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RQM+ is counting down the days until we can join the RAPS community at the virtual RAPS Convergence 2020 on 13-16 September 2020. As many of you know, the Convergence is the largest annual gathering of regulatory professionals from around the world.
While we'll miss interacting with everyone onsite and having fun at our exhibit booth, we're embracing this year's online format and will be doing everything we can to communicate our team's energy and expertise virtually.
Thankfully, we have two can't-miss speaking sessions to help us do that!
Special RAPS Convergence Edition —
RQM+ Live! #18: Generating Sufficient Clinical Evidence Under EU MDR
Monday, 14 September 2020
12:00 - 12:45 p.m. EDT
It's true: we'll be bringing a special edition of RQM+ Live! to this year's RAPS Convergence! If you've seen our biweekly show before you know we're not afraid to ask (and answer) the difficult questions, engage in healthy debates, and have a few laughs.
Demonstrating "sufficient clinical evidence" is arguably the biggest and most expensive challenge presented by the EU MDR. If you don't have adequate clinical data, what are your options to achieve MDR compliance... especially if you are no longer able to claim equivalency? Our panel of experts will discuss the following and more:
- Identifying clinical evidence gaps
- Best practices and novel approaches to fulfilling sufficient clinical evidence requirements, supported by those that have been accepted by notified bodies in audits
- Creative ideas for generating data during the COVID-19 pandemic especially when faced with expectations of receiving minimal feedback or having low study enrollment
Our panel:
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services, R&Q
- Amie Smirthwaite BEng, Ph.D. – Senior Director, Global Clinical Practice, Maetrics
- Jon Gimbel, Ph.D. – Executive Director, Regulatory & Quality Consulting Services, R&Q
- Celeste Maksim, Ph.D. – Principal Consultant, R&Q
- Ron Sills – Senior Principal Specialist, R&Q
See the session on the RAPS Convergence agenda.
Please note panelist information at link may not be up to date.
Whether you're attending RAPS or not, submit your email address above (if you're reading this in an email, click through to the blog) to be notified when the recording is available.
Post-Market Surveillance Requirements of the EU MDR: Implementation Challenges and Solutions
Wednesday, 16 September 2020
10:35 – 11:30 a.m. EDT
Panelists in this session will go into detail about strategies to overcome audit findings and gaps in your evidence. If you want to help optimize every element of PMS/PMCF as it relates to the EU MDR at your organization, this is the definitive session for you. The panel discussion is designed for every attendee to leave with the ability to impact their organizations. You’ll learn from people who have truly been there and done that.
Our panel:
- Caroline Byrd – Director Commercial RA/QA, Leica Biosystems Richmond, Inc.
- Ibim Tariah, Ph.D. – Vice President of EU MDR and IVDR Consulting Services, R&Q
- Anjali Atal-Gupta, M.Ed, RAC (US, EU, Device) – Senior Manager, Regulatory Affairs, Stryker Neurovascular
- Amie Smirthwaite BEng, Ph.D. – Senior Director, Global Clinical Practice, Maetrics
- Jon Gimbel, Ph.D. – Executive Director, Regulatory & Quality Consulting Services, R&Q
See the session and expanded description on the RAPS Convergence agenda.
Please note panelist information at link may not be up to date.
Virtual Booth #206
Stop by the R&Q virtual booth to say "hi" (RAPS has a video chat feature coming soon!) and for the opportunity to meet our team of experts and featured panelists. We'll be adding a lot more information to our virtual booth as the Convergence approaches. It will be stocked full of new, timely, and free resources made available exclusively throughout the conference and tailored specifically for the RAPS Convergence audience.
For example, here's a sneak peek of the areas we'll be focusing on as part of our Product Showcase:
- All Things EU MDR and IVDR (includes CERs and PERs)
- PMCF Surveys
- U.S. FDA Regulatory, Quality, and Compliance Support
- R&Q Careers and Culture
- Upcoming and On-Demand Education (our Resources page - subscribe here)
Following our sessions we're planning to direct attendees to our booth for bonus Q&A. Our giveaway is a Gucci padlock "GG Supreme" purse; a beautiful structured shoulder bag complete with a working lock. It's valued at a whopping $1,980 USD and we'll be sharing more details on how to win it soon!
All in all, R&Q is predictably thrilled for this year's RAPS Convergence... and you just read the biggest reasons why. Some final ideas for you as we eagerly wait for the conference:
- Submit your email address above to be notified when the RQM+Live! #18 recording is available
- Browse the R&Q Resources page for upcoming and on-demand content you're interested in
- Like what you see? Subscribe
- Subscribe to our Device Love Podcast on your podcast platform of choice (search "device love")
- Follow us on LinkedIn
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