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Table of contents 1.

Table of contents 1. Introduction 6 1.1. Welcome and declarations of interest of members and experts .............................. 6 1.2. Adoption of agenda................................................................................................. 6 1.3. Adoption of the minutes ......................................................................................... 6 2. Applications for orphan medicinal product designation 6 2.1. For opinion ............................................................................................................. 6 2.1.1. - EMA/OD/285/16 ...................................................................................................... 6 2.1.2. - EMA/OD/276/16 ...................................................................................................... 8 2.1.3. - EMA/OD/217/16 ...................................................................................................... 8 2.1.4. - EMA/OD/219/16 ...................................................................................................... 9 2.1.5. - EMA/OD/262/16 ...................................................................................................... 9 2.1.6. - EMA/OD/227/16 .................................................................................................... 10 2.1.7. - EMA/OD/275/16 .................................................................................................... 11 2.1.8. - EMA/OD/261/16 .................................................................................................... 11 2.1.9. - EMA/OD/267/16 .................................................................................................... 11 2.1.10. - EMA/OD/280/16 .................................................................................................... 12 2.1.11. - EMA/OD/289/16 .................................................................................................... 12 2.1.12. - EMA/OD/255/16 .................................................................................................... 13 2.1.13. - EMA/OD/278/16 .................................................................................................... 13 2.1.14. - EMA/OD/266/16 .................................................................................................... 13 2.1.15. - EMA/OD/288/16 .................................................................................................... 13 2.1.16. - EMA/OD/284/16 .................................................................................................... 14 2.1.17. - EMA/OD/234/16 .................................................................................................... 14 2.1.18. - EMA/OD/236/16 .................................................................................................... 14 2.2. For discussion / preparation for an opinion .......................................................... 15 2.2.1. - EMA/OD/201/16 .................................................................................................... 15 2.2.2. - EMA/OD/308/16 .................................................................................................... 15 2.2.3. - EMA/OD/314/16 .................................................................................................... 16 2.2.4. - EMA/OD/299/16 .................................................................................................... 17 2.2.5. - EMA/OD/277/16 .................................................................................................... 17 2.2.6. - EMA/OD/310/16 .................................................................................................... 17 2.2.7. - EMA/OD/265/16 .................................................................................................... 18 2.2.8. - EMA/OD/257/16 .................................................................................................... 18 2.2.9. - EMA/OD/302/16 .................................................................................................... 18 2.2.10. - EMA/OD/204/16 .................................................................................................... 18 2.2.11. - EMA/OD/313/16 .................................................................................................... 19 Committee for Orphan Medicinal Products (COMP) EMA/COMP/50377/2017 Page 2/28

2.2.12. - EMA/OD/270/16 .................................................................................................... 19 2.2.13. - EMA/OD/315/16 .................................................................................................... 19 2.2.14. - EMA/OD/309/16 .................................................................................................... 20 2.2.15. - EMA/OD/287/16 .................................................................................................... 20 2.2.16. - EMA/OD/301/16 .................................................................................................... 20 2.2.17. - EMA/OD/294/16 .................................................................................................... 20 2.2.18. - EMA/OD/293/16 .................................................................................................... 20 2.2.19. - EMA/OD/303/16 .................................................................................................... 21 2.2.20. - EMA/OD/300/16 .................................................................................................... 21 2.2.21. - EMA/OD/286/16 .................................................................................................... 21 2.2.22. - EMA/OD/253/16 .................................................................................................... 21 2.3. Revision of the COMP opinions ............................................................................. 22 2.4. Amendment of existing orphan designations ........................................................ 22 2.5. Appeal .................................................................................................................. 22 2.5.1. 20% I.V. fat emulsion consisting of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection - EMA/OD/062/16 ...................................................... 22 2.6. Nominations ......................................................................................................... 22 2.6.1. New applications for orphan medicinal product designation - Appointment of COMP coordinators ............................................................................................................ 22 2.7. Evaluation on-going .............................................................................................. 22 3. Requests for protocol assistance with significant benefit question 23 3.1. Ongoing procedures ............................................................................................. 23 3.1.1. - ............................................................................................................................ 23 3.1.2. - ............................................................................................................................ 23 3.1.3. - ............................................................................................................................ 23 3.1.4. - ............................................................................................................................ 23 3.1.5. - ............................................................................................................................ 23 3.1.6. - ............................................................................................................................ 23 3.1.7. - ............................................................................................................................ 23 3.2. Finalised letters .................................................................................................... 23 3.2.1. - ............................................................................................................................ 23 3.2.2. - ............................................................................................................................ 24 3.3. New requests ........................................................................................................ 24 3.3.1. - ............................................................................................................................ 24 4. Review of orphan designation for orphan medicinal products for marketing authorisation 24 4.1. Orphan designated products for which CHMP opinions have been adopted .......... 24 4.2. Orphan designated products for discussion prior to adoption of CHMP opinion .... 24 Committee for Orphan Medicinal Products (COMP) EMA/COMP/50377/2017 Page 3/28

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