Regulatory Open Forum

We have heard the discussion on RegEx forum regarding MDSAP preparation and noticed some interest in guidance on how manufacturers prepare for MDSAP audits (particularly addressing individual country requirements). RAPS has already contacted some subject experts from within the RAPS community and we are considering options for a possible webcast or series of webcasts. Happy to receive more input on what is needed and hope to have more news soon.

We have heard the discussion on RegEx forum regarding MDSAP preparation and noticed some interest in guidance on how manufacturers prepare for MDSAP audits (particularly addressing individual country requirements). RAPS has already contacted some subject experts from within the RAPS community and we are considering options for a possible webcast or series of webcasts. Happy to receive more input on what is needed and hope to have more news soon.

Brexit is undoubtedly causing confusion and undermining confidence. All stakeholders need Brexit to be resolved as soon as possible. Many are making contingency plans for a possible hard Brexit but we are all hoping for a solution that maintains a steady and consistent regulatory landscape for the EU and UK. We are in the realm of politics and all relevant stakeholders are lobbying for a satisfactory and workable resolution. One thing is for sure Brexit is unhelpful during the MDR and IVDR implementation.  

Brexit is undoubtedly causing confusion and undermining confidence. All stakeholders need Brexit to be resolved as soon as possible. Many are making contingency plans for a possible hard Brexit but we are all hoping for a solution that maintains a steady and consistent regulatory landscape for the EU and UK. We are in the realm of politics and all relevant stakeholders are lobbying for a satisfactory and workable resolution. One thing is for sure Brexit is unhelpful during the MDR and IVDR implementation.  

The US IVD regulatory environment is an evolving situation, clearly, we saw some proposals in 2017 and no doubt there will be further developments. RAPS RF covers news daily and this RegEx forum is a great place to exchange views on this topic.

Companion diagnostics is a dynamic space and outside my personal area of direct experience, but, within the RAPS community there are IVD experts who should and do engage on this discussion including sessions at our annual Convergence conference.   

The US IVD regulatory environment is an evolving situation, clearly, we saw some proposals in 2017 and no doubt there will be further developments. RAPS RF covers news daily and this RegEx forum is a great place to exchange views on this topic.

Companion diagnostics is a dynamic space and outside my personal area of direct experience, but, within the RAPS community there are IVD experts who should and do engage on this discussion including sessions at our annual Convergence conference.   

The US IVD regulatory environment is an evolving situation, clearly, we saw some proposals in 2017 and no doubt there will be further developments. RAPS RF covers news daily and this RegEx forum is a great place to exchange views on this topic.

Companion diagnostics is a dynamic space and outside my personal area of direct experience, but, within the RAPS community there are IVD experts who should and do engage on this discussion including sessions at our annual Convergence conference.   

The US IVD regulatory environment is an evolving situation, clearly, we saw some proposals in 2017 and no doubt there will be further developments. RAPS RF covers news daily and this RegEx forum is a great place to exchange views on this topic.

Companion diagnostics is a dynamic space and outside my personal area of direct experience, but, within the RAPS community there are IVD experts who should and do engage on this discussion including sessions at our annual Convergence conference.   

The answer may depend on individual circumstances and goals. Different employers may value credentials differently, but in general, regulatory experience is most highly valued. Whether you choose to pursue a degree, certificate or something else, it should be part of a larger plan to gain practical experience in your chosen area. Not only will it be noticed by employers, but it will help you learn how to apply your knowledge and gain confidence.

We often see on RegEx the concerns about how to gain more experience and we are thinking about the RAPS community can help.

The US IVD regulatory environment is an evolving situation, clearly, we saw some proposals in 2017 and no doubt there will be further developments. RAPS RF covers news daily and this RegEx forum is a great place to exchange views on this topic.

Companion diagnostics is a dynamic space and outside my personal area of direct experience, but, within the RAPS community there are IVD experts who should and do engage on this discussion including sessions at our annual Convergence conference.   

The answer may depend on individual circumstances and goals. Different employers may value credentials differently, but in general, regulatory experience is most highly valued. Whether you choose to pursue a degree, certificate or something else, it should be part of a larger plan to gain practical experience in your chosen area. Not only will it be noticed by employers, but it will help you learn how to apply your knowledge and gain confidence.

We often see on RegEx the concerns about how to gain more experience and we are thinking about the RAPS community can help.

The US IVD regulatory environment is an evolving situation, clearly, we saw some proposals in 2017 and no doubt there will be further developments. RAPS RF covers news daily and this RegEx forum is a great place to exchange views on this topic.

Companion diagnostics is a dynamic space and outside my personal area of direct experience, but, within the RAPS community there are IVD experts who should and do engage on this discussion including sessions at our annual Convergence conference.   

I think RAPS has to do both--leading the profession and supporting the professional. There is much greater recognition now than ever before of how regulatory knowledge and expertise impacts organizations' strategic and business success. Building awareness of what regulatory professionals do and its importance is a key part of how RAPS works to advance the profession. We also recognize the need for individuals build their own skills and competencies in a range of areas, so we offer education and training through online courses, publications and face-to-face events.

RAPS has set ourselves the following strategic priorities for the next three years:

• Proactively address evolving regulatory competencies required for the global profession
• Deliver valuable and accessible learning and professional development experiences  
• Inform regulatory professionals of complex and evolving healthcare product regulatory developments
• Empower a community focused on interactions, relationships and knowledge-sharing

But RAPS staff will not move the needle alone. Engagement and leadership from the entire RAPS community is needed to progress this and many other priorities.

The answer may depend on individual circumstances and goals. Different employers may value credentials differently, but in general, regulatory experience is most highly valued. Whether you choose to pursue a degree, certificate or something else, it should be part of a larger plan to gain practical experience in your chosen area. Not only will it be noticed by employers, but it will help you learn how to apply your knowledge and gain confidence.

We often see on RegEx the concerns about how to gain more experience and we are thinking about the RAPS community can help.

The US IVD regulatory environment is an evolving situation, clearly, we saw some proposals in 2017 and no doubt there will be further developments. RAPS RF covers news daily and this RegEx forum is a great place to exchange views on this topic.

Companion diagnostics is a dynamic space and outside my personal area of direct experience, but, within the RAPS community there are IVD experts who should and do engage on this discussion including sessions at our annual Convergence conference.   

I think RAPS has to do both--leading the profession and supporting the professional. There is much greater recognition now than ever before of how regulatory knowledge and expertise impacts organizations' strategic and business success. Building awareness of what regulatory professionals do and its importance is a key part of how RAPS works to advance the profession. We also recognize the need for individuals build their own skills and competencies in a range of areas, so we offer education and training through online courses, publications and face-to-face events.

RAPS has set ourselves the following strategic priorities for the next three years:

• Proactively address evolving regulatory competencies required for the global profession
• Deliver valuable and accessible learning and professional development experiences  
• Inform regulatory professionals of complex and evolving healthcare product regulatory developments
• Empower a community focused on interactions, relationships and knowledge-sharing

But RAPS staff will not move the needle alone. Engagement and leadership from the entire RAPS community is needed to progress this and many other priorities.

The answer may depend on individual circumstances and goals. Different employers may value credentials differently, but in general, regulatory experience is most highly valued. Whether you choose to pursue a degree, certificate or something else, it should be part of a larger plan to gain practical experience in your chosen area. Not only will it be noticed by employers, but it will help you learn how to apply your knowledge and gain confidence.

We often see on RegEx the concerns about how to gain more experience and we are thinking about the RAPS community can help.

The US IVD regulatory environment is an evolving situation, clearly, we saw some proposals in 2017 and no doubt there will be further developments. RAPS RF covers news daily and this RegEx forum is a great place to exchange views on this topic.

Companion diagnostics is a dynamic space and outside my personal area of direct experience, but, within the RAPS community there are IVD experts who should and do engage on this discussion including sessions at our annual Convergence conference.   

There are many parts to this question, I can try to address some of them. With limited time available one great way to engage in RAPS is the RegEx Forum, it can take a few minutes a day and provides an excellent opportunity to learn about common concerns and trending topics. RegEx also provide a great opportunity to not only learn but give back to the community – truly members supporting members, sharing experience and tapping into the community experience. These little moments of engagement and interaction add up to quite a lot over the course of a year-and they can be where some of the best nuggets of insight and information come from. There are many other volunteer opportunities at RAPS and RAC preparation is something that can be tackled a bit at time using RAPS resources.

RAPS always welcomes all regulatory staff to Convergence and we are always open to ideas on how to support their participation within RAPS budget constraints (as a non-profit RAPS will operate a budget towards achieving breakeven in 2018). For those who simply cannot travel to be there onsite, there are also ways to engage virtually. While they would miss the face-to-face interactions, they would still be able to access valuable content.

I think RAPS has to do both--leading the profession and supporting the professional. There is much greater recognition now than ever before of how regulatory knowledge and expertise impacts organizations' strategic and business success. Building awareness of what regulatory professionals do and its importance is a key part of how RAPS works to advance the profession. We also recognize the need for individuals build their own skills and competencies in a range of areas, so we offer education and training through online courses, publications and face-to-face events.

RAPS has set ourselves the following strategic priorities for the next three years:

• Proactively address evolving regulatory competencies required for the global profession
• Deliver valuable and accessible learning and professional development experiences  
• Inform regulatory professionals of complex and evolving healthcare product regulatory developments
• Empower a community focused on interactions, relationships and knowledge-sharing

But RAPS staff will not move the needle alone. Engagement and leadership from the entire RAPS community is needed to progress this and many other priorities.

The answer may depend on individual circumstances and goals. Different employers may value credentials differently, but in general, regulatory experience is most highly valued. Whether you choose to pursue a degree, certificate or something else, it should be part of a larger plan to gain practical experience in your chosen area. Not only will it be noticed by employers, but it will help you learn how to apply your knowledge and gain confidence.

We often see on RegEx the concerns about how to gain more experience and we are thinking about the RAPS community can help.

The US IVD regulatory environment is an evolving situation, clearly, we saw some proposals in 2017 and no doubt there will be further developments. RAPS RF covers news daily and this RegEx forum is a great place to exchange views on this topic.

Companion diagnostics is a dynamic space and outside my personal area of direct experience, but, within the RAPS community there are IVD experts who should and do engage on this discussion including sessions at our annual Convergence conference.