Regulatory Open Forum

Hello RAPS fellows,

I am currently preparing for RAC (EU) Autumn exam for this year and referring to the 7th edition of RAPS book. I need some advice on whether to refer to the most recent version of the book i.e. 8th edition which was released <g class="gr_ gr_675 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="675" data-gr-id="675">in</g> the beginning of this year and what level of regulations to study (recently changed or ones already in place). 

RAC practice guide says that questions will be based on guidelines and regulations effective 31 December of the prior year. Does this mean that for Medical Devices, questions will be from MDR or both MDD/ MDR since both are effective (Just as an example? I am concerned because EU regulatory environment has changed in the Pharma sector as well since the release of <g class="gr_ gr_1209 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="1209" data-gr-id="1209">previous</g> version of the book. 

I appreciate all the feedback and recommendations. Thank you in advance. 
 


------------------------------
Heena T.
IN, United States
------------------------------

​Hi Heena,

I hope you're doing well.  I too have the same concerns in terms of the content to be covered for the EU RAC exam this Fall.  Based on what you have written and on what I have heard from RAPS though, the 8th edition (of the two) appears to be the appropriate version to study, at least to me.  Yet reading the 8th edition, in places it says (and I'm paraphrasing here) 'based on current interpretations' or 'based on current guidance documents' the approach is...
As you know, all the MDR guidance documents are not yet available (and some written policies appear at least a bit murky to me).  Due to all the recent and upcoming changes, I contacted RAPS to determine when the next EU edition will be released.  I'm told it will be on the same schedule as the others; it's done every two years, so the next edition will be at the end of 2019.  Thus, I'm trying to consider if now is the time to move forward with taking the exam, or to wait until the guidance documents and policies are more in place.  Thoughts?  Regardless, are you currently a part of an EU Study group?  Such a group to me, was essential to passing the US RAC Exam.  If I decide to take it by the end of the month, I would be happy to join or start a group with you.

Your feedback is appreciated.

------------------------------
Reuben Lidster
Bloomington IN
------------------------------

Original Message:
Sent: 14-May-2018 13:36
From: Heena Thakkar
Subject: RAC (EU) 2018

Hello RAPS fellows,

I am currently preparing for RAC (EU) Autumn exam for this year and referring to the 7th edition of RAPS book. I need some advice on whether to refer to the most recent version of the book i.e. 8th edition which was released <g class="gr_ gr_675 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="675" data-gr-id="675">in</g> the beginning of this year and what level of regulations to study (recently changed or ones already in place).

RAC practice guide says that questions will be based on guidelines and regulations effective 31 December of the prior year. Does this mean that for Medical Devices, questions will be from MDR or both MDD/ MDR since both are effective (Just as an example? I am concerned because EU regulatory environment has changed in the Pharma sector as well since the release of <g class="gr_ gr_1209 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="1209" data-gr-id="1209">previous</g> version of the book.

I appreciate all the feedback and recommendations. Thank you in advance.



------------------------------
Heena T.
IN, United States
------------------------------

If you are thinking of starting a study group for the EU RAC I'd be interested to join.

------------------------------
Simão Paiva
Regulatory Project Manager
Cambridge
United Kingdom
------------------------------

Original Message:
Sent: 15-May-2018 09:56
From: Reuben Lidster
Subject: RAC (EU) 2018

​Hi Heena,

I hope you're doing well.  I too have the same concerns in terms of the content to be covered for the EU RAC exam this Fall.  Based on what you have written and on what I have heard from RAPS though, the 8th edition (of the two) appears to be the appropriate version to study, at least to me.  Yet reading the 8th edition, in places it says (and I'm paraphrasing here) 'based on current interpretations' or 'based on current guidance documents' the approach is...
As you know, all the MDR guidance documents are not yet available (and some written policies appear at least a bit murky to me).  Due to all the recent and upcoming changes, I contacted RAPS to determine when the next EU edition will be released.  I'm told it will be on the same schedule as the others; it's done every two years, so the next edition will be at the end of 2019.  Thus, I'm trying to consider if now is the time to move forward with taking the exam, or to wait until the guidance documents and policies are more in place.  Thoughts?  Regardless, are you currently a part of an EU Study group?  Such a group to me, was essential to passing the US RAC Exam.  If I decide to take it by the end of the month, I would be happy to join or start a group with you.

Your feedback is appreciated.

------------------------------
Reuben Lidster
Bloomington IN

Original Message:
Sent: 14-May-2018 13:36
From: Heena Thakkar
Subject: RAC (EU) 2018

Hello RAPS fellows,

I am currently preparing for RAC (EU) Autumn exam for this year and referring to the 7th edition of RAPS book. I need some advice on whether to refer to the most recent version of the book i.e. 8th edition which was released <g class="gr_ gr_675 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="675" data-gr-id="675">in</g> the beginning of this year and what level of regulations to study (recently changed or ones already in place).

RAC practice guide says that questions will be based on guidelines and regulations effective 31 December of the prior year. Does this mean that for Medical Devices, questions will be from MDR or both MDD/ MDR since both are effective (Just as an example? I am concerned because EU regulatory environment has changed in the Pharma sector as well since the release of <g class="gr_ gr_1209 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="1209" data-gr-id="1209">previous</g> version of the book.

I appreciate all the feedback and recommendations. Thank you in advance.



------------------------------
Heena T.
IN, United States
------------------------------

​Hi Heena,

Just to clarify, and as per the RAC Candidate Guide, RAC exams sat in 2018 will be based on regulation in effect through December 31, 2016.

What this means is that regulations that went into effect on January 1, 2017 or later, will not be specifically tested in the exam.

Please note that the exams are also reviewed to ensure that questions are not 'out of date' and that a correct answer is at the time the exam is taken still a current valid answer. The exam is not designed to 'trick' anyone by referencing expired regulations that are no longer followed.

Regards,   


------------------------------
Pete Etchells
RAC Manager
Rockville MD
United States
------------------------------

Original Message:
Sent: 14-May-2018 13:36
From: Heena Thakkar
Subject: RAC (EU) 2018

Hello RAPS fellows,

I am currently preparing for RAC (EU) Autumn exam for this year and referring to the 7th edition of RAPS book. I need some advice on whether to refer to the most recent version of the book i.e. 8th edition which was released <g class="gr_ gr_675 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="675" data-gr-id="675">in</g> the beginning of this year and what level of regulations to study (recently changed or ones already in place).

RAC practice guide says that questions will be based on guidelines and regulations effective 31 December of the prior year. Does this mean that for Medical Devices, questions will be from MDR or both MDD/ MDR since both are effective (Just as an example? I am concerned because EU regulatory environment has changed in the Pharma sector as well since the release of <g class="gr_ gr_1209 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="1209" data-gr-id="1209">previous</g> version of the book.

I appreciate all the feedback and recommendations. Thank you in advance.



------------------------------
Heena T.
IN, United States
------------------------------

Dear Pete,

Thank you for your insights on the post. I might have looked thoroughly but now that I have, RAC 2018 guide also mentions that questions will be based on regulations and guidelines effective up until Dec 2016, which means probably no MDR questions for medical devices. 

Also, I confirmed with RAPS in the meantime about some similar concerns and they said current exams do not have MDR questions yet. I am just passing along what I found out but I'd go with the basic preparation of new regulations as well, just in case. 

Dear Reuben and Simao, 
I am not aware of any study group so far for the fall intake (maybe there is none), but I will be happy start one. How about we connect via Whatsapp and go from there? 
Let me know!

Thanks again to everyone for inputs and feedback!
Heena

------------------------------
Heena Thakkar
Warsaw IN
United States
------------------------------

Original Message:
Sent: 16-May-2018 09:48
From: Pete Etchells
Subject: RAC (EU) 2018

​Hi Heena,

Just to clarify, and as per the RAC Candidate Guide, RAC exams sat in 2018 will be based on regulation in effect through December 31, 2016.

What this means is that regulations that went into effect on January 1, 2017 or later, will not be specifically tested in the exam.

Please note that the exams are also reviewed to ensure that questions are not 'out of date' and that a correct answer is at the time the exam is taken still a current valid answer. The exam is not designed to 'trick' anyone by referencing expired regulations that are no longer followed.

Regards,


------------------------------
Pete Etchells
RAC Manager
Rockville MD
United States

Original Message:
Sent: 14-May-2018 13:36
From: Heena Thakkar
Subject: RAC (EU) 2018

Hello RAPS fellows,

I am currently preparing for RAC (EU) Autumn exam for this year and referring to the 7th edition of RAPS book. I need some advice on whether to refer to the most recent version of the book i.e. 8th edition which was released <g class="gr_ gr_675 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="675" data-gr-id="675">in</g> the beginning of this year and what level of regulations to study (recently changed or ones already in place).

RAC practice guide says that questions will be based on guidelines and regulations effective 31 December of the prior year. Does this mean that for Medical Devices, questions will be from MDR or both MDD/ MDR since both are effective (Just as an example? I am concerned because EU regulatory environment has changed in the Pharma sector as well since the release of <g class="gr_ gr_1209 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="1209" data-gr-id="1209">previous</g> version of the book.

I appreciate all the feedback and recommendations. Thank you in advance.



------------------------------
Heena T.
IN, United States
------------------------------

Hi, I would be interested in joining the study group as well. PLease let me know 

Thanks 
SAI

------------------------------
Sai Prathyusha Bhamidipati
Manager, Regulatory Affairs
Cambridge MA
United States
------------------------------

Original Message:
Sent: 16-May-2018 13:52
From: Heena Thakkar
Subject: RAC (EU) 2018

Dear Pete,

Thank you for your insights on the post. I might have looked thoroughly but now that I have, RAC 2018 guide also mentions that questions will be based on regulations and guidelines effective up until Dec 2016, which means probably no MDR questions for medical devices.

Also, I confirmed with RAPS in the meantime about some similar concerns and they said current exams do not have MDR questions yet. I am just passing along what I found out but I'd go with the basic preparation of new regulations as well, just in case.

Dear Reuben and Simao,
I am not aware of any study group so far for the fall intake (maybe there is none), but I will be happy start one. How about we connect via Whatsapp and go from there?
Let me know!

Thanks again to everyone for inputs and feedback!
Heena

------------------------------
Heena Thakkar
Warsaw IN
United States

Original Message:
Sent: 16-May-2018 09:48
From: Pete Etchells
Subject: RAC (EU) 2018

​Hi Heena,

Just to clarify, and as per the RAC Candidate Guide, RAC exams sat in 2018 will be based on regulation in effect through December 31, 2016.

What this means is that regulations that went into effect on January 1, 2017 or later, will not be specifically tested in the exam.

Please note that the exams are also reviewed to ensure that questions are not 'out of date' and that a correct answer is at the time the exam is taken still a current valid answer. The exam is not designed to 'trick' anyone by referencing expired regulations that are no longer followed.

Regards,


------------------------------
Pete Etchells
RAC Manager
Rockville MD
United States

Original Message:
Sent: 14-May-2018 13:36
From: Heena Thakkar
Subject: RAC (EU) 2018

Hello RAPS fellows,

I am currently preparing for RAC (EU) Autumn exam for this year and referring to the 7th edition of RAPS book. I need some advice on whether to refer to the most recent version of the book i.e. 8th edition which was released <g class="gr_ gr_675 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="675" data-gr-id="675">in</g> the beginning of this year and what level of regulations to study (recently changed or ones already in place).

RAC practice guide says that questions will be based on guidelines and regulations effective 31 December of the prior year. Does this mean that for Medical Devices, questions will be from MDR or both MDD/ MDR since both are effective (Just as an example? I am concerned because EU regulatory environment has changed in the Pharma sector as well since the release of <g class="gr_ gr_1209 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="1209" data-gr-id="1209">previous</g> version of the book.

I appreciate all the feedback and recommendations. Thank you in advance.



------------------------------
Heena T.
IN, United States
------------------------------