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What is Clinical Affairs?

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What is Clinical Affairs?

Postby S. Brian » Fri Dec 07, 2012 9:16 am

Hi,

I've seen this title most often associated with device manufacturers. Am I right in thinking that Clinical Affairs is synonymous with Regulatory Affairs? Or, is the former term more specific to the device industry and the latter, perhaps, more related to pharma?

Related to this question, is it commonplace for people with regulatory affairs responsibilities to move between pharmaceuticals (drugs) and devices, or is the relevant knowledge highly industry-specific? It seems (from LinkedIn) that many working in Clinical Affairs do not hold PhDs.

Thank you.
S. Brian
 
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Joined: Sat Jul 28, 2012 4:25 pm

Re: What is Clinical Affairs?

Postby PG » Fri Dec 07, 2012 5:16 pm

Clinical affairs and regulatory affairs are different but are sometimes performed by the same person which means that there is some overlap.

Clinical affairs usually means someone who is working with clinical studies in some form while regulatory affairs means working with authorities such as the FDA.

Sometimes these are combined into a single position and sometimes not. Clinical affairs often does not require a PhD but specialized training that is often provided by the company after employment.
PG
 
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Re: What is Clinical Affairs?

Postby S. Brian » Mon Dec 10, 2012 8:37 am

PG wrote:Clinical affairs and regulatory affairs are different but are sometimes performed by the same person which means that there is some overlap.

Clinical affairs usually means someone who is working with clinical studies in some form while regulatory affairs means working with authorities such as the FDA.

Sometimes these are combined into a single position and sometimes not. Clinical affairs often does not require a PhD but specialized training that is often provided by the company after employment.


Thanks PG. Do you know if people commonly move between roles the devices and pharma industries within regulatory affairs roles?
S. Brian
 
Posts: 11
Joined: Sat Jul 28, 2012 4:25 pm

Re: What is Clinical Affairs?

Postby PG » Mon Dec 10, 2012 3:42 pm

I have seen people with senior positions in either clinical or regulatory move to the other type of positions and I have seen people move from Pharma to devices. So far I have not seen anyone move from devices to pharma (note that I am not saying that it cant happen just that I havent seen it).
PG
 
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Joined: Tue Jan 10, 2012 11:28 pm


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