M-CERSI EVENTS

Event Information

CERSI Workshop: Drug Development in Pediatric Heart Failure
Friday, October 27, 2017
8:00 a.m.-5:00 p.m.
FDA's White Oak Campus, located at 10903 New Hampshire Avenue in Silver Spring, MD- Bldg. #31 Great Room
For More Information:
Ann Anonsen
301 405 0285
aanonsen@umd.edu
http://www.cersi.umd.edu/

Mark your calendars for Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints, a one-day public workshop jointly sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA)

Scheduled for Friday, October 27, 2017 from 8:00 a.m. to 5:00 p.m. Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints will address challenges related to evaluation of products in pediatric heart failure including population to study, endpoints, extrapolation of adult efficacy data, innovative trial designs and statistical methods. The workshop will provide an opportunity for relevant stakeholders, including representatives from academia, government, non-profit organizations, and industry, to discuss similarity of heart failure between adults and pediatric patients, trial design considerations, and use of innovative statistical and modeling approaches. Specifically, the workshop will include:

  • Presentations on clinical manifestation and management of heart failure in pediatric patients as compared to adults
  • Discussion of alternative approaches to establishing efficacy including extrapolation of adult efficacy data, pharmacokinetic/pharmacodynamic endpoints, clinical endpoints, and innovative trial designs.

This event will be held at the FDA's White Oak Campus, located at 10903 New Hampshire Avenue in Silver Spring, MD. It will take place in Building 31, Great Room.

Current Agenda

The goal of the workshop is to address challenges related to evaluation of products in pediatric heart failure including population to study, endpoints, and extrapolation of adult efficacy data. The workshop will also provide a forum for discussion on the use of registry data as well as alternative trial designs and statistical methods. 

View the full agenda online via the event website

 

Registration Fees: 

The cost to register for this event is determined by the participant type. Please review the fee structure provided below to determine if you will be require to submit a payment with your registration. 

  • UMB and UMCP Faculty, Staff, and Students: FREE
  • Federal Government Employees: FREE
  • Non-Profit Organizations and Academia Representatives (Excluding the University of Maryland): $50.00
  • Industry Representatives: $50.00

 

 Webcast Streaming:

This public workshop will also be available to view via webcast. There is no registration fee for individuals who want to access the workshop via the webcast, but registration is still required.
 

The Webcast link:

 

 https://collaboration.fda.gov/e3b3tzvg8na/event/registration.html

 

If you have never attended a Connect Pro event before, please test your connection here.

 

 

How to Register:

To attend this event in-person, please register online via the event website.

Non-FDA Attendees

If you register as a webcast attendee, the webcast link will be provided to you by e-mail after you have registered for the workshop.

Accommodations

Attendees are responsible for their own hotel accommodations. For a complete list of local hotels please visit the FDA website.

For more information, please email Yeruk (Lily) Mulugeta.

 

 


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