I agree with Julie and Victor here. Industries and hiring managers have particular needs. No one wants a regulatory person working for a small device company that only have an understanding of EU regulation. They would want someone who knows US, EU, Canada, etc. regulations for Medical Devices in general. I see this requirement on the upper executive levels too in all sizes of companies. That doesn't match what RAPS is putting out for RAC now. Granted some are combination products, or maybe the person is in a consulting group that handles everything. In these cases I realize the need for regionalization of RAC and I proposed that it can keep that. I just proposed to:
- ADD industry-specific RAC pertaining to the product that covers multiple regions. Ex. RAC Medical Devices (covers all devices regulations in EU, US, Canada, etc.)
RAC then will have a question on combination products too and if that combination product was designated as device, it should ask questions about requirements and dealing with reviewers from other branches.
For those folks who view the current system of RAC as extremely important to keep, you can keep it. This is just an
addition that I think
ALL RAPS members can benefit from. I don't care much for "it's always been this way" or "it's tradition" arguments when it comes to
serving other members' needs that WILL NOT take away from those who already have the current RAC and it works for them. "RAC was hard, semi-useful, and good for prestige for me so it's gotta be for you too" arguments that I see doesn't help the profession. I volunteer for RAPS, recommend RAPS to my students, attend convergence, etc. I love RAPS and this is why I see that there are groups of under-served members.
My take is, if RAC is supposed to focus on "regulated products" and is supposed to be hard, regulated products include not just devices, biologics, or drugs, is also includes FOOD, COSMETICS, dare I even say Tobacco (Congress has their ideas)? I see people in food running around RAPS convergences. RAC seem useless in that industry but RAPS the organization and people and members are important. But for some reason I don't feel they are being served adequately in terms of RAC. I'm from devices so maybe I'm wrong. I just want to remind everyone that all these US regulations started from Food and yet no one seems to mention this whole industry not being served by RAC that will be served with the addition of product-based RAC.
I hope this solution of adding onto the current RAC platform will work to serve all RAPS members.
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Clarisa Tate
VP of Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
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Original Message:
Sent: 30-Jun-2017 09:33
From: Julie Omohundro
Subject: RAC Preparation
I think Regulatory, like everything else in this world, is what you make of it. There are those practicing it today in a very "non-complex" way and those who practice it in a complex way, with depth and breadth and careful thought and deep investigation.
What I always see most of in these discussions are tidepools, everyone swimming around in their little one and thinking it's the whole wide world. The industry, the profession, and the professionals vary widely across companies and regions. It's not at all the same, and never has been, in North Carolina vs Minnesota vs Indiana vs Massachusetts vs Florida vs Texas vs California. Can't begin to imagine how it goes in Arkansas or Iowa. And then there is DC, which is it's own planet, with little to no actual regulated industry, but some very large procurers of regulated products.
There's not much point in these fine-grained arguments about what has or has not gotten more complex. The world, the industry, and the profession have all changed dramatically since the RAC was introduced. If there is a truth in this universe, it is change or die.
Either the RAC changes or it dies. I hope those who want to keep it carefully preserved in formaldehyde win out, and I, for one, will not be sorry to see it go.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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Original Message:
Sent: 29-Jun-2017 12:04
From: Ginger Glaser
Subject: RAC Preparation
I am not going to rehash the RAC discussion here (I already made my pitch for an EIR/PE style tiered system in the survey), but I do want to address this, because I really don't think the field was so much less complex 25 years ago when I started in this area. In fact, in some ways it was arguably more complex, at least geographically, as Europe had many different sets of regulations prior to CE marking and Canada was no where near as similar to other geographies as they are today.
Yes, some new regulations have come into play - but others have gone away or been simplified. And yes, there are probably more "hybrid" technologies or novel technologies. However, many of these were present back then too, there just weren't specific acknowledgements from the regulators, so we had to sort out the best approach each time. Yes, standards and expectations within given regulations have evolved over time even if the regulation is the same, but I really don't think that made things all that more complex, even if in some cases it created more work.
There may indeed be reasons to continually evolve the RAC (for instance with new regulated industries like cosmetics and tobacco etc or increased specialization within the field) but I really don't think the fact that regulatory affairs is so much more complex today is one of them.
g-
This Topic already had been discussed here and for sure there were, let's call them "two parties", one wanted to keep everything as it is and the other one agreed to have also a product related split, as the technologies and related regulatory requirements evolved a lot since the RAC had been introduced back in the day.
As a result, the complexity increased really a lot. The RAC had not been adapted that much taking into account the development of Technologies and regulatory requirements.
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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
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Original Message:
Sent: 28-Jun-2017 04:59
From: André Hülsbusch
Subject: RAC Preparation
Good Point and again another example, why there should not be only a split of Country/ Regional related Topics around the regulatory Framework. There also shall be a split of product technologies.
This Topic already had been discussed here and for sure there were, let's call them "two parties", one wanted to keep everything as it is and the other one agreed to have also a product related split, as the technologies and related regulatory requirements evolved a lot since the RAC had been introduced back in the day.
As a result, the complexity increased really a lot. The RAC had not been adapted that much taking into account the development of Technologies and regulatory requirements.
Sure, RAC had been split up into Country specific requirements, nevertheless, the different types of products still had been kept under one umbrella.
Anyway, RAPS ran a Survey and asked, beside other topics, about the current "construct" of RAC. Hopefully, they will adapt the RAC to reflect the regulatory situation nowadays as well as regulatory professional needs and not staying with a model, which fitted the needs in the past.
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André Hülsbusch
Regional QA/RA Specialist, Central Europe
Germany
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Original Message:
Sent: 27-Jun-2017 05:53
From: Arvilla Trag
Subject: RAC Preparation
Another observation from my exam - it was very heavily weighted towards medical devices: 24 of 100 questions were specifically for devices, not including questions regarding IND/IDE or combination products. Being a biotech person, this made a challenging exam even more challenging. FYI.
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Arvilla Trag, RAC
Iron River MI
United States
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Original Message:
Sent: 21-Jun-2017 19:05
From: Nick Chavda
Subject: RAC Preparation
Hi Everyone
General question about RAC exam preparation.
I have just started prepping for RAC global exam and have ordered some study material from RAPS. I am wondering if this exam would be to assess in-depth knowledge of regulations for global HAs e.g. Canada, US, EU and BRIC-M or this will only assess knowledge at high level since the scope of this exam is global & does not cover one country? For example for RAC US you only have to know the US regulations & its application within industry but what about global??
Also I do not have particular experience in pre-market, submissions etc. since being in Quality majority of my industry experience has been in managing post-market and quality-system related activities. Obviously this means i am going to focus heavily on pre-market e.g. interfacing & strategic planning but question that I have is will reviewing the study material be good enough? If not, what direction should I follow?
Appreciate your valuable insights. Thank you.
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Nick Chavda
Quality & Regulatory Compliance Manager
Johnson & Johnson Medical Products
Markham ON
Canada
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