Regulatory Open Forum

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  • 1.  Preventing the leakage of confidential information through agent

    Posted 14-Nov-2022 03:01

    Dear All,

    Could you advise us what you can do to prevent the leakage of information through foreign dealer?

    We had asked a sample of application document to a dealer in South America and they provided us a confidential information of the other company as an example. It is highly likely they may do the same thing to our company's document. 

    There may be two options (if anything else, please advise!):
    1. Prevent the dealer from leaking our confidential information.
       Of course, we will tell the dealer not to do the same thing to our document, but is there anything more we can do?
    2. Not to provide technical secret in application, 
      I believe option 2 is better but do regulatory authority accept a masked risk management table or the like?

    Regards,



    ------------------------------
    Soichiro Iida
    Kyoto
    Japan
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  • 2.  RE: Preventing the leakage of confidential information through agent

    Posted 15-Nov-2022 07:18

    Dear Soichiro,

     

    We cover the non-disclosure in our contracts with our importers/distributors.  If we do not have a contract, then we have an NDA.  We have not found where regulatory authorities will accept redacted documents, so we have always had to provide the confidential information.

     

    Kind regards,

    Michelle

     

    D. Michelle Williams, CESCO

    VP – Operations

     

    Action Products, Inc.

    www.actionproducts.com

    301.797.1414 X1022

     

    https://www.linkedin.com/in/dmwilliamsvpopapiwvu88

     

     

    Action-MMD-Ribbon_Logo_5in_cmyk

     






  • 3.  RE: Preventing the leakage of confidential information through agent

    Posted 15-Nov-2022 21:57

    Dear Michelle,

    Thank you for the reply.

    It is very helpful to know that the authority is unlikely to receive redacted documents. 

    Actually, we had once tried submitting redacted documents and the authority received it at that time, however, it shall be an exceptional case.  Moreover, it is rather difficult for us to keep on preparing redacted documents.

    Thanks to your information, we can inform internally that authorities generally don't accept redacted documents.  

    Regards,
    Iida



    ------------------------------
    Soichiro Iida
    Kyoto
    Japan
    ------------------------------



  • 4.  RE: Preventing the leakage of confidential information through agent

    Posted 15-Nov-2022 09:08
    Dear Soichiro,

    A vendor sharing confidential information of another client should be a huge red flag about the business practices of the vendor. There is not much you can do with an ethical lapse on the part of a vendor other than a frank confrontation with the vendor's management. If there is not a clear statement that the behavior was unacceptable and will not be repeated, I would sever relationship with that vendor.

    If you can't be confident that a vendor or partner is going to respect confidentiality of proprietary information, they should not have a relationship with them.

    ------------------------------
    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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  • 5.  RE: Preventing the leakage of confidential information through agent

    Posted 15-Nov-2022 22:12

    Dear Glen,

    Thank you so much for the advice.
    Our company already asked them "not to do it" again. 
    We also want to ask our sales department to find a certain level of dealer and your advice is of great help!

    Actually, I had experienced to receive the other company's document a few times previously. At that time, it seemed that those dealers are not aware that such behavior is not acceptable. (Rather, they just want to provide us good sample documents.)
    Anyway, if they provide our information with good will or bad will would not help us. 

    Thanks again for the good advice!

    Regards,
    Iida



    ------------------------------
    Soichiro Iida
    Kyoto
    Japan
    ------------------------------