Regulatory Open Forum

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  • 1.  Recommendations on Clinical Research Training/Courses

    Posted 20-Aug-2021 05:23
    Hi, I am a regulatory affairs expert (Director level with focus on FDA and medical devices) and I am trying to expand my expertise into the clinical domain to be able to “sell” myself in the future as RACA Director.

    My company is also planning to start clinical trials in USA soon (we currently have clinical activities only in Europe) and my support will be needed.
    I have already been exposed to clinical trials and documentation, but always in a partial and indirect way, mostly as a regulatory reviewer. I also helped writing some documentation (CRF, investigator brochure, non-significant risk determinations, etc).
    I also used all the resources available in the fda website (cdrh learn, webinars, etc)

    My company is willing to pay me a remote training and I am looking for suggestions on good 3-4 days training/courses on clinical research. I am interested in something that touches a little bit of everything (iso 14155, GCP, Code of Federal Regs, Monitoring, HIPAA, etc). My focus and main interest is USA but since I work and live in Europe I am also open to EU-focused courses. After all, I believe differences are minor.

    Thanks in advance for any recommendations you can provide.
    I am also happy to get general suggestions on strategies to make efficiently this step in my career (e.g., need of specific certifications, etc.)
    Best
    Maria

    ---------------------------------
    Maria Ida Iacono


    Paris
    France
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  • 2.  RE: Recommendations on Clinical Research Training/Courses

    Posted 21-Aug-2021 06:08
    Hi Maria

    I will recomend you to check NSF. They are great providing training and have excellent courses online too. I have two main contacts that you can reach out to:

    James Pink | Senior Director | Health Sciences

     

    NSF International | The Georgian House, 22-24 West End, Kirkbymoorside, York, United Kingdom, YO62 6AF | +44(0)7850900569| http://www.nsf.org | jamespink@nsf.org

    Starting August 23, 2021 my new point of contact is Oliver Christ, Managing Director Health Sciences EMEA & (acting) Global Medical Device Consulting. He can be reached at:

    Email: ochrist@nsf.org
    Telephone: +49 170 274 3671 


    Thanks

    Patricia Tolmos

    ------------------------------
    patricia tolmos
    Amersham
    United Kingdom
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    Original Message


  • 3.  RE: Recommendations on Clinical Research Training/Courses

    Posted 21-Aug-2021 12:15
    These are the programs I know of that have courses that you are looking for:
    1. My employer, which is a research site, requires all employees to take courses from The Collaborative Institutional Initiative (CITI) Program.  The email address is: https://about.citiprogram.org.

    2. I'm a member of the Association of Clinical Research Professionals, which has many courses available.  Non-members have to pay a higher fee.

    Pamela Shonk, RN, BSN, MS, CCRC, CCRP, ACRP-PM, ACRP-CP, ACRP-MDP 




    Original Message


  • 4.  RE: Recommendations on Clinical Research Training/Courses

    Posted 22-Aug-2021 13:09
    In previous years the FDA provided a clinical Investigator training entitled, "Regulatory Education for Industry (REdI): Clinical Investigator Training Course." I checked their website and the last time it was provided was November 2019. The Agenda, slides and recordings of the presentations are available for free at this link.

    I highly recommend the CDER Small Business and Industry conferences and webinars, taught by FDA employees and FREE! You can see their catalog of past and future events here. 

    And if you want to learn more about medical devices, try out CDRH Learn. Also free and taught by FDA employees.



  • 5.  RE: Recommendations on Clinical Research Training/Courses

    Posted 23-Aug-2021 11:47
    Thank you all, I really appreciate all the great suggestions (I got some also by email, thanks Ted!)
    Concerning CDRH learn, FDA webinars, and CITI courses, I have already attended several in the past. This time I was hoping for something more interactive with a coach and the possibility to ask questions.
    In any case, I will check again all the resources you proposed. 
    Thanks again for your help
    Maria

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    Maria Ida Iacono
    Paris
    France
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    Original Message


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