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Sharing Experiences for Creation of Sufficient Clinical Data

6.0
RAC Credits
Tuesday, 08 September 2020 (9:00 AM) - Wednesday, 09 September 2020 (2:00 PM) Eastern Time (US & Canada)
The interactive workshop will begin by briefly reviewing six proven clinical strategies to collect sufficient clinical evidence for currently marketed products and then focus on two that are receiving renewed attention. A risk-based approach is taken to implement clinical plans using Likert clinical surveys and big data hospital networks. They need to be developed correctly and compliantly. Learn what ethics committees, healthcare practitioners, patients and advocacy groups, and regulators and notified bodies expect. Then use cases, tools and worksheets to develop plans and reports, including initial budgets. These two approaches can be used by both medical device and IVD manufacturers.

For all risk classes, clinical surveys and big data, if designed correctly, can be targeted to address specific safety and performance questions or gaps. They need to be scientifically, statistically, and clinically developed with a strong sample size justification, data collection plan and subsequent analysis plan. Learn tips to qualify big data hospital networks. Hear from TÜV-SÜD and BSI, the two largest notified bodies with full MDR/IVDR designations, industry representatives, and consultants as they share their expectations and best practices.

These two clinical strategy methods can be used to either be the primary source of safety and performance data, e.g., for low-risk devices, or they can be used to fill in the gaps for higher risk devices where conducting a clinical investigation or registry is not practical.

Case studies, small group worksheets, polling questions and panel discussions will be used in this interactive workshop. Participants will understand how this safety and performance data can be used to also create benefit-to-risk analyses within the current state-of-the-art of their product. Finally, implications for updating technical documentation files will be reviewed, focusing on seventeen required plans and reports.

Pricing Amounts & Deadlines

6/23/2020 -8/14/2020:  Early Bird $400.00 Member | $500.00 Nonmember

8/15/2020 – 9/5/2020:        Regular $500.00 Member | $600.00 Nonmember


Objectives 
  • Describe five steps to create a Likert clinical survey and explain why two of these steps take the longest time to implement
  • Explain the top five issues to address when accessing big data hospital networks
  • Hear from TÜV-SÜD and BSI, the two largest notified bodies with full MDR/IVDR designation, industry experts, and consultants regarding practical suggestions for implementation


Who Should Attend?

Clinical Affairs, Regulatory Affairs, Regulatory Compliance, Quality, Medical Affairs, Chief Medical Officers, CROs, Consultants, Medical Writers, Biometrics (stats), Project/Program Managers.



Other items: There will be pre- and post-workshop assignments or follow-up to facilitate effective and efficient use of your time.



Agenda

Day 1

9:00 AM:                            Start of the workshop

9:00 - 10:30 AM:           Speaker presentations: Welcome and Workshop Introduction. Six panel members state the problem from their perspective, set expectations, and comment on why we are here today. A review of Likert Survey development and analysis is provided. TÜV-SÜD and BSI, the two largest notified bodies with full designations for MDR and IVDR, share their perspectives. Manufacturer employees and consultant panelist provide practical solutions.

10:30 - 10:45 AM:        15-minute break

10:45 AM - 12 PM:       Speaker presentations: Interactive breakout sessions work on cases to present to panel. Identify targets to develop surveys for.

12:00 - 12:45 PM:         Lunch

12:45 - 2:00 PM            Speaker presentations: Present cases back to panel members who comment on each approach to increase the probability of a successful application. End with a Q&A session. Cases will represent Low Risk IVDs, MD Class 1r, Orthopedic Implants, CV/Peripheral Guidewires, Monitors, Implantable Valves, High Risk IVDs, and a humorous case for Star Wars fans to showcase principles.

2:00 PM:                            End of meeting

 
Day 2


9:00 AM:                         Start of the workshop.

9:00 - 10:30 AM         Speaker presentations: Welcome and Workshop Introduction. Six panel members state the problem from their perspective, set expectations, and comment on why we are here today. A review of Big Data Hospital Networks is provided. TÜV-SÜD and BSI, the two largest notified bodies with full designations for MDR and IVDR, share their perspectives. Manufacturer employees and consultant panelist also provide practical solutions.

10:30 - 10:45 AM       15-minute break

10:45 AM - 12 PM      Speaker presentations: Interactive breakout sessions work on cases to present to panel. Identify targets to develop hospital network strategies.

12:00 - 12:45 PM:       Lunch

12:45 - 2:00 PM           Speaker presentations: Present cases back to panel members who comment on each approach to increase the probability of a successful application. End with a Q&A session.

2:00 PM:                           End of meeting



Speakers

Krishna Medasani, MD, MS, MBA with Natus Medical Devices

Julien Senac, PhD with TÜV-SÜD
Catalina Suarez-Cuervo, MD with Conmed Devices


Cancellation Policy: All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. RAPS will allow substitutions up to the first day of the event.


Program Contact

Stephany Evans
Meeting and Events Specialist
Regulatory Affairs Professionals Society® 
Tel: 301 770 2920, ext. 229
5635 Fishers Lane, Suite 400, Rockville, MD 20852 USA

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