Sharing Experiences for Creation of Sufficient Clinical Data

RAC Credits
Virtual Programs Virtual Programs Europe Europe
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

  • 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.

Click here to download the agenda


RAPS Online Workshop Experience

Join from anywhere to advance your continuing education goals and earn RAC credits. Secure and high-quality live online classroom experience. Interactive tools to foster collaboration. Peer-to-peer engagement and support from instructors.

Cancellation Policy: All cancellation requests must be submitted in writing to 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 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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