Regulatory Open Forum

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  • 1.  Graduate Programs Recommendations

    Posted 18-Jan-2016 03:55

    Hi All,

    I would like to ask for some recommendations in graduate programs that would aid a career in regulatory affairs.

    Some information about me: I have a B.S. in biochemistry and about 2 years of experience working in regulatory operations where my main responsibilities were document publishing and electronic submissions to FDA for my company's drug in the IND phase. I have also obtained the RAC(US) certification this past fall.

    As I was preparing for the RAC exam I realized how much more there is to learn about the regulatory field and would like to attend a program that can enable me to branch out from operations and into strategy.

    Recommendations for full-time programs are preferred. Another reason for attending a graduate program is for me to return to the US and hopefully be able to get a job and obtain residency afterwards.

    Your help is much appreciated.

    Best,

    Lisa

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    Lisa Chang RAC
    Regulatory Operations Associate

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  • 2.  RE: Graduate Programs Recommendations

    Posted 19-Jan-2016 03:29

    Hi Yuchun,

    I have enrolled myself for online program MS in Reg Affairs and Health Policy program offered by MCPHS University, Boston.

    The syllabus and course material is good and probably you can check if they have on campus program.

    Thank you !!

    ------------------------------
    Hrishikesh Dhongade
    Novartis Healthcare Pvt. Ltd.
    Hyderabad
    India

    Original Message


  • 3.  RE: Graduate Programs Recommendations

    Posted 19-Jan-2016 04:59

    Hi Hrishikesh,

    Thank you for the suggestion. I will look into their syllabus online. :)

    Best,

    Lisa

    ------------------------------
    Yuchun Chang RAC
    Regulatory Operations Associate
    Taichung
    Taiwan

    Original Message


  • 4.  RE: Graduate Programs Recommendations

    Posted 19-Jan-2016 07:17
    Edited by Christina Talley 19-Jan-2016 07:17

    Hi there,

    I recently completed the MS program through Northeastern University. I had to complete it through the online venu, but they have the full program on ground. I believe their on ground program would be wonderful. 

    When looking for programs that I wanted to choose and study, I also looked at two others. Northwestern has one (Chicago) and USC. USC is also the first with a doctorate program. That I believe is only available on ground. 

    One advantage to taking my classes online is the wonderful learning I was able to take away by the almost "forced" collaboration with classmates through discussion boards and such. We all had such vastly different backgrounds. Many times I was the sole trials person. It was good for me to be exposed to information on that scale in industries of which I am not working in regularly. 

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    Christina (Lopez) Talley, MS, RAC, CCRP
    Baylor College of Medicine
    Houston TX
    United States

    Original Message


  • 5.  RE: Graduate Programs Recommendations

    Posted 19-Jan-2016 08:11

    I am partial to the Temple University Masters in RAQA Program in Ft. Washington PA. They have a mixture of both online and face-to-face classes. I have been an educator in their program for 18 years. Temple has one of the longest established programs in this discipline and their adjuncts are professionals in the BioPharmaceutical and Medical Device Industries as well as from FDA.

    If you need additional information concerning this program feel free to reach out to me directly or check their website at Online Master of Science Regulatory Affairs and Quality Assurance Temple University

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    Linda Bowen RAC, FRAPS
    Chair NJ NY RAPS Chapter
    Adjunct Professor Temple University

    Original Message


  • 6.  RE: Graduate Programs Recommendations

    Posted 19-Jan-2016 10:04

    I recommend the University of Southern California Graduate program in Regulatory Affairs. It has a long history of providing a great education. It is located in the College of Pharmacy. 

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    Edwin Bills RAC, MA
    Consultant
    Overland Park KS
    United Statesi

    Original Message


  • 7.  RE: Graduate Programs Recommendations

    Posted 20-Jan-2016 13:00

    Hello Lisa,

         Another recommendation is to check out Keck Graduate Institute of Applied Life Sciences (KGI).  They are located in Claremont, CA (~40 miles east of Los Angeles) and offer a 2-year, full-time, on the ground program leading to a Masters of Bioscience degree.  The program of study is more broadly focused on all aspects of drug/device/biological product development overall rather than on regulatory affairs only, and there is a "focus track" that would allow you to spend much of your second year focusing on clinical and regulatory affairs courses.  There is also a business of bioscience component to the program (classes such as organizational behavior and corporate finance) that helps you to understand that side of the industry. 

    I attended KGI, so I am biased, but I think the school provides a good foundational understanding of many aspects of the pharma/biotech/device industries, allowing you to think more strategically about your role in the product development process. If interested, here is a link to the school's website (www.kgi.edu), and please feel free to contact me if you would like to learn more about the school.

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    Regards,
    Hutch Humphreys RAC
    Associate Director Regulatory Affairs
    Samumed, LLC
    San Diego CA
    United States

    Original Message


  • 8.  RE: Graduate Programs Recommendations

    Posted 20-Jan-2016 16:38

    I would like to show you this article --> The Future of the Regulatory Profession-A Highly Educated Talent Pool

    Raps remove preview
    The Future of the Regulatory Profession-A Highly Educated Talent Pool
    The Future of the Regulatory Profession-A Highly Educated Talent Pool 2014-01-29 false In this article, author Sylva Krizan discusses obtaining an advanced degree before beginning a career in regulatory affairs, and in particular advanced degrees in regulatory affairs. When I entered the regulatory professio
    View this on Raps >

    Shows different schools, etc. I highly recommend going to Regulatory Convergence too as there are universities there in the exhibit halls.  I have spent lots of my time looking over the different programs and talking to people.  That was very helpful for gathering information so you can figure out what you want to do for schooling.

    Hope that helps,

    Clarisa

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    Clarisa Tate
    Medical Device, RA & QA
    Bay Area, CA
    USA

    Original Message


  • 9.  RE: Graduate Programs Recommendations

    Posted 21-Jan-2016 02:33

    Thank you all for the great information and resources! :)

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    Yuchun Chang RAC
    Regulatory Operations Associate

    Original Message