RAPS Texas Chapter: Communicating Benefit-Risk Is Fundamental to Device Approval and Market Adoption

Come engage with professionals from your local regulatory community over dinner and hear an interactive presentation on communicating benefit-risk analysis seeking approval of a medical device. This event is coordinated by the RAPS Texas Chapter and is intended to encourage knowledge sharing and community development. A meal will be provided. RAC holders may claim 1.5 RAC recertification credits.

While demonstrating safety and effectiveness is important, sponsors may be missing an even more important question. That is, “Does the benefit outweigh the risk?” The FDA guidance on Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications provides clear direction from FDA on the framework for assessing benefit-risk.

Developing key benefit-risk messages and communicating them effectively are critical in marketing applications, advisory panels and technology assessment committees. A thorough benefit-risk assessment is the foundation for the messages surrounding unmet need, proposed indication, patient population, clinical trial results and broader clinical application. Importantly, this data can provide the cost-benefit evaluation to make reimbursement decisions. The FDA framework considers factors such as the type, magnitude, duration, and probability of benefits; the nature of adverse events and device complications; disease characteristics; patient tolerance for risk; and the availability and benefit-risks of alternative therapies.




  • At a Glance
  • Objectives
  • Agenda
  • Speaker
  • Registration Info
  • Cancellation

At a Glance

Date:

Wednesday, 17 May 2017  (6:00–8:00 pm CDT) 

Location:

Emergo Group Headquarters 
2500 Bee Cave Road, Building One,
Conference Room B120
Austin, TX 78746 

Directions are available online or by calling +1 521 222 0262.

RAC Credits:

1.5 RAC certification credits upon completion of the program 

Registration Fees:

Prior to 10 May 2017:
RAPS Members: $30      
List: $45

On or after 10 May 2017:
RAPS Members: $40     
List: $55

Objectives

Upon the presentation’s conclusion, you should be able to:

  • Identify the factors that comprise the benefit-risk assessment
  • Develop key messages necessary to communicate a positive benefit-risk
  • Tailor the benefit-risk messages to each key audience: FDA, advisory panel, payer, patient and health-care-practitioner

Agenda

Wednesday, 17 May 2017 (6:00–8:00 pm CDT)

6:00–6:30 pm          Registration, Networking and Refreshments
6:30–8:00 pm          Speaker Presentations and Q/A Session

Speaker

Todd Gross, PhD, 3D Communications 

Registration Info

Prior to 10 May2017
RAPS Members: $30      
List: $45

On or after 10 May 2017:
RAPS Members: $40     
List: $55

>> Registration Online

>> Registration Form (PDF) – for registration by mail or fax.

Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contact

Trilo Das, chair, RAPS Texas Chapter

Wesley Carr, senior program manager, chapter and volunteer relations, RAPS

 

 

 

Cancellation

Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.