Regulatory Open Forum

What a great question...and one that has prompted my first post on this forum (having just joined RAPS recently).

I have absolutely faced this anxiety many times throughout my career, and echo a lot of what others have already said. I also note that while it should be part of our role to have our colleagues pressure test our recommendations and advice, that should never be aggressive or personal in nature.

To combat my own anxiety, I've developed a few approaches over the years that have helped me when facing this situation.

• Understanding my colleagues (customers) needs - if I know what they want to achieve, and why, I can clearly message how my advice will help them reach their goals
• I don't always quote legislation as so much of what we do is in the grey and relies on experience not legislation/guidance
• I present options, with a recommendation that I consider likely to be most palatable to the Regulators (i.e. what an Agency would like, not what I would like), acknowledging where this may not be aligned with the team's goals
• I aim to show willingness to listen to my non-Regulatory colleagues' recommendations; some also have great experience to bring, and sometimes a simple question can prompt a change in approach
• I aim to show support for the team's decision once it is made, regardless of if my recommendation is followed

Thanks again for posting a great question, I look forward to seeing how this discussion develops.

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

• Recognizing the best course of action may not be in the short-term interest of their employer.

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

• Recognizing the best course of action may not be in the short-term interest of their employer.

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

Hello Joy,

This is a great idea!

I would be very interested in joining the Task Force to revise the Code-of-Ethics.

Thanks,
Hasnaa

• Recognizing the best course of action may not be in the short-term interest of their employer.

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

Hello Joy,

This is a great idea!

I would be very interested in joining the Task Force to revise the Code-of-Ethics.

Thanks,
Hasnaa

• Recognizing the best course of action may not be in the short-term interest of their employer.

My RA experience was mostly in evaluating the output (submissions and audits) from RA professionals seeking or continuing access to the EU Market. I have witnessed business cultures where RA appears to have been embraced, supported, valued. I have seen environments where RA is tolerated, unfortunately, sometimes I have seen RA professionals enduring unreasonable pressure and lacking sufficient support, influence within the process (in my opinion).

RA would be easy if every decision was black and white, if regulations and requirements were unambiguous and crystal clear. One part of what makes the RA profession so interesting is the challenge of the interpretation of grey, based on experience, data, precedents, consideration of known risks and current expectations.

I have found the RAPS Code of Ethics valuable in reinforcing my own professional compass:

https://www.raps.org/who-we-are/code-of-ethics

Fortunately, I have worked in cultures where the overriding RA consideration was to do the right thing and reach reasoned consensus, even when unreasonable pressures were applied to support inappropriate decisions. Sometimes, on reflection, as a team we were too risk adverse and sometimes perhaps we were persuaded to be too pragmatic. That's real life and no one, no process is infallible, but I worked in cultures and environments that always supported us. I have made uncomfortable and unpopular RA decisions, but always felt I could defend my positions accepting that not everything is clear-cut.  

I always admire RA professionals who can maintain fidelity with the intent of the Code of Ethics. I think it can be very tough, sometimes a little lonely and not always appreciated, but vital to long-term viability of manufacturers and their products. Paramount in RA is the protection and benefit to patients.

Generally getting people to appreciate the long game is healthy, the celebration of getting a product cleared for the market can quickly turn very painful if problems are identified later because there was not enough attention to sufficient premarket data or analysis.   

When I have witnessed an environment and culture that appears a bit toxic to good RA practice I have wondered what I would do working in that environment, would I battle to change the culture, change minds, win support or at some point would I get frustrated and walk away to a better environment. For me one of the significant benefits of RAPS is access to a community that empathizes and understands the difficulty in RA practice and provides support to give us confidence to continue best RA practice for the benefit of all of stakeholders.

Be strong! You're never alone.      

Thank you everyone who candidly contributed their experience. It helps a great deal. 

I had the post notifications turned off and thought no one replied. Clearly, I was wrong :)

Again, thank you so much for you advice and support.

Have a wonderful rest of the week.