My RAC US 2009 fall exam experience to share with you
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purple
Oct 28, 2009, 7:44:27 PM10/28/09
to Regulatory Affairs Professionals of Life Science
I finished the RAC US 2009 fall exam this morning and want to share
with you my experience. I started to pursue the certificate after
reading the informative and inspiring posts from baobio (bao-bio) at
mitbbs.com. I took the advice in one of his posts - an excellent guide
to RAC US preparation. Please click on the link below to read about
his insightful opinions.
http://www.mitbbs.com/article/Pharmaceutical/29224438_4.html
After taking my exam, I wish I should have done better with all the
following points in preparing for it.
* Know as much as possible about QSR (part 820), cGMP (part 210-211),
510(k)
* PAS (Prior-approval supplements), CBE (Changes Being Effected
supplement), CBE-30
* Significant dates (safety report, record retention, response or
effective date)
* What to lead to a clinical hold and how to do with it
* Submission requirements in details: 510(k), PMA, IND/IDE, NDA/BLA/
ANDA, orphan status/HDE
* Meetings with FDA
* Sponsor, IRB, investigator responsibilities
* Recalls
* Differences between misbranding and adulteration (Not meeting the 510
(k) requirements is considered to be misbranded NOT adulterated)
* Adverse event reporting (when, how)
* Establishment registration (who, how)
* FDA inspections (when, forms, what to inspect)
* Environmental assessment
* ANDA (certification, patent infringement)
* Differences between drug labeling and advertising (the brief summary
requirement, reminder advertising)
I am trying to provide as accurate information as possible but there
might be some errors. Please feel free to comment.
Good luck to you all with the exams.
with you my experience. I started to pursue the certificate after
reading the informative and inspiring posts from baobio (bao-bio) at
mitbbs.com. I took the advice in one of his posts - an excellent guide
to RAC US preparation. Please click on the link below to read about
his insightful opinions.
http://www.mitbbs.com/article/Pharmaceutical/29224438_4.html
After taking my exam, I wish I should have done better with all the
following points in preparing for it.
* Know as much as possible about QSR (part 820), cGMP (part 210-211),
510(k)
* PAS (Prior-approval supplements), CBE (Changes Being Effected
supplement), CBE-30
* Significant dates (safety report, record retention, response or
effective date)
* What to lead to a clinical hold and how to do with it
* Submission requirements in details: 510(k), PMA, IND/IDE, NDA/BLA/
ANDA, orphan status/HDE
* Meetings with FDA
* Sponsor, IRB, investigator responsibilities
* Recalls
* Differences between misbranding and adulteration (Not meeting the 510
(k) requirements is considered to be misbranded NOT adulterated)
* Adverse event reporting (when, how)
* Establishment registration (who, how)
* FDA inspections (when, forms, what to inspect)
* Environmental assessment
* ANDA (certification, patent infringement)
* Differences between drug labeling and advertising (the brief summary
requirement, reminder advertising)
I am trying to provide as accurate information as possible but there
might be some errors. Please feel free to comment.
Good luck to you all with the exams.
megan
Oct 28, 2009, 10:39:28 PM10/28/09
to Regulatory Affairs Professionals of Life Science
congrats! and thanks for sharing.
xiue...@hotmail.com
Nov 3, 2009, 4:19:43 PM11/3/09
to Regulatory Affairs Professionals of Life Science
Thanks a lot for sharing.
purple
Dec 21, 2009, 11:00:54 AM12/21/09
to Regulatory Affairs Professionals of Life Science
EXAM RESULTS from RAPS today
Candidate Results: PASS
Candidate's Score: 81%
Passing Score: 75%
Happy holidays and wish you all a wonderful new year of 2010!
Candidate Results: PASS
Candidate's Score: 81%
Passing Score: 75%
Happy holidays and wish you all a wonderful new year of 2010!
On Nov 3, 4:19 pm, "xiue_...@hotmail.com" <xiue_...@hotmail.com>
wrote:
baobio
Dec 21, 2009, 11:41:20 AM12/21/09
to Regulatory Affairs Professionals of Life Science
Congratulations!
I also passed with a similar score, but mine is the EU version!
I also passed with a similar score, but mine is the EU version!
-Baobio
purple
Dec 21, 2009, 2:10:16 PM12/21/09
to Regulatory Affairs Professionals of Life Science
Hello baobio,
Congratulations! Would you please write another wonderful post about
your RAC EU exam experience at your most convenient time? Special
thanks to your previous writing and emails about the RAC US exam.
Thank you!!!
Merry Christmas and Happy New Year!
Purple
Message has been deleted
xiue...@hotmail.com
Jan 20, 2010, 4:28:52 PM1/20/10
to Regulatory Affairs Professionals of Life Science
I also passed the RAC US exam with a 85% score. I will post my study
notes later on.
Xiue
notes later on.
Xiue
> > > Happy holidays and wish you all a wonderful new year of 2010!- Hide quoted text -
>
> - Show quoted text -
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