Regulatory Open Forum

In convincing top management to comply with the requirements under the Federal Food, Drug, and Cosmetic Act or those under the fraud and abuse statutes, the most persuasive argument is: 

1. It's the right thing to do.  
2. It's the law. 
3. It will help us sell better products. 
4. If we don't comply, we can be subject to regulatory sanctions. 

You are still going strong, Nancy! Congrats!
I like your list, with 'it's the right thing to do' at the top. Couldn't agree more.

Best wishes

In convincing top management to comply with the requirements under the Federal Food, Drug, and Cosmetic Act or those under the fraud and abuse statutes, the most persuasive argument is: 

1. It's the right thing to do.  
2. It's the law. 
3. It will help us sell better products. 
4. If we don't comply, we can be subject to regulatory sanctions. 

Rod,
Thanks for replying  I would really like your opinion. Out of the list  mentioned above, which is your number 1 choice. My number 1 choice as a lawyer would be it is the law.
Thanks in advance for engaging on this topic.
Nancy 

You are still going strong, Nancy! Congrats!
I like your list, with 'it's the right thing to do' at the top. Couldn't agree more.

Best wishes

In convincing top management to comply with the requirements under the Federal Food, Drug, and Cosmetic Act or those under the fraud and abuse statutes, the most persuasive argument is: 

1. It's the right thing to do.  
2. It's the law. 
3. It will help us sell better products. 
4. If we don't comply, we can be subject to regulatory sanctions. 

Rod,
Thanks for replying  I would really like your opinion. Out of the list  mentioned above, which is your number 1 choice. My number 1 choice as a lawyer would be it is the law.
Thanks in advance for engaging on this topic.
Nancy 

You are still going strong, Nancy! Congrats!
I like your list, with 'it's the right thing to do' at the top. Couldn't agree more.

Best wishes

In convincing top management to comply with the requirements under the Federal Food, Drug, and Cosmetic Act or those under the fraud and abuse statutes, the most persuasive argument is: 

1. It's the right thing to do.  
2. It's the law. 
3. It will help us sell better products. 
4. If we don't comply, we can be subject to regulatory sanctions. 

In convincing top management to comply with the requirements under the Federal Food, Drug, and Cosmetic Act or those under the fraud and abuse statutes, the most persuasive argument is: 

1. It's the right thing to do.  
2. It's the law. 
3. It will help us sell better products. 
4. If we don't comply, we can be subject to regulatory sanctions. 

I've experienced numerous challenges with various Chief Medical Officers and their direct reports in Senior Leadership regarding regulatory training assignments mostly in GCP and GVP compliance areas.  Their argument is always about how their time is important, and they don't execute the daily tasks for clinical trials (although they are the final signatory approval of clinical trial protocols & amendments and Investigator's Brochure).

I've finally had enough recently and I told them that it is important that they are trained and knowledgeable because if there is a 483, warning letter, or any regulatory citation, those will be addressed either to them or the CEO depending on the org chart review by the regulatory inspectors.  

In convincing top management to comply with the requirements under the Federal Food, Drug, and Cosmetic Act or those under the fraud and abuse statutes, the most persuasive argument is: 

1. It's the right thing to do.  
2. It's the law. 
3. It will help us sell better products. 
4. If we don't comply, we can be subject to regulatory sanctions. 

Nancy,

I would add to you list:

5. If you do not know the laws regarding the industry you work in, you won't know you have broken the law until you are indicted.

My personal favorite spin on #5:

5.  If you do not know the laws regarding the industry you work in you could end up in an orange jumpsuit, slow dancing with some big guy named Bubba.

That usually gets their attention.<o:p></o:p>

I've experienced numerous challenges with various Chief Medical Officers and their direct reports in Senior Leadership regarding regulatory training assignments mostly in GCP and GVP compliance areas.  Their argument is always about how their time is important, and they don't execute the daily tasks for clinical trials (although they are the final signatory approval of clinical trial protocols & amendments and Investigator's Brochure).

I've finally had enough recently and I told them that it is important that they are trained and knowledgeable because if there is a 483, warning letter, or any regulatory citation, those will be addressed either to them or the CEO depending on the org chart review by the regulatory inspectors.  

In convincing top management to comply with the requirements under the Federal Food, Drug, and Cosmetic Act or those under the fraud and abuse statutes, the most persuasive argument is: 

1. It's the right thing to do.  
2. It's the law. 
3. It will help us sell better products. 
4. If we don't comply, we can be subject to regulatory sanctions.