Regulatory Open Forum

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  • 1.  MS - Regulatory Science

    Posted 26-Jul-2012 13:59
    Hello,

    If given a choice to select MS in Regulatory Science at USC or John Hopkins, which one should be selected?

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    Kunjan Shah
    Campbell, CA
    USA
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  • 2.  RE:MS - Regulatory Science

    Posted 27-Jul-2012 15:40

    Hello Kunjan,
    I don't know much about the program at USC but I can speak from experience with regards to the JHU program. I think its on of the best RA program you would find in the country. Most of the professors are industry experts. The assignements seek to emphasize on real life situations and reinforce concepts in the class lessons. I hope this helps.
    Cheers.
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    Kweku Biney
    Mechanicsville VA
    United States
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  • 3.  RE:MS - Regulatory Science

    Posted 28-Jul-2012 12:40

    You might also want to consider the Temple University QA/RA program.  It's the oldest and largest of the RA MS programs.

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    Jonathon Parker
    Senior Director
    Pfizer Inc
    East Lyme CT
    United States
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  • 4.  RE:MS - Regulatory Science

    Posted 29-Jul-2012 13:31

    Hi Kunjan et al. -

    I am currently about half way through the USC Masters program and I can speak VERY HIGHLY about the program.  There is a broad range of industry experts (Pharma, Device, Healthcare), FDA officials and even innovators that are brought in to the program to speak and beautifully augment the rigorous curriculum with real world practice.  The projects and assignments provide opportunities for experience in regulatory and QA roles as an example - writing a complete 510K.

    The program addresses everything from biologics, generics, combinations to devices.  The director of the program - Dr. Frances Richmond is on the board of DIA (Drug Information Association) and is EXTREMELY well connected within the industry having also come from industry herself as a Neuroscientist.  She has established connections with DIA for joint programs as well as other local regulatory associations - OCRA (Orange County Regulatory Association), etc.

    The program, I believe, is the only international program and examines, compares, contrasts all regulatory bodies globally.  The Doctoral program tours and meets with these various global regulatory authorities as well.  

    Please feel free to reach out to me for any further info or questions.

    Karen Jaffe
    USC Medical Regulatory Sciences
    School of Pharmacy
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    Karen Jaffe
    Irvine CA
    United States
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  • 5.  RE:MS - Regulatory Science

    Posted 30-Jul-2012 08:12
    I am very familiar with the USC program and the UW program having taught risk management at both programs.  I would echo the statements by Karen on the USC program.  It is mature and currently has at least one PhD candidate working on his dissertation (a friend of mine), who has made highly complementary statements about the program and its rigor.  Dr. Richmond is well known and runs a well-respected program, I would highly recommend that you consider this program.




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    Edwin Bills RAC, ASQ Fellow
    Principal Consultant
    Bilanx Consulting LLC
    Sumter SC
    United States
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  • 6.  RE:MS - Regulatory Science

    Posted 30-Jul-2012 09:12
    For the past several years, I have advised some professionals relating to obtaining RAC, MS in RA, Doctoral degree in RA, etc.  Last Saturday, I advised my friend FDA employee regarding RAC and CQA. 

    I have met, communicated, recommended and/or worked with those who are/were holding MSs and is finishing his Doctoral degree at USC.  My former trainee is currently attending MS program at Johns Hopkins per my recommendation due to her unique circumstances.  I also recommended USC doctoral program.  In fact, she chose not to go to USC because of the title (Doctor in RA) as she wanted to get her Ph.D.  I am currently working with those who got his MS in RA and are currently attending Masters' Program in RA at Northeastern University (http://www.cps.neu.edu/degree-programs/graduate/masters-degrees/masters-regulatory-affairs.php/ 
    ). I also interviewed with someone who got his MS from Cloud State (http://www.stcloudstate.edu/ras/) and had a chance to review their program including the list of classes and the list of professors.  I also have some experience in classes at UC-San Diego and Johns Hopkins.  

    Taken together, each program is distinct and has some specialty.  In terms of the quality of the program, it is hard to discriminate against each other and thus, each program is worth considering.  

    But I would recommend you consider the following factors GIVEN your background and the currently situated circumstances.

    1. Cost ($$)
    2. What the program offers, meeting your background and your goals (drug/biologics focused vs. device focused)
    3. Class requirements (e.g., prerequisite)
    4. MS in RA or Doctor in RA
    5. List of professors with their background (industry experience)?
    6. Name/location

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    www.RegulatoryDoctor.com
    Floyd VA
    United States
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  • 7.  RE:MS - Regulatory Science

    Posted 29-Jul-2012 22:09
    The programs at USD and Johns Hopkins are great (I did my postdoc at JHU), but since I teach in the QA/RA program at Temple, I also recommend it very highly.

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    John Parker PhD
    Senior Director RA and Quality Systems
    Vaccinex, Inc.
    Rochester NY
    United States
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  • 8.  RE:MS - Regulatory Science

    Posted 30-Jul-2012 08:54

    Hello Kunjan.

    I, like Kweku, have some personal experience in the Johns Hopkins program.  I looked at all of the programs noted as available from RAPS and it really came down to the fact that for the time and opportunity that the JHU program offered, it was best for what I needed and wanted.  More importantly, in some instances you actually also have professors in the program from FDA which, while they cannot speak for or on behalf of FDA, the ability to see the way that an FDA reviewer thinks through an application is of such value that it is almost absolutely necessary!
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    Victor Mencarelli
    Regulatory Affairs Team Leader
    United States
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