulation.  However, they don't really prepare one for the "real world" of what may be required in your position.  If you think that a Masters will get you to a RA Managers position, it will/should not.  It is a good prep, but the  courses are mostly taught by people whose industry/regulatory body experience is 10+ years old.  Expect FD&C Act rules, not current matter.  No EU MDR, the treatment of the MDD is only cursory.  My only experience is with the institutions 4 and 5 on your list, and I am not impressed.
    Original Message


  • 6.  RE: Regarding Masters in Regulatory Affairs

    Posted 05-May-2021 09:10
    Hi Anon,
    I'd suggest you consider the elements of a post-grad education which provide value:
    1. acquiring knowledge
    2. possessing a degree/certificate that gives you credibility
    3. making connections with other aspiring professionals in your field​

    For example, if you live in Minnesota which is heavily medical device then either St. Cloud State University or University of St Thomas have good degree/certificate regulatory science programs where you'll make lots of local connections.

    If you do the program slowly, like one course per semester, you will cross paths with more people in your field.

    Finally, you should consider a certificate program. Certificates are cheaper, more focused and generally you can use the credits towards a Masters if you decide to continue.

    One advantage of full Master's programs is they usually have some element of leadership training. Unfortunately, that tends to mostly benefit people who were reasonably self-aware to begin with.

    minor correction: I believe  #8 is St. Cloud State University.

    ------------------------------
    Thomas Hoegh
    Edina MN
    United States
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    Original Message


  • 7.  RE: Regarding Masters in Regulatory Affairs

    Posted 05-May-2021 09:29
    Hello. I am currently going through the RA Certificate program at UGA, along with completing my Ph.D. I decided against the Master's Program because my dissertation work kept me busy enough. However, I had a great experience with the faculty that runs the program and all my professors. They are extremely professional and kind. I enjoyed the online courses, and whenever I needed extra time to complete the assignments, they were very understanding. I took many of the courses required for the Master's degree, and they were all excellent.

    I chose UGA's RA program because I am a student at the university, and I live in Athens. Everything was remote, so there was no need for me to travel to Lawrenceville, even before the pandemic. I highly recommend UGA's RA Masters and Certificate program. 

    Good luck with choosing the best option for you.

    -Angel Flores

    ------------------------------
    Angel Flores
    Ph.D Candidate (Genetics)
    UGA College of Pharmacy
    Athens GA
    United States
    ------------------------------

    Original Message


  • 8.  RE: Regarding Masters in Regulatory Affairs

    This message was posted by a user wishing to remain anonymous
    Posted 05-May-2021 15:05
    This message was posted by a user wishing to remain anonymous

    I did the Masters in Regulatory Science at the University of Southern California (USC) I didn't see that program on your list. They offer the program on the weekends and I found it very convenient to do that since you attend 4-5 8 hours sessions
    Original Message


  • 9.  RE: Regarding Masters in Regulatory Affairs

    This message was posted by a user wishing to remain anonymous
    Posted 05-May-2021 17:24
    This message was posted by a user wishing to remain anonymous

    Hi Anon,

    This is always a somewhat controversial opinion, but I agree with the Anon poster above who said these courses don't prep you for the real world. Now, I may be biased. I do not have a regulatory degree. I do have a BS and MS in technical fields. Every interview I've had has always focused on my regulatory knowledge but no one has cared how/where I obtained that knowledge, but rather on how I was able to apply it to specific situations. In my case, a few years ago I bought myself several of the RAPS fundamentals books, and have been going to at least one conference a year (more if I can manage, especially local 1-day workshops). Add in some webinars, lots of discussion on this very RAPS forum, completion of the RAPS Medical Device certificate, reading all kinds of guidances, and I've found that it's given me the knowledge I need to do my job and build experience. With all this I've been able to get to an RA manager position. Earlier in my career I actually felt insecure that I didn't have a formal regulatory degree. In hindsight, it actually feels like an advantage because I had never had anyone spoonfeed me any regulations. I had to read, understand, decipher, and apply them to my company's products by myself (I've worked at small companies with tiny RA departments). That experience has given me the confidence to interpret the gray in many regulatory situations.

    As an aside - I realize Northeastern is not on your list, but I'm saying this as it may be relevant to others: I've interviewed several people from the Northeastern program for intern/entry level positions, and I have been unimpressed. They can (somewhat) recite some regulations and acts, but their knowledge is spotty and out of date (like the other poster, very limited understanding of MDR and other new regulations/guidances, for example). Moreover, most of them do not seem to have the critical thinking skills I would like to see. Maybe that's on the professors, or maybe the curriculum is lacking, or maybe the program is not selective. I don't know the reason, but that's been my experience.
    Original Message


  • 10.  RE: Regarding Masters in Regulatory Affairs

    This message was posted by a user wishing to remain anonymous
    Posted 06-May-2021 15:13
    This message was posted by a user wishing to remain anonymous

    Hello Anon,

    I completed the the Masters program at St. Cloud State in 2016.  Most of my classmates were employed in the medical device field or where science professionals wanting to make the move to regulatory.  Quite a few students had masters/doctorate degrees already.  I came to the program with an extensive regulatory background related to human subjects research.  I did (and still) work at a large  academic institution.  I did an internship at a local device company that allowed me to be a major contributor to drafting a 510(k) submission.  The point being that as a non-industry employee, the course work provided the skills necessary to competently contribute to an eventual successful clearance.
    Original Message


  • 11.  RE: Regarding Masters in Regulatory Affairs

    This message was posted by a user wishing to remain anonymous
    Posted 10-May-2021 08:36
    This message was posted by a user wishing to remain anonymous

    I'll also add that I do not know the value of a regulatory education, nor have I had one. I have BS and PhD in engineering, and worked in the lab for 7 years. I then got a job in regulatory affairs, and led 3 projects through to approval that were innovative drug-device-software combination products 5 years after that. I learned regulatory mostly from reading guidances, reading articles from RAPS, MedTech Insight, and many other RSS feeds (thanks RAPS for the article on that), as well as watching webinars. I'm very glad for my technical degrees, as it helped me get deep in the science when that was needed. I should add that I've had a love of communication / writing / reading / influence (and college minor) which has helped tremendously. 

    Sometimes I wish I had gotten into regulatory sooner, but I also that that being deep in lab helped me build an understanding that has helped me take on more complex projects today. And in that case, maybe an education may have helped me get a foot in the door into regulatory. In my case, I had the technical expertise they needed for the regulatory position, so that is how I moved into regulatory.
    Original Message


  • 12.  RE: Regarding Masters in Regulatory Affairs

    This message was posted by a user wishing to remain anonymous
    Posted 17-May-2021 08:30
    This message was posted by a user wishing to remain anonymous

    Greenlight Guru covered this topic briefly in their excellent podcast entitled, "WHY DEMAND IS SO HIGH FOR REGULATORY & QUALITY JOBS (AND SHOULD YOU TAKE ADVANTAGE?)" (Episode 204): https://www.greenlight.guru/blog/high-demand-for-regulatory-quality-jobs
    Original Message


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