|
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Marketing Status reporting implementation plan and baseline requirements
|
Roberta Bernardelli
|
|
1 |
|
|
Request protocol assistance for one molecule under multiple ODDs
|
Stephanie Pham
|
|
1 |
|
|
Essential maintenance to the IRIS Portal and IRIS Case Management Portal – 12 April 2021
|
Sara Teiken
|
|
0 |
|
|
Variations
|
Erik Grimmelihuysen
|
|
1 |
|
|
IRIS Industry Contributor
|
Tanya Konovalenko
|
|
1 |
|
|
Has my SA submission been accepted? Awaiting Validation of Scientific Advice?
|
Gioia Riboni Verri
|
|
1 |
|
|
Status of Submission - Scientific Advice
|
Shilpa Jain
|
|
1 |
|
|
MAA field in the Procedural Information section of the SA IRIS form
|
Ian Hardern
|
|
1 |
|
|
Accidentally withdrawing an RPI request - help with next steps
|
Caroline Langham
|
|
1 |
|
|
Follow up Scientific Advice - Reference to previous Scientific Advice
|
Petra Bettendorf
|
|
3 |
|
|
SA request submission by co-development partner
|
Ian Hardern
|
|
6 |
|
|
Harmonize submissions of orphan designation annual reports
|
Tina Kling
|
|
1 |
|
|
Submitting annual report in orphan designation
|
Dorte Dyregaard
|
|
3 |
|
|
Non-EU based consultants
|
Luisa Pachés-Samblás
|
|
5 |
|
|
Use of regulatory consultants
|
Luisa Pachés-Samblás
|
|
2 |
|
|
Technical specification
|
Susanne Hense
|
|
5 |
|
|
Marketing Status Reporting
|
Susanne Hense
|
|
2 |
|
|
Scientific advice in IRIS- Applicant and linked organisation information
|
Rainer Paffenholz
|
|
1 |
|
|
Scientific Advice follow up submission
|
Liron Gibbs-Bar
|
|
3 |
|
|
draft briefing document
|
Markas Marcinkevicius
|
|
3 |
