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Ask Me Anything Session: The Shifting Global Regulatory Landscape

  • 1.  Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 01-Jul-2020 12:06
    Edited by Eileen Quinn 08-Jul-2020 09:45

    Hi RegEx members,

    Recently, RAPS released its' Quarterly Regulatory Focus Article Series, The Shifting Global Regulatory Landscape. We will be hosting an "Ask Me Anything" session on Wednesday, 8 July, from 1:30-2:30 PM ET here on RegEx. We will have three regulatory experts, @Jordanna Jayne, @Tammy Pelnik, @Darin Oppenheimer, and @Siegfried Schmitt, who will be discussing the articles in real-time and available to answer your questions.


    If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event. 


    Looking forward to seeing your questions!

    Best,
    Annie


    ------------------------------
    Annie O'Brien
    Community Manager
    Regulatory Affairs Professional Society
    regex@raps.org
    ------------------------------​


  • 2.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 13:30

    The AMA is starting--post your questions for our experts below!



    ------------------------------
    Annie O'Brien
    Community Manager
    Regulatory Affairs Professional Society
    regex@raps.org
    ------------------------------



  • 3.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 13:32
    A question on my mind is… what is the best way to deal with legacy medical devices as we transition to EUMDR? Are rationales based on years of safe use likely to be acceptable to notified bodies? By legacy devices I'm referring to devices that have been on the market for decades, developed and launched before our current design controls were in process, and as such may not have complete documentation on file.

    ------------------------------
    Dolan Mills RAC
    Principal Specialist, Regulatory Affairs
    Bartlett TN
    United States
    ------------------------------



  • 4.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 13:34
    For MDR, there is no grandfathering rule. Every CE marked device on the market must comply with MDR by May 2021. If there are holes in the technical documentation required these need to be filled. If, for example, you require additional clinical evidence to be compliant, you may be able to leverage scientific peer-reviewed published literature or Real-World Data/Real-World Evidence (RWD/RWE) to supplement your documentation. RWD/RWE studies can be a way to use existing data from Electronic Health Records (EHR) to demonstrate safety and effectiveness but, the data must be of sufficient completeness, quality and provenance which can be challenging.

    ------------------------------
    Jordanna Jayne
    Regulatory Affairs Specialist
    San Diego CA
    United States
    ------------------------------



  • 5.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 14:12
    Legacy devices and data from inherited devices is a challenge for many manufacturers one of the silver linings is the robust post market safety data that you have been collecting for that extended period of time. I would look through this carefully and try to select tests to bridge the gaps in the overall objective evidence. It may be beneficial to have a conversation with your Notified Bodie as well to discuss your proposed path of reaching compliance in the absence of some data.

    ------------------------------
    Darin Oppenheimer FRAPS, RAC
    Executive Director
    Medford NJ
    United States
    ------------------------------



  • 6.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jul-2020 13:35
    This message was posted by a user wishing to remain anonymous

    Can anyone share reading and training material how to best integrate (or collaborate) Quality Product Complaint information with Drug Safety Database information? In particular, for device combination products. There is a push by regulators in using MedDRA terminology, and in particular how they all roll-up under "Medication Error". What is the best work stream and how can we leverage work between departments rather than duplicating?


  • 7.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 13:46
    Thank you for the response. This has been a challenging area for many combination product manufacturers. I would like to take this offline and dig into this further, so I can provide you a thorough response with additional material.

    ------------------------------
    Darin Oppenheimer FRAPS, RAC
    Executive Director
    Medford NJ
    United States
    ------------------------------



  • 8.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jul-2020 13:42
    This message was posted by a user wishing to remain anonymous

    Is there any update on EU and UK with regards to approved Marketing Applications. I was aware that EU granted MA would be 'grandfathered in', but still needed a submission to UK. Rumors were the 1-year transition would be extended. Any update?


  • 9.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 13:47
    Yes the current word from MHRA is that there will be a transition period. Given the protracted negotiations with the EU, and the current Covid crisis, a longer period than 1 year is quite possible

    ------------------------------
    Siegfried Schmitt
    Vice President Technical
    Braintree
    United Kingdom
    haag33@yahoo.com
    ------------------------------



  • 10.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 13:51
    Yes, MHRA proposed that, if a no-deal Brexit takes place, all currently granted Centrally Authorized Products (CAPs) automatically become UK market authorizations on exit day. The guidance document said Marketing Authorization Holders would have 1 year from exit day to provide MHRA with baseline data for CAPs that were converted into UK Marketing Authorizations. However, since that guidance document was released, it has subsequently been withdrawn. As far as I am aware, MHRA have not released any other updates at this point.

    ------------------------------
    Jordanna Jayne
    Regulatory Affairs Specialist
    San Diego CA
    United States
    ------------------------------



  • 11.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jul-2020 13:49
    This message was posted by a user wishing to remain anonymous

    For @Siegfried Schmitt: Are you aware of any specific agreements between US FDA and EU regarding the sharing of clinical data between US and EU? (related to article statement: "MyStudies system has an interface that could allow an external system, such as the EU portal, CTIS, to retrieve data from the MyStudies storage environment")




  • 12.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 13:54
    The Mutual Recognition Agreement doesn't extend to the specific sharing of clinical data (sharing of inspection findings however yes). Given the massive technical issues with the implementation of the EU clinical trial portal, I am certain that priority is given to get the EU database working before any connectors will be activated (e.g. to the US databases)

    ------------------------------
    Siegfried Schmitt
    Vice President Technical
    Braintree
    United Kingdom
    haag33@yahoo.com
    ------------------------------



  • 13.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 13:58
    Hi Experts!

    Another great question has come in: Any update whether we would need a UK-specific QP and QPPV?

    ------------------------------
    Annie O'Brien
    Community Manager
    Regulatory Affairs Professional Society
    regex@raps.org
    ------------------------------



  • 14.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 14:00
    This is a definite yes. Although MHRA has indicated that again there will be a transition period

    ------------------------------
    Siegfried Schmitt
    Vice President Technical
    Braintree
    United Kingdom
    haag33@yahoo.com
    ------------------------------



  • 15.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jul-2020 14:01
    This message was posted by a user wishing to remain anonymous

    @Tammy Pelnik Have there been any statements from regulators regarding relaxing audit requirements for "non-essential" manufacturers that have most non-production staff working remotely?


  • 16.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 14:03
    Not that I'm aware of - the regulatory expectation is that a manufacturer will continue to follow their Quality Management System (i.e., operate within GMP requirements). If remote internal audits are going to be adopted, appropriate changes in the QMS may be needed (e.g., updating SOPs). Continuing with an internal audit program, using some new auditing methods, is likely to be helpful in identifying new compliance issues under the altered operating models related to COVID.

    ------------------------------
    Tammy Pelnik, MS, IRCA Principal QMS Auditor
    President
    St. Vrain Group
    Boulder CO
    United States
    ------------------------------



  • 17.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 14:07
    To add to Tammy's response - yes you must continue operating your quality system. Given that remote audits are nothing new, this should already be part of your quality system. Please be aware that certain regulators (e.g. in Germany) insist that audits by Qualified Persons of API and Drug Product sites still must go ahead in person.

    ------------------------------
    Siegfried Schmitt
    Vice President Technical
    Braintree
    United Kingdom
    haag33@yahoo.com
    ------------------------------



  • 18.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jul-2020 14:12
    This message was posted by a user wishing to remain anonymous

    @Darin Oppenheimer Will ISO certificates be revoked if on-site audits will not be possible?



  • 19.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 14:22
    While we are managing through these interesting times. It is important to understand that registrars and other agencies are being flexible as well. I do not believe a rule has been stated to revoke ISO certs if on-site audits will not be possible. Auditing can be performed through a hybrid approach utilizing desktops, virtual, and onsite. These flexible approaches can help  to achieve the overall goal of the inspection and provide adequate safety measures for the participants and staff.

    ------------------------------
    Darin Oppenheimer FRAPS, RAC
    Executive Director
    Medford NJ
    United States
    ------------------------------



  • 20.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jul-2020 14:23
    This message was posted by a user wishing to remain anonymous

     @Jordanna Jayne How is the Postmarket Performance Followup requirement different than the requirement to maintain the Risk Management File with emerging risk information?


  • 21.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 14:26
    From my understanding, the Postmarket Performance Follow-Up is the link between the PMS System (which includes risk management) and Performance Evaluation. So, the risk management requirements feed into the Postmarket Performance Follow-up.

    ------------------------------
    Jordanna Jayne
    Regulatory Affairs Specialist
    San Diego CA
    United States
    ------------------------------



  • 22.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 09-Jul-2020 08:13

    You asked, "How is the Postmarket Performance Followup requirement different than the requirement to maintain the Risk Management File with emerging risk information? "

    I don't know of a requirement to identify and maintain emerging risk information in the Risk Management File. For example, EN ISO 14971:2019 doesn't use the term "emerging risk".

    The IVDR uses the terms "emerging risk" and "emergent risk" without defining either one.

    The PMPF system requires, "detecting emerging risks on the basis of factual evidence".

    The PMPF plan specifies the methods and procedures for "identifying and analyzing emergent risks on the basis of factual evidence".

    I don't know what an emerging or an emerging risk is, so I'm not sure how to look for them. However, if there were one, I would add it to the risk management file as a risk associated with the foreseeable hazard.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------



  • 23.  RE: Ask Me Anything Session: The Shifting Global Regulatory Landscape

    Posted 08-Jul-2020 14:30

    Thank you all for joining us for this great session and a big thank you to our experts @Jordanna Jayne, @Siegfried Schmitt, @Darin Oppenheimer, and @Tammy Pelnik!

    As a reminder, you can find the Regulatory Focus Article Series: The Shifting Global Regulatory Landscape here.

    Feel free to keep the conversation going by adding your question to this thread.

    Thanks again!

    Annie

    ​​​​

    ------------------------------
    Annie O'Brien
    Community Manager
    Regulatory Affairs Professional Society
    regex@raps.org
    ------------------------------