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2017 RAPS Regulatory Convergence

September 9 @ 08:00 - September 12 @ 17:00 UTC+0

Save the date! Join our experts @ #RAPS2017 Sept. 9-12 @ Booth #629 - Contact us with any questions


Mapi will participate in RAPS 2017 Regulatory Convergence activities this fall at the Gaylord National Resort & Convention Center in National Harbor, MD.

The Regulatory Convergence is RAPS’ annual multi-day gathering of the global regulatory community. Attending this event is the perfect opportunity for clients to meet and discuss with some of our experts/specialists.  "Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators - This is where it all comes together."

We invite you to take advantage of this scenario by pre-scheduling an on-site meeting with one or more of our attending experts from Mapi's Strategic Regulatory Services team, during which you can share your needs and ideas with us and we'll offer insights and advice in return: click here to arrange a consultation or email your meeting request to webinquiry@mapigroup.com.

Mapi's Event Role:

Speakers/Presentations -

Silvia Bendiner - Director, Business Development, Strategic Regulatory Services (SRS) - Latin America, Mapi

  • Two 90-minute Panel Discussions Moderator
  • Presentation Dates/Times: Monday, 11 September, 2017 - Time specifications coming soon!
  • Topics: Coming soon!
  • Descriptions: Coming soon!

Shirley Furesz, PhD, RAC (Canada) - Associate Director, Regulatory Affairs - Medical Devices, Strategic Regulatory Services, Mapi

  • Session Leader
  • Topic: “Global Regulatory Landscape for Laboratory Developed Tests (LDTs)”

Roshana Ahmed - Associate Director, Regulatory Affairs - Medical Devices, Strategic Regulatory Services, Mapi

  • Session Leader
  • Topic: "EU MDR and IVDR: Overview"
  • Description: Publication of the EU Medical Device Regulations is expected in Q2 2017 with compliance required by 2020. Given the extent of changes, manufacturers need to start planning now to meet the new requirements. Key takeaways: -Provide a summary of major changes between the Medical Device Directive and Regulation, including differences between the proposed and final text; highlight timelines for implementation -Notified Body expectations of manufacturers, expected challenges, timelines, readiness to audit, impact of Brexit on the CE Marking process -Industry perspectives on the planning process and unexpected challenges during the transition process -Impact on legacy directive products and re-accreditation of legacy product based on post market data -Periodic Safety Update Report and harmonization of reporting process

* Note: This list is subject to change/updates.


Register to attend:

https://www.raps.org/cr.aspx?id=27018

Details

Start:
September 9 @ 08:00
End:
September 12 @ 17:00
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