Regulatory Open Forum

How do other companies manage or oversee FDA requested Post-Marketing Commitments (PMC) or Post-Marketing Requirements (PMR)?
Is this done in-house or outsourced to vendors? How successful was this?
What are some of the pros and cons?
What role does the Regulatory group play from the sponsoring company which was assigned the original PMC or PMR?
Thanks for your input. Regards.

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A. Rampersaud
Consultant
Eli Lilly And Company
Indianapolis IN
United States
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Dear Ashraff, My experience with PMC/PMC has been managed internally by the RA function for post marketing maintenance that would track PMC/PMC along with the standard annual reports, post marketing surveillance, etc. It was important to transfer knowledge from the preapproval group to the post approval group. How this is managed would depend on the size of an organization and how they are organized. I have never used external resources to manage these requests but would imagine it can be done. The key with either scenario is to thoroughly understand the PMC/PMR including timelines and any background discussions that resulted in the commitment. I would also weigh the cost of internal vs. external vs. the commitment and experience with the specific area. I would propose that ultimately the sponsor's RA group is responsible for any PMC/PMR regardless whether or not it is managed internally or externally as it part of the regulatory action on a regulatory filing. Is there a specific scenario you have in mind. I am sure others will weigh in with different experiences. Dar ------------------------------------------- Darlene Rosario RAC Principal Consultant RA, Quality and Compliance Velocity Consulting Ventura CA United States -------------------------------------------
Original Message: Sent: 11-14-2014 09:40 From: Ashraff Rampersaud Subject: Managing FDA PMC/PMR How do other companies manage or oversee FDA requested Post-Marketing Commitments (PMC) or Post-Marketing Requirements (PMR)? Is this done in-house or outsourced to vendors? How successful was this? What are some of the pros and cons? What role does the Regulatory group play from the sponsoring company which was assigned the original PMC or PMR? Thanks for your input. Regards. ------------------------------------------- A. Rampersaud Consultant Eli Lilly And Company Indianapolis IN United States -------------------------------------------

Hi Darlene,
Thank you for responding and I appreciate hearing your insight based upon personal experience.

I agree that keeping the managment of PMC/PMR in house makes sense. Outsourcing this work may be problematic.

Are the RA resources dedicated to doing  PMC/PMR only and if so, where do you achieve cost-savings in this model? I have thought that a small core cross-functional group of individuals dedicated to a portfolio of compounds within a TA makes sense.

Your thoughts on this?

Ash

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Ashraff Rampersaud
Consultant
Eli Lilly And Company
Indianapolis IN
United States
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Original Message:
Sent: 11-17-2014 10:09
From: Darlene Rosario
Subject: Managing FDA PMC/PMR

Dear Ashraff,

My experience with PMC/PMC has been managed internally by the RA function for post marketing maintenance that would track PMC/PMC along with the standard annual reports, post marketing surveillance, etc. It was important to transfer knowledge from the preapproval group to the post approval group. How this is managed would depend on the size of an organization and how they are organized. I have never used external resources to manage these requests but would imagine it can be done. The key with either scenario is to thoroughly understand the PMC/PMR including timelines and any background discussions that resulted in the commitment. I would also weigh the cost of internal vs. external vs. the commitment and experience with the specific area.

I would propose that ultimately the sponsor's RA group is responsible for any PMC/PMR regardless whether or not it is managed internally or externally as it part of the regulatory action on a regulatory filing.

Is there a specific scenario you have in mind. I am sure others will weigh in with different experiences.

Dar

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Darlene Rosario RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
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