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Regulatory Affairs Certification (RAC) April/May EU Exam - Anyone doing it?

F

Fifi2006

#1
Hi,

I just signed up to do the RAC April/May EU Exam. I was wondering if anyone on here is doing it also? If so, what study materials are you using? Do you know where you get sample questions?

I am basically learning the MDD, MEDDEVS etc. Hopefully that will be enough. I have also worked in Quality Systems and dealt with external auditors for a few years. I am hope hoping all of this will give me enough knowledge to be successful in the exam.

F.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: RAC April/May EU Exam - Anyone doing it?

Just so we are clear, what is RAC?
 
F

Fifi2006

#3
Re: RAC April/May EU Exam - Anyone doing it?

It is the Regulatory Affairs Certification (RAC) that you can get through the Regulatory Affairs Professionals Society (RAPS).

RAPS is a global membership organization of regulatory professionals in the medical device, pharmaceutical and biotechnology.

In order to obtain a RAPS certification you must sit an exam. In my case I am doing the RAC about the EU regulations on medical devices, in vitro diagnostics and medicinal products.
 
L

Leona78

#4
I am going to prepare RAC EU and probably try the examination by next year's spring session. Is anyone doing the same? How long does it take in terms of study/exercise? Do you have any useful advice?
Any suggestion is welcome!
Thanks,
Elena
 
N

Nikhli

#5
Hello Fifi 2006/ Leona 78,

I am planning to take RAC EU Exam in Spring, 2014. I am looking to collaborate with someone for the preparation. I live in the United States.

I have cleared RAC US and I have found Fundamentals of US regulations book very helpful so I have started with Fundamentals of EU Regulations book. I think it is an excellent source to begin with. I am not sure of sample questions. In fact, I am in search of sample questions too. Please let me know if you find any. I will do the same.
In terms of study/Exercise- 4-6 months is idle. However, it depends on how intense your preparation would be and how much amount of time you would be able to dedicate for the preparation on a daily basis.


Regards,
Nikhil
 
D

dallltho

#6
Nikhil, are you still interested in studying with someone for the RAC EU exam for Spring 2014?

I too am in the United States. I currently work in RA for Medical devices, what about you?

Perhaps we could chat sometime on a Google Hangout or via skype?

My skype is oantigoelderthomas.
 

Ajit Basrur

Staff member
Admin
#7
Fifi2006, are you still looking at creating a study group? Have you done so already? I'm interested in either doing the RAC EU or the RAC Global depending on which one I can find a study group for. I am in the US. Interested in doing either skype (my skype name is no my profile) or via Google hangout.

Let me know.
Fifi2006's post regarding the RAC was nearly 3 years old ... probably by now, he would already be RAC EU certified :)
 
D

dallltho

#8
Ajit, thanks. You are correct. I am new to forums in general and to Elsmar. I deleted my post as it was not relevant. Sorry for my newbie mistake. :)
 

Ajit Basrur

Staff member
Admin
#9
Ajit, thanks. You are correct. I am new to forums in general and to Elsmar. I deleted my post as it was not relevant. Sorry for my newbie mistake. :)
Hi dalltho, not an issue at all ... you could have retained your post ... its fine ... some one else would have approached :)

Thanks for your participation here :bigwave:
 
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