Regulatory Open Forum

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  • 1.  RAPS Regulatory Affairs Certificate Program

    Posted 05-Jul-2016 15:50

    Dear RAPS members,

    I am a pharmacologist with 15 years of industry experience in R&D, and I have decided to pursue a career in Regulatory Affairs. I am considering applying for the RAPS Regulatory Affairs Certificate Program - Medical Devices and Pharmaceuticals (Dual). I would like to know from someone who obtained this certificate if this was the only certificate that they pursued, and if they think that it was a good course. Also, I would like to know if it's feasible to complete all the 14 courses of the certificate in 12 months, when someone has a full time job, as I want to make sure I complete it if I decide to apply.

    Thank you so much for any suggestions and feedback anyone can provide.

    Warm regards,

    Alessandra

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    Alessandra Blasina, PhD
    Principal Investigator
    COI Pharmaceuticals, Inc.
    Ph 858-750-4741 
    ablasina@coipharma.com

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    Alessandra Blasina
    San Diego CA
    United States
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  • 2.  RE: RAPS Regulatory Affairs Certificate Program

    Posted 06-Jul-2016 12:05

    Hi Alessandra,

    I actually just finished up the dual certificates. I don't know if this is the only certificate but I took this because I get reimbursement from my employer for taking the classes. The classes took me about 6 months to finish considering that I am a full time postdoc and takes about 1-2 hours per day to study for the classes. I personally think the classes are very informative as I have no experience in regulatory but have dealt with more of techonology transfer between my institution and other academic and pharmaceutical institutions.

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    An Dao
    Postdoc fellow
    Baylor College of Medicine
    Houston TX
    United States

    Original Message


  • 3.  RE: RAPS Regulatory Affairs Certificate Program

    Posted 06-Jul-2016 22:11

    Given that An was able to complete the dual program in 6 months, I will suggest you consider doing just the pharma certificate.  Although there are some classes of products that require expertise in both drug and device RA, most RA positions are one or the other, and once you get into the profession, opportunities to cross over from one to the other will be very limited.  Pharma strongly prefers to hire pharma RA professionals; medical devices strongly prefer device RA professionals.

    This would leave you having to invest more time and money to do the device program later, should the need arise, but unless you have clear expectations of working with both, the need is not all that likely to arise

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com

    Original Message


  • 4.  RE: RAPS Regulatory Affairs Certificate Program

    Posted 25-Jul-2016 12:01

    I only took the Medical Devices certificate program - it took me 2 months to complete while working full time. I was actually able to take and pass some of the courses without completing the entire course review. I work with medical devices so I think some of the knowledge from my job helped me answer the questions. (not having to review an entire course before the assessment saved me a few hours) But just wanted to provide you with my experience it. Overall I enjoyed it! Good luck!

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    Christine

    Original Message


  • 5.  RE: RAPS Regulatory Affairs Certificate Program

    Posted 03-Aug-2016 10:13

    I completed the dual program in about 6 months and work on the pharma side, but thought the Device would be an added benefit in case we ever end up with a combination product.  While I found the program informative and found that it provided lots of Regulatory background, it is clearly not a Masters program, which is preferred by employers.  I found it difficult to find background reviews on this program to determine whether it added any career benefits to anyone who completed it.  That being said, it was a fraction of the cost of a Masters program. I also only had access to the course material for 1 year (with the exception of my own notes) so when I tried to go back to one of the courses (after completion) to find information, I was unable to do so.  My boss told me that she thought obtaining RAC certification would be more beneficial career-wise than completing the certificate program, but alas, I have now done both.  To sum up, I didn't think it was a life-changing experience, but it was $3000 versus $25000 to do a Masters and definitely provided a knowledge-base if you do not have Regulatory experience.  Hope this helps!

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    Amanda Kennedy RAC
    United States

    Original Message