PATIENT REPORTED OUTCOMES 2013: DEVELOPMENT AND APPLICATION
13th June, 2013
Time: 08:30 - 17:30
Location: Sofitel Hotel, Heathrow, London Time: 08:30 - 17:30
Timezone: (GMT) Western Europe Time, London, Lisbon, Casablanca
A new 1-day course offered to those with an interest in the construction and use of patient reported outcomes (PROs) in the development, assessment and reimbursement of medicines. This is an intermediate course suitable for novices and experienced participants alike, and will have relevance to international participants from academia, health care providers, as well as the pharmaceutical, regulatory and device development industries.
Course objectives
- Understand the scope and range of PRO measurement and ascertain how PROs support medicine and device development and approval in the EU and US.
- Understand the key considerations when selecting a PRO for a particular use and be able to evaluate a PRO accordingly.
- Develop an understanding of the steps required to develop and validate a PRO, and ensure translatability in additional language and electronic formats.
- Gain awareness of regulatory requirements from EMA/ FDA, the needs of NICE regarding PROs and the use of PRO data by other decision makers.
http://www.iconplc.com/news-events/events/workshops/patient-reported-outcomes/index.xml
No comments:
Post a Comment