RAPS (Regulatory Affairs Professionals Society) books - Are they worth it?

lboll

Involved In Discussions
#1
I've been in RA for over 10 years and involved 510(k) submissions,Technical File creation and maintenance and the point person for all FDA/ISO/CE/CMDCAS audits.
I was looking at purchasing Fundamentals of US Regulatory Affairs, Seventh Edition and Fundamentals of International Regulatory Affairs, First Edition from the RAPS website as a way to expand my knowledge (not, at this time, to prep for the RAC exams).
I'm wondering though if these books will have any value to someone with lots of experience or if they are geared toward newcomers to the field?
Thanks.
 
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Marcelo

Inactive Registered Visitor
#2
I my opinion, yes, they will. I have the US, EU (the sixth editions) and International, and they really do provide a fresh refresher and even some different viewpoints when it comes to regulations.

One of the interesting points is, they are all about regulations (generally free documents) but are written in a way for it do be studied - so they are written in a total different manner. For example, they usually have tables, diagrams and figures not found in the regulations that help give a better picture of the subject. This is also true to linkages between regulations and guidance documents and everything in between.
 
M

miumiu

#3
Hello Marcelo,
My name is Mihaela and I wrote you an e-mail last week about the book
Fundamentals of EU Regulatory Affairs, Sixth Edition. Do you have it as an electronic book?
You can reply me via email on mihaela.grozdanova at gmail.

BR
Mikey
 
Last edited by a moderator:
G

Gargi

#4
Hi ,
I have around 15 months of experience in Medical device industry.I am working in regulatory dept. At this point , I wanna expand my skill sets in regulatory fied( medical devices) . Kindly suggest regulatory courses/certification( preferably online) . Also I belong to a (developing Economy hence plz suggest courses that cost reasonable amount).
Any hepl is very much appreciated!!!!:thanx:
 
I

Isaac Leduc

#5
Hi,

I've just signed up for the Autumn session 2014.

If anyone have Fundamentals of EU Regulatory Affairs, Sixth Edition to sell second hand or any RAC-EU mock exams, I would be very grateful!

Thanks,
Isaac
 
D

DanielK555

#7
Hello Paul, I might be interested, please send me a PM with your email adres, so we can discuss it.
 
#8
Hello!
Is someone selling Fundamentals of EU Reg Affairs book?
I am a Regulatory Affairs professional and I am advancing my career in Orthopedic Medical Device Industry.

Looking forward to the response, hopefully the positive one!
Thanks!
 
N

Nishant Paliwal

#9
Hi I am a regulatory affairs professional for past 12 years . I need to know could someone help me with 'Fundamentals of EU regulatory affairs book".

I have the one for US if anybody needs that
 
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