Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I work for a small company as an Regulatory Affairs Manager and I will be attending trade shows that promote our products.  I know this is common thing for RA professionals but I'm not sure what I'm supposed to be doing the entire time.  Am I just waiting for an FDA rep to come to start asking me about our approvals?  Please let me know if any of you have advice as to how to fill my time at these events.  Thank you in advance.

This message was posted by a user wishing to remain anonymous

I am assuming you were/are involved in the review of the promotional exhibit booth? If so... Prior to opening the exhibit hall to the public, you can be there to work with marketing and the events team/creative agnecy to ensure the promotional exhibit booth was constructed in a way that matches the renderings you approved (for example, ensuring chairs are not blocking safety information,  confirming prescribing information has been appropriately placed in literature racks). perhaps you can attend a pre-conference training with the booth staff to review compliance guidelines, reminders, and what to do if they get an off-label question.

Making sure the booth staff has your contact information is great so if FDA was to stop by, you can be contacted immediately. I do not usually "linger" around waiting for this to happen, but I want to be easily reachable to debrief the interaction and to address any follow-up or documentation. 

Once the conference is active, it's a great opportunity to walk the exhibit hall and get a view into what other companies are doing in their booths. Sometimes I will schedule an opportunity to take a walk with someone from Marketing so you can get a view into what piques their interest for future booths and to identify what may pose Regulatory review challenges. You can talk to marketing about other meetings they might allow you to join - it's a great time to be a fly on the wall/observe so you can help your team build in the right promotional safeguards at future events.

Attending any of the scientific presentations that are relevant to your company can be beneficial in understanding the disease and treatment landscape. Perhaps attending this with someone from your medical team is helpful to put any topics into perspective. 

There may be a good amount of time where you are on your own - finding a quiet place to answer some emails or catch up on work. I often do not stay for the whole conference unless we are doing a lot of promotional activities (ie, multiple sponsorship symposia and dinner programs/sponsoring events like a 5k, etc.). two days is usually sufficient to be there for the booth opening and initial training.

With any luck, FDA won't step foot in your booth! I've only had an agency visitor once, and it wasn't for any particular reason - a question unrelated to our conference presence. 

Best of luck!
Original Message:
Sent: 11-Mar-2022 14:34
From: Anonymous Member
Subject: Regulatory Role at Trade Show

This message was posted by a user wishing to remain anonymous

I work for a small company as an Regulatory Affairs Manager and I will be attending trade shows that promote our products.  I know this is common thing for RA professionals but I'm not sure what I'm supposed to be doing the entire time.  Am I just waiting for an FDA rep to come to start asking me about our approvals?  Please let me know if any of you have advice as to how to fill my time at these events.  Thank you in advance.

This message was posted by a user wishing to remain anonymous

This is extremely helpful!  Thank you for sharing all of that!
Original Message:
Sent: 14-Mar-2022 14:05
From: Anonymous Member
Subject: Regulatory Role at Trade Show

This message was posted by a user wishing to remain anonymous

I am assuming you were/are involved in the review of the promotional exhibit booth? If so... Prior to opening the exhibit hall to the public, you can be there to work with marketing and the events team/creative agnecy to ensure the promotional exhibit booth was constructed in a way that matches the renderings you approved (for example, ensuring chairs are not blocking safety information,  confirming prescribing information has been appropriately placed in literature racks). perhaps you can attend a pre-conference training with the booth staff to review compliance guidelines, reminders, and what to do if they get an off-label question.

Making sure the booth staff has your contact information is great so if FDA was to stop by, you can be contacted immediately. I do not usually "linger" around waiting for this to happen, but I want to be easily reachable to debrief the interaction and to address any follow-up or documentation.

Once the conference is active, it's a great opportunity to walk the exhibit hall and get a view into what other companies are doing in their booths. Sometimes I will schedule an opportunity to take a walk with someone from Marketing so you can get a view into what piques their interest for future booths and to identify what may pose Regulatory review challenges. You can talk to marketing about other meetings they might allow you to join - it's a great time to be a fly on the wall/observe so you can help your team build in the right promotional safeguards at future events.

Attending any of the scientific presentations that are relevant to your company can be beneficial in understanding the disease and treatment landscape. Perhaps attending this with someone from your medical team is helpful to put any topics into perspective.

There may be a good amount of time where you are on your own - finding a quiet place to answer some emails or catch up on work. I often do not stay for the whole conference unless we are doing a lot of promotional activities (ie, multiple sponsorship symposia and dinner programs/sponsoring events like a 5k, etc.). two days is usually sufficient to be there for the booth opening and initial training.

With any luck, FDA won't step foot in your booth! I've only had an agency visitor once, and it wasn't for any particular reason - a question unrelated to our conference presence.

Best of luck!
Original Message:
Sent: 11-Mar-2022 14:34
From: Anonymous Member
Subject: Regulatory Role at Trade Show

This message was posted by a user wishing to remain anonymous

I work for a small company as an Regulatory Affairs Manager and I will be attending trade shows that promote our products.  I know this is common thing for RA professionals but I'm not sure what I'm supposed to be doing the entire time.  Am I just waiting for an FDA rep to come to start asking me about our approvals?  Please let me know if any of you have advice as to how to fill my time at these events.  Thank you in advance.

The initial response is on target - but there are additional questions you need to ask yourself to make the most of your experience.  Is the booth a medical device or drug/biologic booth?  Promotional considerations are substantially different but the common ground is that you should be promoting consistent with your label.  Another question - what is your role in the Regulatory Dept?  If you are, for example, working mainly on submissions or in CMC, you may not have responsibilities for the booth content, nor knowledge of the promotional regulatory considerations.  In this instance, I would spend time with your manager preparing for this conference/show to plan the purpose of your attendance.  Sometimes it is to gain knowledge about the topics/sessions at the show and/or the competitive products out there.  That is very different and could potentially mean you take off your regulatory hat during your attendance and just be there as a sponge to absorb information!

Your company should have a plan for if an FDA staffer comes by your booth, but in my experience over the years, it is infrequent.  Nevertheless, the preparation or procedure should be in place so that your company representatives (of all functions) know what to do.

Enjoy the conference!

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
Chair, RAPS Board of Directors
United States
------------------------------

Original Message:
Sent: 11-Mar-2022 14:34
From: Anonymous Member
Subject: Regulatory Role at Trade Show

This message was posted by a user wishing to remain anonymous

I work for a small company as an Regulatory Affairs Manager and I will be attending trade shows that promote our products.  I know this is common thing for RA professionals but I'm not sure what I'm supposed to be doing the entire time.  Am I just waiting for an FDA rep to come to start asking me about our approvals?  Please let me know if any of you have advice as to how to fill my time at these events.  Thank you in advance.

This message was posted by a user wishing to remain anonymous

At our company we invite the FDA reviewers to tour our booth.  The RA people lead this tour.

As a former FDA staffer who did visit booths, I visited just to get a feel for the devices I reviewed that a 10,000 page B&W PDF could not generally provide, and also sometimes in hopes of attaching a face to the name on that 10,000 page PDF.

When companies were friendly, treated me like a customer to be educated, and didn't view my visit as "ZOMG the FDA is here--the sky is falling," it was great and I really appreciated it.
Original Message:
Sent: 15-Mar-2022 09:56
From: Glenn Byrd
Subject: Regulatory Role at Trade Show

The initial response is on target - but there are additional questions you need to ask yourself to make the most of your experience.  Is the booth a medical device or drug/biologic booth?  Promotional considerations are substantially different but the common ground is that you should be promoting consistent with your label.  Another question - what is your role in the Regulatory Dept?  If you are, for example, working mainly on submissions or in CMC, you may not have responsibilities for the booth content, nor knowledge of the promotional regulatory considerations.  In this instance, I would spend time with your manager preparing for this conference/show to plan the purpose of your attendance.  Sometimes it is to gain knowledge about the topics/sessions at the show and/or the competitive products out there.  That is very different and could potentially mean you take off your regulatory hat during your attendance and just be there as a sponge to absorb information!

Your company should have a plan for if an FDA staffer comes by your booth, but in my experience over the years, it is infrequent.  Nevertheless, the preparation or procedure should be in place so that your company representatives (of all functions) know what to do.

Enjoy the conference!

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
Chair, RAPS Board of Directors
United States

Original Message:
Sent: 11-Mar-2022 14:34
From: Anonymous Member
Subject: Regulatory Role at Trade Show

This message was posted by a user wishing to remain anonymous

I work for a small company as an Regulatory Affairs Manager and I will be attending trade shows that promote our products.  I know this is common thing for RA professionals but I'm not sure what I'm supposed to be doing the entire time.  Am I just waiting for an FDA rep to come to start asking me about our approvals?  Please let me know if any of you have advice as to how to fill my time at these events.  Thank you in advance.