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

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.

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

Just so we are clear, what is RAC?

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.

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

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

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.

dallltho said:

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.

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Fifi2006's post regarding the RAC was nearly 3 years old ... probably by now, he would already be RAC EU certified

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.

dallltho said:

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.

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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

For Spring 2014, see: RAC Regulatory Affairs Spring 2014 EU or Global Exam Study Group