Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi forum, 
I am looking for tips and reference readings for the preparation of our Q-sub (pre-submission) meeting. It is our first interaction with the FDA and it was supposed to be in person, but it got converted into a teleconference due to the current situation. 
Some points that I have in mind are the following:
- Structure of the Powerpoint presentation. Is it better to have some introductory slides (or videos) on the device (however, the reviewer has already read the pre-submission + I guess this is more in the scope of informational meetings, not pre-subs) or go directly to the responses to their feedback? How many slides?
- Suggestions on the best way to prepare for the meeting (and the responses to the feedback) while waiting for the written feedback?
- Should the presentation be sent in advance to the FDA? How long in advance? 
- Can you confirm that the teleconference will be audio only (+ share screen for the presentation)?
- Suggestion on how logistically tackle the challenge of the very limited time (5 days) to prepare/respond? Are these 5 working days?
- Roles? Should one single person (e.g., RA?) present it all or should each team expert address his/her specific topic/question? 
- Suggestions on behavior best practices to share with the team?
- Can the meeting minutes be sent to the FDA by email or should they be physically mailed under the e-Copy program?
- Any other tip/point I am missing?
Thanks for any suggestion or reference you can provide.

Good day,

Preparing for a Q-Submission meeting is important whether face-to-face or teleconference.  Keep in mind you probably only have 1 hour to discuss your Q-Submission request, so yes you can have a Powerpoint presentation or introduction to the product but should be limited to 5 - 10 minutes.  The presentation should be sent to FDA in advance, since many of their participates only dial in on phone, but at least they can scroll through the presentation.  Video, would stay away from that - if you send a video just have this for the FDA persons own availability to view in advance.  Consider it is audio only, again some participants from FDA may be calling in my an office or home where they can not share a screen.  You have to be flexible when going into a Q-Submission meeting - but definitely put an agenda together for the different topics, e.g. 5 min introduction, 5 min product review, 5 min presentation, 10 min present current regulatory needs, then 30 minutes for review of questions.  The FDA will read your Q-Submission request with areas of feedback and provide a written response about 5 days in advance of the meeting.  In this way the actual teleconference should be review of any "sticky" or difficult points that are still not clear.  As an example, the Q-Submission feedback says we will have 50 patients, FDA responds acceptable in writing.  Do not need to cover in the meeting.  In the Q-Sub feedback there is a question about a specific performance test, FDA responds with some information, but maybe you need more clarification - this should be covered in the teleconference.  Roles should be the main contact and person managing the meeting (FDA does not manage the meeting - or should not manage - it should be managed by the company), someone to take notes because you need to write meeting minutes, and then an SME or two.  You can have as many people on the phone, but only 1 or 2 people should speak because it can get confusing with multiple people talking.  Also a good hint, whenever you start talking state your name so FDA knows who is actually talking.  I send the draft meeting minutes to the reviewer through email, but the "official" meeting meetings need to be sent in eCopy version to the DCC address.  There are lots and lots of other tips, but could probably write a 10 page white paper on this !

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 16-Apr-2020 09:54
From: Anonymous Member
Subject: prepare pre-sub teleconference

This message was posted by a user wishing to remain anonymous

Hi forum,
I am looking for tips and reference readings for the preparation of our Q-sub (pre-submission) meeting. It is our first interaction with the FDA and it was supposed to be in person, but it got converted into a teleconference due to the current situation.
Some points that I have in mind are the following:
- Structure of the Powerpoint presentation. Is it better to have some introductory slides (or videos) on the device (however, the reviewer has already read the pre-submission + I guess this is more in the scope of informational meetings, not pre-subs) or go directly to the responses to their feedback? How many slides?
- Suggestions on the best way to prepare for the meeting (and the responses to the feedback) while waiting for the written feedback?
- Should the presentation be sent in advance to the FDA? How long in advance?
- Can you confirm that the teleconference will be audio only (+ share screen for the presentation)?
- Suggestion on how logistically tackle the challenge of the very limited time (5 days) to prepare/respond? Are these 5 working days?
- Roles? Should one single person (e.g., RA?) present it all or should each team expert address his/her specific topic/question?
- Suggestions on behavior best practices to share with the team?
- Can the meeting minutes be sent to the FDA by email or should they be physically mailed under the e-Copy program?
- Any other tip/point I am missing?
Thanks for any suggestion or reference you can provide.

Original Message------

Good day,

Preparing for a Q-Submission meeting is important whether face-to-face or teleconference.  Keep in mind you probably only have 1 hour to discuss your Q-Submission request, so yes you can have a Powerpoint presentation or introduction to the product but should be limited to 5 - 10 minutes.  The presentation should be sent to FDA in advance, since many of their participates only dial in on phone, but at least they can scroll through the presentation.  Video, would stay away from that - if you send a video just have this for the FDA persons own availability to view in advance.  Consider it is audio only, again some participants from FDA may be calling in my an office or home where they can not share a screen.  You have to be flexible when going into a Q-Submission meeting - but definitely put an agenda together for the different topics, e.g. 5 min introduction, 5 min product review, 5 min presentation, 10 min present current regulatory needs, then 30 minutes for review of questions.  The FDA will read your Q-Submission request with areas of feedback and provide a written response about 5 days in advance of the meeting.  In this way the actual teleconference should be review of any "sticky" or difficult points that are still not clear.  As an example, the Q-Submission feedback says we will have 50 patients, FDA responds acceptable in writing.  Do not need to cover in the meeting.  In the Q-Sub feedback there is a question about a specific performance test, FDA responds with some information, but maybe you need more clarification - this should be covered in the teleconference.  Roles should be the main contact and person managing the meeting (FDA does not manage the meeting - or should not manage - it should be managed by the company), someone to take notes because you need to write meeting minutes, and then an SME or two.  You can have as many people on the phone, but only 1 or 2 people should speak because it can get confusing with multiple people talking.  Also a good hint, whenever you start talking state your name so FDA knows who is actually talking.  I send the draft meeting minutes to the reviewer through email, but the "official" meeting meetings need to be sent in eCopy version to the DCC address.  There are lots and lots of other tips, but could probably write a 10 page white paper on this !

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

This message was posted by a user wishing to remain anonymous

Thank you both for your help. 
Regarding the following point in the FDA guidance:
"Submitters that request a meeting should be aware that all meetings are subject to disclosure review pursuant to the Freedom of Information Act (FOIA)."
Do you recommend to include a statement at the beginning of the presentation to request confidentiality and nondisclosure of the meeting information?
Thanks again
Original Message:
Sent: 17-Apr-2020 10:37
From: Ted Heise
Subject: prepare pre-sub teleconference

 

 

Hi Anon,

 

You got very good responses from Richard.  I would just add a couple of points.

 

Regarding audio only, I guess you may have been asking indirectly whether it is possible or advisable to include video from webcams showing participants.  My experience has been that face to face meetings are optimal when starting any project, as it helps develop trust among the participants.  When it's not possible for meetings to be in person, seeing faces to go with the names is helpful.  My understanding is that FDA does have videoconferencing capabilities, and companies just need to request it.  Full success of such a process will of course depend on adequate internet bandwidth for any folks working from home.

 

Regarding length of presentation, I completely agree that it needs to allow ample time for discussion.  On the other hand, the issues driving the need for a presub are often complex technical matters.  As such, 10 minutes may be a bit on the short side to successfully lay out all of the science and reasoning.  The presentations I've given often run 15-20 minutes.  Admittedly, this should all be well laid out in the presub itself--but written text is a poor substitute for the nuance and clarity that come from a competent and well-spoken presenter.

 

Over the past several decades, MED Institute has led many dozens, if not hundreds, of presubs that helped our clients successfully proceed though the regulatory process.  If you have needs in this area, we can help.

 

Best regards,

 

Ted

 

--

Theodore (Ted) Heise, PHD, RAC

Vice President Regulatory and Clinical Services

 

MED Institute Inc.

1330 Win Hentschel Blvd.

West Lafayette, IN  47906-4149 USA

765.463.1633 ext. 4444

http://medinstitute.com

theise@medinstitute.com

 

 

 

 

 

Original Message------

Good day,

Preparing for a Q-Submission meeting is important whether face-to-face or teleconference.  Keep in mind you probably only have 1 hour to discuss your Q-Submission request, so yes you can have a Powerpoint presentation or introduction to the product but should be limited to 5 - 10 minutes.  The presentation should be sent to FDA in advance, since many of their participates only dial in on phone, but at least they can scroll through the presentation.  Video, would stay away from that - if you send a video just have this for the FDA persons own availability to view in advance.  Consider it is audio only, again some participants from FDA may be calling in my an office or home where they can not share a screen.  You have to be flexible when going into a Q-Submission meeting - but definitely put an agenda together for the different topics, e.g. 5 min introduction, 5 min product review, 5 min presentation, 10 min present current regulatory needs, then 30 minutes for review of questions.  The FDA will read your Q-Submission request with areas of feedback and provide a written response about 5 days in advance of the meeting.  In this way the actual teleconference should be review of any "sticky" or difficult points that are still not clear.  As an example, the Q-Submission feedback says we will have 50 patients, FDA responds acceptable in writing.  Do not need to cover in the meeting.  In the Q-Sub feedback there is a question about a specific performance test, FDA responds with some information, but maybe you need more clarification - this should be covered in the teleconference.  Roles should be the main contact and person managing the meeting (FDA does not manage the meeting - or should not manage - it should be managed by the company), someone to take notes because you need to write meeting minutes, and then an SME or two.  You can have as many people on the phone, but only 1 or 2 people should speak because it can get confusing with multiple people talking.  Also a good hint, whenever you start talking state your name so FDA knows who is actually talking.  I send the draft meeting minutes to the reviewer through email, but the "official" meeting meetings need to be sent in eCopy version to the DCC address.  There are lots and lots of other tips, but could probably write a 10 page white paper on this !

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message------

This message was posted by a user wishing to remain anonymous

Thank you both for your help. 
Regarding the following point in the FDA guidance:
"Submitters that request a meeting should be aware that all meetings are subject to disclosure review pursuant to the Freedom of Information Act (FOIA)."
Do you recommend to include a statement at the beginning of the presentation to request confidentiality and nondisclosure of the meeting information?
Thanks again

Thank you Richard for clarifying that. i was going to say that if FDA responds that what you propose is acceptable, then you need to allocate the time to those where FDA has additional questions. Has it ever happen to you that FDA agrees with all the proposed approaches? I am asking this because I believe that questions should the result of a very thorough homework, and that the context presented for each question shows that we have tried a few options and we ask if FDA agrees with our approach based on the rationale presented (at least for pre-IND meetings). 
I look forward to reading your 10 page white paper on pre-IND meetings!!!!
---------------------------------------------

------------------------------
Liliana Chocarro
Consultant
MISSISSAUGA ON
Canada
------------------------------

Original Message:
Sent: 17-Apr-2020 04:28
From: Richard Vincins
Subject: prepare pre-sub teleconference

Good day,

Preparing for a Q-Submission meeting is important whether face-to-face or teleconference.  Keep in mind you probably only have 1 hour to discuss your Q-Submission request, so yes you can have a Powerpoint presentation or introduction to the product but should be limited to 5 - 10 minutes.  The presentation should be sent to FDA in advance, since many of their participates only dial in on phone, but at least they can scroll through the presentation.  Video, would stay away from that - if you send a video just have this for the FDA persons own availability to view in advance.  Consider it is audio only, again some participants from FDA may be calling in my an office or home where they can not share a screen.  You have to be flexible when going into a Q-Submission meeting - but definitely put an agenda together for the different topics, e.g. 5 min introduction, 5 min product review, 5 min presentation, 10 min present current regulatory needs, then 30 minutes for review of questions.  The FDA will read your Q-Submission request with areas of feedback and provide a written response about 5 days in advance of the meeting.  In this way the actual teleconference should be review of any "sticky" or difficult points that are still not clear.  As an example, the Q-Submission feedback says we will have 50 patients, FDA responds acceptable in writing.  Do not need to cover in the meeting.  In the Q-Sub feedback there is a question about a specific performance test, FDA responds with some information, but maybe you need more clarification - this should be covered in the teleconference.  Roles should be the main contact and person managing the meeting (FDA does not manage the meeting - or should not manage - it should be managed by the company), someone to take notes because you need to write meeting minutes, and then an SME or two.  You can have as many people on the phone, but only 1 or 2 people should speak because it can get confusing with multiple people talking.  Also a good hint, whenever you start talking state your name so FDA knows who is actually talking.  I send the draft meeting minutes to the reviewer through email, but the "official" meeting meetings need to be sent in eCopy version to the DCC address.  There are lots and lots of other tips, but could probably write a 10 page white paper on this !

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 16-Apr-2020 09:54
From: Anonymous Member
Subject: prepare pre-sub teleconference

This message was posted by a user wishing to remain anonymous

Hi forum,
I am looking for tips and reference readings for the preparation of our Q-sub (pre-submission) meeting. It is our first interaction with the FDA and it was supposed to be in person, but it got converted into a teleconference due to the current situation.
Some points that I have in mind are the following:
- Structure of the Powerpoint presentation. Is it better to have some introductory slides (or videos) on the device (however, the reviewer has already read the pre-submission + I guess this is more in the scope of informational meetings, not pre-subs) or go directly to the responses to their feedback? How many slides?
- Suggestions on the best way to prepare for the meeting (and the responses to the feedback) while waiting for the written feedback?
- Should the presentation be sent in advance to the FDA? How long in advance?
- Can you confirm that the teleconference will be audio only (+ share screen for the presentation)?
- Suggestion on how logistically tackle the challenge of the very limited time (5 days) to prepare/respond? Are these 5 working days?
- Roles? Should one single person (e.g., RA?) present it all or should each team expert address his/her specific topic/question?
- Suggestions on behavior best practices to share with the team?
- Can the meeting minutes be sent to the FDA by email or should they be physically mailed under the e-Copy program?
- Any other tip/point I am missing?
Thanks for any suggestion or reference you can provide.

This message was posted by a user wishing to remain anonymous

I never do Powerpoints or any type of presentation since the goal of the meeting is to gain clarification on the questions you posed to FDA. They've already reviewed your [hopefully comprehensive] package and prepared answers, so you want to spend every precious minute gaining clarification on what you need to do. So I would neither recommend a presentation nor sending any slides beforehand.

What I prepare is a possible FDA response(s) for each question asked, the relevant section of the briefing package, who on the team should respond, and what clarifying questions they should ask and/or attempt to defend.

This changes if they provide preliminary written feedback. In that case, providing something in writing to them before the meeting would be beneficial to guide the discussion.
Original Message:
Sent: 16-Apr-2020 09:54
From: Anonymous Member
Subject: prepare pre-sub teleconference

This message was posted by a user wishing to remain anonymous

Hi forum,
I am looking for tips and reference readings for the preparation of our Q-sub (pre-submission) meeting. It is our first interaction with the FDA and it was supposed to be in person, but it got converted into a teleconference due to the current situation.
Some points that I have in mind are the following:
- Structure of the Powerpoint presentation. Is it better to have some introductory slides (or videos) on the device (however, the reviewer has already read the pre-submission + I guess this is more in the scope of informational meetings, not pre-subs) or go directly to the responses to their feedback? How many slides?
- Suggestions on the best way to prepare for the meeting (and the responses to the feedback) while waiting for the written feedback?
- Should the presentation be sent in advance to the FDA? How long in advance?
- Can you confirm that the teleconference will be audio only (+ share screen for the presentation)?
- Suggestion on how logistically tackle the challenge of the very limited time (5 days) to prepare/respond? Are these 5 working days?
- Roles? Should one single person (e.g., RA?) present it all or should each team expert address his/her specific topic/question?
- Suggestions on behavior best practices to share with the team?
- Can the meeting minutes be sent to the FDA by email or should they be physically mailed under the e-Copy program?
- Any other tip/point I am missing?
Thanks for any suggestion or reference you can provide.

Haha a White Paper on pre-IND Liliana, I wish had the time to do that !

Actually, yes have had a few instances in the last 20 years where we submitted the feedback request via Q-Submission to FDA with a request for teleconference call.  We did such a good job presenting the information, FDA responded (in their response a couple weeks before the call) with acceptance and/or provided enough feedback we cancelled the call.  There are times if information is presented in a good, complete, detailed manner, the FDA can provide good feedback so need for clarification from a further call may not be necessary.  I can tell you it is a good feeling when we contact the reviewer to say, "Understood, no need for a call."

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 28-Apr-2020 09:33
From: Anonymous Member
Subject: prepare pre-sub teleconference

This message was posted by a user wishing to remain anonymous

I never do Powerpoints or any type of presentation since the goal of the meeting is to gain clarification on the questions you posed to FDA. They've already reviewed your [hopefully comprehensive] package and prepared answers, so you want to spend every precious minute gaining clarification on what you need to do. So I would neither recommend a presentation nor sending any slides beforehand.

What I prepare is a possible FDA response(s) for each question asked, the relevant section of the briefing package, who on the team should respond, and what clarifying questions they should ask and/or attempt to defend.

This changes if they provide preliminary written feedback. In that case, providing something in writing to them before the meeting would be beneficial to guide the discussion.
Original Message:
Sent: 16-Apr-2020 09:54
From: Anonymous Member
Subject: prepare pre-sub teleconference

This message was posted by a user wishing to remain anonymous

Hi forum,
I am looking for tips and reference readings for the preparation of our Q-sub (pre-submission) meeting. It is our first interaction with the FDA and it was supposed to be in person, but it got converted into a teleconference due to the current situation.
Some points that I have in mind are the following:
- Structure of the Powerpoint presentation. Is it better to have some introductory slides (or videos) on the device (however, the reviewer has already read the pre-submission + I guess this is more in the scope of informational meetings, not pre-subs) or go directly to the responses to their feedback? How many slides?
- Suggestions on the best way to prepare for the meeting (and the responses to the feedback) while waiting for the written feedback?
- Should the presentation be sent in advance to the FDA? How long in advance?
- Can you confirm that the teleconference will be audio only (+ share screen for the presentation)?
- Suggestion on how logistically tackle the challenge of the very limited time (5 days) to prepare/respond? Are these 5 working days?
- Roles? Should one single person (e.g., RA?) present it all or should each team expert address his/her specific topic/question?
- Suggestions on behavior best practices to share with the team?
- Can the meeting minutes be sent to the FDA by email or should they be physically mailed under the e-Copy program?
- Any other tip/point I am missing?
Thanks for any suggestion or reference you can provide.

I guess there are different philosophies here. I, for one, always try to achieve multiple things in these meetings, particularly in person meetings. First, of course, are gaining clarity around the questions you submitted. So, yes, you prepare for that partly by brainstorming their "answers" or questions and having planned responses. However, if FDA isn't familiar with the company or device, this is a great chance to show them you truly have experts in what you do, are credible and you can better help them understand the device. If the device is small enough, I always bring samples - every FDA expert I have ever met with loves them and ask great clarifying questions that help down the road. If a big piece of equipment sometimes you have to make do with a brief video or something, but it is super helpful for them to have more understanding when your submission comes along (you'd be surprised how many complete misunderstandings there are of some devices). Additionally, I like to create opportunities (either in Q&A, during a brief presentation or right after the meeting informally) for my experts to talk to FDA's experts. They are much more willing to listen to your opinion if they think it comes from an expert and not a "sales guy" who is only worried about revenue. This building confidence has proven to be useful over and over again.

So my suggestion would be to think about the 2-3 things you'd like to achieve and plan accordingly.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 28-Apr-2020 09:33
From: Anonymous Member
Subject: prepare pre-sub teleconference

This message was posted by a user wishing to remain anonymous

I never do Powerpoints or any type of presentation since the goal of the meeting is to gain clarification on the questions you posed to FDA. They've already reviewed your [hopefully comprehensive] package and prepared answers, so you want to spend every precious minute gaining clarification on what you need to do. So I would neither recommend a presentation nor sending any slides beforehand.

What I prepare is a possible FDA response(s) for each question asked, the relevant section of the briefing package, who on the team should respond, and what clarifying questions they should ask and/or attempt to defend.

This changes if they provide preliminary written feedback. In that case, providing something in writing to them before the meeting would be beneficial to guide the discussion.
Original Message:
Sent: 16-Apr-2020 09:54
From: Anonymous Member
Subject: prepare pre-sub teleconference

This message was posted by a user wishing to remain anonymous

Hi forum,
I am looking for tips and reference readings for the preparation of our Q-sub (pre-submission) meeting. It is our first interaction with the FDA and it was supposed to be in person, but it got converted into a teleconference due to the current situation.
Some points that I have in mind are the following:
- Structure of the Powerpoint presentation. Is it better to have some introductory slides (or videos) on the device (however, the reviewer has already read the pre-submission + I guess this is more in the scope of informational meetings, not pre-subs) or go directly to the responses to their feedback? How many slides?
- Suggestions on the best way to prepare for the meeting (and the responses to the feedback) while waiting for the written feedback?
- Should the presentation be sent in advance to the FDA? How long in advance?
- Can you confirm that the teleconference will be audio only (+ share screen for the presentation)?
- Suggestion on how logistically tackle the challenge of the very limited time (5 days) to prepare/respond? Are these 5 working days?
- Roles? Should one single person (e.g., RA?) present it all or should each team expert address his/her specific topic/question?
- Suggestions on behavior best practices to share with the team?
- Can the meeting minutes be sent to the FDA by email or should they be physically mailed under the e-Copy program?
- Any other tip/point I am missing?
Thanks for any suggestion or reference you can provide.

I like your attitude!  The potential downfall is that the FDAers in the meeting have not, in fact, reviewed your package comprehensively, even though they have prepared answers. Or that they have reviewed it, but didn't understand it, so questions may be off the mark.  Or that they reviewed it, but they have reviewed a lot of other stuff since then, and are now a little fuzzy on the details. 

I gather your experience has been positive in this regard.  What kinds of submissions have you met with FDA in pre- of (IND, IDE, 510(k), PMA, NDA, BLA)?  Therapeutic areas?

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

Original Message:
Sent: 28-Apr-2020 09:33
From: Anonymous Member
Subject: prepare pre-sub teleconference

This message was posted by a user wishing to remain anonymous

I never do Powerpoints or any type of presentation since the goal of the meeting is to gain clarification on the questions you posed to FDA. They've already reviewed your [hopefully comprehensive] package and prepared answers, so you want to spend every precious minute gaining clarification on what you need to do. So I would neither recommend a presentation nor sending any slides beforehand.

What I prepare is a possible FDA response(s) for each question asked, the relevant section of the briefing package, who on the team should respond, and what clarifying questions they should ask and/or attempt to defend.

This changes if they provide preliminary written feedback. In that case, providing something in writing to them before the meeting would be beneficial to guide the discussion.
Original Message:
Sent: 16-Apr-2020 09:54
From: Anonymous Member
Subject: prepare pre-sub teleconference

This message was posted by a user wishing to remain anonymous

Hi forum,
I am looking for tips and reference readings for the preparation of our Q-sub (pre-submission) meeting. It is our first interaction with the FDA and it was supposed to be in person, but it got converted into a teleconference due to the current situation.
Some points that I have in mind are the following:
- Structure of the Powerpoint presentation. Is it better to have some introductory slides (or videos) on the device (however, the reviewer has already read the pre-submission + I guess this is more in the scope of informational meetings, not pre-subs) or go directly to the responses to their feedback? How many slides?
- Suggestions on the best way to prepare for the meeting (and the responses to the feedback) while waiting for the written feedback?
- Should the presentation be sent in advance to the FDA? How long in advance?
- Can you confirm that the teleconference will be audio only (+ share screen for the presentation)?
- Suggestion on how logistically tackle the challenge of the very limited time (5 days) to prepare/respond? Are these 5 working days?
- Roles? Should one single person (e.g., RA?) present it all or should each team expert address his/her specific topic/question?
- Suggestions on behavior best practices to share with the team?
- Can the meeting minutes be sent to the FDA by email or should they be physically mailed under the e-Copy program?
- Any other tip/point I am missing?
Thanks for any suggestion or reference you can provide.