Regulatory Open Forum

I know it could be a very silly question but I really want to clear my head with this doubt. 

What is a role of regulatory affair body in an organisation? How is there work or responsibility differ from QA authorities?

To ensure that their companies comply with all of the regulations and laws concerning their business.Quality assurance  help to prevent mistakes or defects in manufactured products.

I know it could be a very silly question but I really want to clear my head with this doubt. 

What is a role of regulatory affair body in an organisation? How is there work or responsibility differ from QA authorities?

Hi Kadali.

I usually start all of these responses the same way - I hate it but "It all depends".  Honestly the role of the regulatory team in any organization is typically particular to that organization.  I have been in regulatory in 3 different companies in my career and the roles and responsibilities of the department were different in each group. 

The key is that both Quality and Regulatory need to understand what their respective responsibilities are and respect the roles and responsibilities of the other team.  I can state that generally speaking regulatory roles tend to be "prior" to product commercial launch (working through filings, negotiating allowed claims, negotiating the potential labeling, etc.) while the quality roles tended to be more post-market launch (testing, proof of GMP, handling the inspections, etc.).  While I know that this is really not the answer you were likely seeking, unfortunately this is what I have actually seen in the industry.

I know it could be a very silly question but I really want to clear my head with this doubt. 

What is a role of regulatory affair body in an organisation? How is there work or responsibility differ from QA authorities?

I know it could be a very silly question but I really want to clear my head with this doubt. 

What is a role of regulatory affair body in an organisation? How is there work or responsibility differ from QA authorities?

Hi Kadali,

I would agree with what Victor said about regulatory being "pre-market". I've also seen Regulatory handle all FDA/Notified body reporting requirements, whereas quality was in charge of the quality system maintenance and CAPA functions.

I hope that helps.

Best,

I know it could be a very silly question but I really want to clear my head with this doubt. 

What is a role of regulatory affair body in an organisation? How is there work or responsibility differ from QA authorities?

Hi Kadali,

I would agree with what Victor said about regulatory being "pre-market". I've also seen Regulatory handle all FDA/Notified body reporting requirements, whereas quality was in charge of the quality system maintenance and CAPA functions.

I hope that helps.

Best,

I know it could be a very silly question but I really want to clear my head with this doubt. 

What is a role of regulatory affair body in an organisation? How is there work or responsibility differ from QA authorities?

I know it could be a very silly question but I really want to clear my head with this doubt. 

What is a role of regulatory affair body in an organisation? How is there work or responsibility differ from QA authorities?

I know it could be a very silly question but I really want to clear my head with this doubt. 

What is a role of regulatory affair body in an organisation? How is there work or responsibility differ from QA authorities?

I've worked from cradle to commercialization (not to grave yet :)) of a lot of product having worked in start-ups and small companies.  I've also had an opportunity, being an engineer, to have started from manufacturing before having moved horizontally in my career from there with regards to medical devices - going to quality then to regulatory (numerous titles and positions in between under the same umbrella!). 

I can tell you I agree with Ginger, Julie, and Andrea in these posts.  Having worked as dual most of the time (RA & QA), I had to teach a lot of colleagues in the industry as to what I am doing is either QA or RA function.  RA just as QA should be there from the beginning of product development.  A seasoned start-up founder or seasoned start up R&D Engineer, knows this and one of the very first persons they hire or talk to. A regulatory professional helps map out the product from cradle to commercialization.  I learned this talking to a few CEOs and a few first engineers in start-ups.  They understand the business and the need for experienced voice in creating a strategy for the product.  Trust me when I say, even after approvals/clearances, these folks still need RA and expect RA to help them keep up with the global requirements that the company has to meet in order to continue selling the product.

I've always believed in making things as "easy" as possible.  In regards of Julie's apt description that just because an RA is doing some QA task doesn't mean that all of a sudden that task becomes an RA function.  That's even more apparent in start-ups or small companies that have to make do with the minimal resources they have.  Here's a list, NOT INCLUSIVE, of tasks or responsibilities attributed to RA and QA:

Quality Assurance:

• Quality Assurance or Quality Engineering (root cause investigations, contributor in risk assessments, etc.)
• Document Control (if FDA or a regulatory body ever wants to look at that type of document, Document Control should have it)
• Product quality
• 'manufacturing process quality' support (as a former manufacturing engineer, I've needed quality's voice/support in figuring out how to tackle some issues)
• Determination of the need to bring in RA into the discussion regarding product/process issues
• Management Reviews
• Supplier auditing
• Internal auditing
• Quality System management (relevant procedures should be created using ALL departments project managed by Quality)
• Relevant Quality System procedures/processes Training
• Review of product and quality related standards and/or guidances
• Complaint management
• CAPA management
• and more...

Regulatory Affairs:

• Regulatory body submissions (510(k), technical file, PMA, CE Marking, etc.) - pre-market
• Annual Reports to regulatory bodies - postmarket
• Internal auditing support  (with global initiatives now being implemented, QA can't deal with this on their own, RA needs to pay attention and support QA) - pre & postmarket
• Review of advertisement and promotion pieces - postmarket
• Review of ALL applicable revised or new standards and/or guidances from regulatory bodies - pre & postmarket
• Determination of complaint reportability to regulatory bodies - postmarket
• Creation of regulatory-based Quality System procedures - premarket
• Clinical trial submissions (pre & postmarket)
• Risk Assessment contributor (pre & postmarket)
• and more...

Regulatory body auditing/inspection --> RA & QA shared responsibility

Some folks may disagree with me on this last one but I think this particular responsibility has changed from QA to now include RA in a lot of cases because of MDSAP and other global initiatives like clinical evaluation report needs.  QA can't handle this alone considering the QA scope is limited primarily with regulatory compliance.  RA has to really understand some of the work QA does on top of everything else (this is why a lot of companies now see the need for executive level RA&QA person or Compliance person. This person becomes the face, the management representative, who understands everything the whole organization does sometimes understand even accounting practices (Open Payments anyone?). Some of them, thankfully, finally realizes this is not a token position.

I hope that helps,

I know it could be a very silly question but I really want to clear my head with this doubt. 

What is a role of regulatory affair body in an organisation? How is there work or responsibility differ from QA authorities?

Very good comprehensive response Clarisa! I agree with your perspective - makes sense to me! At the end of the day, each organization big or small organize their functions to protect the patients, protect the business and to partner in making the company successful!

Nicole

I've worked from cradle to commercialization (not to grave yet :)) of a lot of product having worked in start-ups and small companies.  I've also had an opportunity, being an engineer, to have started from manufacturing before having moved horizontally in my career from there with regards to medical devices - going to quality then to regulatory (numerous titles and positions in between under the same umbrella!). 

I can tell you I agree with Ginger, Julie, and Andrea in these posts.  Having worked as dual most of the time (RA & QA), I had to teach a lot of colleagues in the industry as to what I am doing is either QA or RA function.  RA just as QA should be there from the beginning of product development.  A seasoned start-up founder or seasoned start up R&D Engineer, knows this and one of the very first persons they hire or talk to. A regulatory professional helps map out the product from cradle to commercialization.  I learned this talking to a few CEOs and a few first engineers in start-ups.  They understand the business and the need for experienced voice in creating a strategy for the product.  Trust me when I say, even after approvals/clearances, these folks still need RA and expect RA to help them keep up with the global requirements that the company has to meet in order to continue selling the product.

I've always believed in making things as "easy" as possible.  In regards of Julie's apt description that just because an RA is doing some QA task doesn't mean that all of a sudden that task becomes an RA function.  That's even more apparent in start-ups or small companies that have to make do with the minimal resources they have.  Here's a list, NOT INCLUSIVE, of tasks or responsibilities attributed to RA and QA:

Quality Assurance:

• Quality Assurance or Quality Engineering (root cause investigations, contributor in risk assessments, etc.)
• Document Control (if FDA or a regulatory body ever wants to look at that type of document, Document Control should have it)
• Product quality
• 'manufacturing process quality' support (as a former manufacturing engineer, I've needed quality's voice/support in figuring out how to tackle some issues)
• Determination of the need to bring in RA into the discussion regarding product/process issues
• Management Reviews
• Supplier auditing
• Internal auditing
• Quality System management (relevant procedures should be created using ALL departments project managed by Quality)
• Relevant Quality System procedures/processes Training
• Review of product and quality related standards and/or guidances
• Complaint management
• CAPA management
• and more...

Regulatory Affairs:

• Regulatory body submissions (510(k), technical file, PMA, CE Marking, etc.) - pre-market
• Annual Reports to regulatory bodies - postmarket
• Internal auditing support  (with global initiatives now being implemented, QA can't deal with this on their own, RA needs to pay attention and support QA) - pre & postmarket
• Review of advertisement and promotion pieces - postmarket
• Review of ALL applicable revised or new standards and/or guidances from regulatory bodies - pre & postmarket
• Determination of complaint reportability to regulatory bodies - postmarket
• Creation of regulatory-based Quality System procedures - premarket
• Clinical trial submissions (pre & postmarket)
• Risk Assessment contributor (pre & postmarket)
• and more...

Regulatory body auditing/inspection --> RA & QA shared responsibility

Some folks may disagree with me on this last one but I think this particular responsibility has changed from QA to now include RA in a lot of cases because of MDSAP and other global initiatives like clinical evaluation report needs.  QA can't handle this alone considering the QA scope is limited primarily with regulatory compliance.  RA has to really understand some of the work QA does on top of everything else (this is why a lot of companies now see the need for executive level RA&QA person or Compliance person. This person becomes the face, the management representative, who understands everything the whole organization does sometimes understand even accounting practices (Open Payments anyone?). Some of them, thankfully, finally realizes this is not a token position.

I hope that helps,

I know it could be a very silly question but I really want to clear my head with this doubt. 

What is a role of regulatory affair body in an organisation? How is there work or responsibility differ from QA authorities?