Regulatory Open Forum

Hello All,

I have a (hopefully simple) question regarding a Regulatory Affairs Lead's role on a Publication Committee. Other than ensuring that (1) the data being used in the research and (2) the research questions being addressed in the manuscript were approved by an IRB prior to conducting the research, what other responsibilities or services might a Reg Affairs stakeholder be in charge of within the committee?

To give some perspective, the studies where data is collected from may be device or drug-device combination studies that were submitted to regulatory agencies, such as the FDA.

Thank you!

------------------------------
Brendan Watson
Clinical Trials Associate
------------------------------

My primary focus on a publication review committee is to make sure that there are no inappropriate statements that could be considered promotional, either pre-market or off-label. If the data is generated by the company, Regulatory Affairs should already be well satisfied that any clinical study was approved by an IRB before it ever gets to the point of submission or publication.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 03-Mar-2020 20:26
From: Brendan Watson
Subject: Publication Committee Regulatory Stakeholder

Hello All,

I have a (hopefully simple) question regarding a Regulatory Affairs Lead's role on a Publication Committee. Other than ensuring that (1) the data being used in the research and (2) the research questions being addressed in the manuscript were approved by an IRB prior to conducting the research, what other responsibilities or services might a Reg Affairs stakeholder be in charge of within the committee?

To give some perspective, the studies where data is collected from may be device or drug-device combination studies that were submitted to regulatory agencies, such as the FDA.

Thank you!

------------------------------
Brendan Watson
Clinical Trials Associate
------------------------------

Thank you for your response!

------------------------------
Brendan Watson
Clinical Trials Associate
------------------------------

Original Message:
Sent: 04-Mar-2020 08:22
From: Glen Park
Subject: Publication Committee Regulatory Stakeholder

My primary focus on a publication review committee is to make sure that there are no inappropriate statements that could be considered promotional, either pre-market or off-label. If the data is generated by the company, Regulatory Affairs should already be well satisfied that any clinical study was approved by an IRB before it ever gets to the point of submission or publication.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 03-Mar-2020 20:26
From: Brendan Watson
Subject: Publication Committee Regulatory Stakeholder

Hello All,

I have a (hopefully simple) question regarding a Regulatory Affairs Lead's role on a Publication Committee. Other than ensuring that (1) the data being used in the research and (2) the research questions being addressed in the manuscript were approved by an IRB prior to conducting the research, what other responsibilities or services might a Reg Affairs stakeholder be in charge of within the committee?

To give some perspective, the studies where data is collected from may be device or drug-device combination studies that were submitted to regulatory agencies, such as the FDA.

Thank you!

------------------------------
Brendan Watson
Clinical Trials Associate
------------------------------

I also think it's important for RA to be part of the dialogue regarding data integrity, especially for publications involving post-marketing and or investigator initiated work.

------------------------------
David Mason
Chief Medical Officer
Marietta GA
United States
------------------------------

Original Message:
Sent: 03-Mar-2020 20:26
From: Brendan Watson
Subject: Publication Committee Regulatory Stakeholder

Hello All,

I have a (hopefully simple) question regarding a Regulatory Affairs Lead's role on a Publication Committee. Other than ensuring that (1) the data being used in the research and (2) the research questions being addressed in the manuscript were approved by an IRB prior to conducting the research, what other responsibilities or services might a Reg Affairs stakeholder be in charge of within the committee?

To give some perspective, the studies where data is collected from may be device or drug-device combination studies that were submitted to regulatory agencies, such as the FDA.

Thank you!

------------------------------
Brendan Watson
Clinical Trials Associate
------------------------------

Thank you!

------------------------------
Brendan Watson
Clinical Trials Associate
------------------------------

Original Message:
Sent: 04-Mar-2020 09:17
From: David Mason
Subject: Publication Committee Regulatory Stakeholder

I also think it's important for RA to be part of the dialogue regarding data integrity, especially for publications involving post-marketing and or investigator initiated work.

------------------------------
David Mason
Chief Medical Officer
Marietta GA
United States

Original Message:
Sent: 03-Mar-2020 20:26
From: Brendan Watson
Subject: Publication Committee Regulatory Stakeholder

Hello All,

I have a (hopefully simple) question regarding a Regulatory Affairs Lead's role on a Publication Committee. Other than ensuring that (1) the data being used in the research and (2) the research questions being addressed in the manuscript were approved by an IRB prior to conducting the research, what other responsibilities or services might a Reg Affairs stakeholder be in charge of within the committee?

To give some perspective, the studies where data is collected from may be device or drug-device combination studies that were submitted to regulatory agencies, such as the FDA.

Thank you!

------------------------------
Brendan Watson
Clinical Trials Associate
------------------------------

If the article might ever be used for promotion, it should stick to the facts of the study and should not include a lot of extras, including off-label suggestions or comparative claims that aren't supported by strong data/labeling.  There are provisions for disclosing scientific data that are not entirely consistent with labeling, but that seems beyond the scope of your (hopefully simple) question!

------------------------------
Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States
------------------------------

Original Message:
Sent: 03-Mar-2020 20:26
From: Brendan Watson
Subject: Publication Committee Regulatory Stakeholder

Hello All,

I have a (hopefully simple) question regarding a Regulatory Affairs Lead's role on a Publication Committee. Other than ensuring that (1) the data being used in the research and (2) the research questions being addressed in the manuscript were approved by an IRB prior to conducting the research, what other responsibilities or services might a Reg Affairs stakeholder be in charge of within the committee?

To give some perspective, the studies where data is collected from may be device or drug-device combination studies that were submitted to regulatory agencies, such as the FDA.

Thank you!

------------------------------
Brendan Watson
Clinical Trials Associate
------------------------------

Thank you, Beth!

------------------------------
Brendan Watson
Clinical Trials Associate
------------------------------

Original Message:
Sent: 04-Mar-2020 10:23
From: Beth Weinberg
Subject: Publication Committee Regulatory Stakeholder

If the article might ever be used for promotion, it should stick to the facts of the study and should not include a lot of extras, including off-label suggestions or comparative claims that aren't supported by strong data/labeling.  There are provisions for disclosing scientific data that are not entirely consistent with labeling, but that seems beyond the scope of your (hopefully simple) question!

------------------------------
Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States

Original Message:
Sent: 03-Mar-2020 20:26
From: Brendan Watson
Subject: Publication Committee Regulatory Stakeholder

Hello All,

I have a (hopefully simple) question regarding a Regulatory Affairs Lead's role on a Publication Committee. Other than ensuring that (1) the data being used in the research and (2) the research questions being addressed in the manuscript were approved by an IRB prior to conducting the research, what other responsibilities or services might a Reg Affairs stakeholder be in charge of within the committee?

To give some perspective, the studies where data is collected from may be device or drug-device combination studies that were submitted to regulatory agencies, such as the FDA.

Thank you!

------------------------------
Brendan Watson
Clinical Trials Associate
------------------------------