Regulatory Open Forum

Dear Regex,
What are the main functional teams that should exist in an RA department? noting that this RA department centrally serves multiple regions at the same time. 
Your suggestions and real life examples will help a lot.

------------------------------
Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
------------------------------

Hi Alaa,

You don't specify drugs/biologics or devices.  So, I will presume drugs/biologics in my response.

I would start with the basics:

• Regulatory Strategy:  Typically, the staff in this group are the Global (and Regional) Regulatory Leads for the program teams and principally support Clinical and Nonclinical activities.  The staff in this group are also usually the main point of contact with regulatory health authorities.  This is usually the largest group within Regulatory.
• Regulatory CMC:  The staff in this group work closely with the manufacturing, analytical, and Quality Assurance groups; they also serve as a bridge between the CMC and the Clinical arms of the organization.  In a small organization at early stages, this may be outsourced.  About Phase 2, I would hire an internal Reg CMC person.
• Regulatory Operations:  The staff in this group support submission preparation and management, publishing (or coordinating with external publishing CROs, archiving, etc.  In a small organization, this may be 1 person.

Within a year of commercialization, you would also need a Promotion / Advertising / Labeling (PAL) group in Regulatory to work with Marketing/Commercial.

Some Regulatory functions also include Medical Writing &/or Pharmacovigilance, if the organization chooses.

I'm sure others will share their perspectives, as well, so you will get a good cross-section of thoughts.

Good luck!

Mark

------------------------------
Mark De Rosch, PhD, FRAPS
Epizyme, Inc.
Cambridge, MA
United States
------------------------------

Original Message:
Sent: 07-Mar-2021 01:24
From: Alaa El Kazak
Subject: RA (drugs) functional teams

Dear Regex,
What are the main functional teams that should exist in an RA department? noting that this RA department centrally serves multiple regions at the same time.
Your suggestions and real life examples will help a lot.

------------------------------
Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
------------------------------

Dear Mark,
Thanks for your valuable response. Really appreciated. Should the regulatory intelligence activities be handled by the strategy team?

------------------------------
Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
------------------------------

Original Message:
Sent: 08-Mar-2021 07:08
From: Mark De Rosch
Subject: RA (drugs) functional teams

Hi Alaa,

You don't specify drugs/biologics or devices.  So, I will presume drugs/biologics in my response.

I would start with the basics:

• Regulatory Strategy:  Typically, the staff in this group are the Global (and Regional) Regulatory Leads for the program teams and principally support Clinical and Nonclinical activities.  The staff in this group are also usually the main point of contact with regulatory health authorities.  This is usually the largest group within Regulatory.
• Regulatory CMC:  The staff in this group work closely with the manufacturing, analytical, and Quality Assurance groups; they also serve as a bridge between the CMC and the Clinical arms of the organization.  In a small organization at early stages, this may be outsourced.  About Phase 2, I would hire an internal Reg CMC person.
• Regulatory Operations:  The staff in this group support submission preparation and management, publishing (or coordinating with external publishing CROs, archiving, etc.  In a small organization, this may be 1 person.

Within a year of commercialization, you would also need a Promotion / Advertising / Labeling (PAL) group in Regulatory to work with Marketing/Commercial.

Some Regulatory functions also include Medical Writing &/or Pharmacovigilance, if the organization chooses.

I'm sure others will share their perspectives, as well, so you will get a good cross-section of thoughts.

Good luck!

Mark

------------------------------
Mark De Rosch, PhD, FRAPS
Epizyme, Inc.
Cambridge, MA
United States

Original Message:
Sent: 07-Mar-2021 01:24
From: Alaa El Kazak
Subject: RA (drugs) functional teams

Dear Regex,
What are the main functional teams that should exist in an RA department? noting that this RA department centrally serves multiple regions at the same time.
Your suggestions and real life examples will help a lot.

------------------------------
Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
------------------------------

For smaller companies without a specific Regulatory Intelligence group, RI becomes responsibility of everyone in the Regulatory function almost ad hoc.  Though systems such as Clarivate may help systematize collection of RI.  Larger Regulatory groups may have a specific individual(s) who is responsible for collecting search terms, running searches, and disseminating the search results to someone else to assess the impact of the RI on the organization.

------------------------------
Mark A. De Rosch, PhD, FRAPS
Epizyme, Inc.
Cambridge, MA
United States
------------------------------

Original Message:
Sent: 08-Mar-2021 14:45
From: Alaa El Kazak
Subject: RA (drugs) functional teams

Dear Mark,
Thanks for your valuable response. Really appreciated. Should the regulatory intelligence activities be handled by the strategy team?

------------------------------
Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk

Original Message:
Sent: 08-Mar-2021 07:08
From: Mark De Rosch
Subject: RA (drugs) functional teams

Hi Alaa,

You don't specify drugs/biologics or devices.  So, I will presume drugs/biologics in my response.

I would start with the basics:

• Regulatory Strategy:  Typically, the staff in this group are the Global (and Regional) Regulatory Leads for the program teams and principally support Clinical and Nonclinical activities.  The staff in this group are also usually the main point of contact with regulatory health authorities.  This is usually the largest group within Regulatory.
• Regulatory CMC:  The staff in this group work closely with the manufacturing, analytical, and Quality Assurance groups; they also serve as a bridge between the CMC and the Clinical arms of the organization.  In a small organization at early stages, this may be outsourced.  About Phase 2, I would hire an internal Reg CMC person.
• Regulatory Operations:  The staff in this group support submission preparation and management, publishing (or coordinating with external publishing CROs, archiving, etc.  In a small organization, this may be 1 person.

Within a year of commercialization, you would also need a Promotion / Advertising / Labeling (PAL) group in Regulatory to work with Marketing/Commercial.

Some Regulatory functions also include Medical Writing &/or Pharmacovigilance, if the organization chooses.

I'm sure others will share their perspectives, as well, so you will get a good cross-section of thoughts.

Good luck!

Mark

------------------------------
Mark De Rosch, PhD, FRAPS
Epizyme, Inc.
Cambridge, MA
United States

Original Message:
Sent: 07-Mar-2021 01:24
From: Alaa El Kazak
Subject: RA (drugs) functional teams

Dear Regex,
What are the main functional teams that should exist in an RA department? noting that this RA department centrally serves multiple regions at the same time.
Your suggestions and real life examples will help a lot.

------------------------------
Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Alaa, 

Main function teams within RA include a Regulatory Strategy group, CMC and Regulatory Operations. If you are a big company, you can have other groups like Regional Regulatory Strategy groups like EU, Japan, RoW, Regulatory Intelligence, Regulatory Biomarkers and Companion Diagnostics, Regulatory Labeling. 

Hope this is helpful.
Original Message:
Sent: 07-Mar-2021 01:24
From: Alaa El Kazak
Subject: RA (drugs) functional teams

Dear Regex,
What are the main functional teams that should exist in an RA department? noting that this RA department centrally serves multiple regions at the same time.
Your suggestions and real life examples will help a lot.

------------------------------
Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
------------------------------

Dear, 
Thanks for the valuable input. Really appreciated. It's matching with Mark's above response.

------------------------------
Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
------------------------------

Original Message:
Sent: 07-Mar-2021 14:28
From: Anonymous Member
Subject: RA (drugs) functional teams

This message was posted by a user wishing to remain anonymous

Hi Alaa,

Main function teams within RA include a Regulatory Strategy group, CMC and Regulatory Operations. If you are a big company, you can have other groups like Regional Regulatory Strategy groups like EU, Japan, RoW, Regulatory Intelligence, Regulatory Biomarkers and Companion Diagnostics, Regulatory Labeling.

Hope this is helpful.
Original Message:
Sent: 07-Mar-2021 01:24
From: Alaa El Kazak
Subject: RA (drugs) functional teams

Dear Regex,
What are the main functional teams that should exist in an RA department? noting that this RA department centrally serves multiple regions at the same time.
Your suggestions and real life examples will help a lot.

------------------------------
Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
------------------------------