CRED ERP 25

First page Table of contents Next page Last page
Cover1
Programme2
Speaker Biographies6
Quick Reference Guide9
QRG -DCP10
QRG- CP11
QRG-Legal Basis13
QRG - MRP14
Pre - Read16
Pre-read: Centralised Procedure16
Pre-read: Decentralised and MRP30
Pre-read: Legal bases, application types, non NCEs52
DAY 161
Overview of the European Regulations61
Developing your Global Filing Strategy98
Developing Strategy for Filing Non-NCEs111
Decentralised and Mutual Recognition Procedures133
Finalising your European Regulatory Strategy155
Appendix 1- Biosmilars in the EU177
Appendix 2 -EC OF THE EUROPEAN PARLIAMENT217
Appendix 3 - EMA223
Appendix 4- EMA245
Case study- DAY 1262
DAY 2264
Key EU Regional Considerations264
Centralised Procedure - The Details282
Agency perspective on strategic and practical considerations – how to work effectively302
Case study -D2342
Slide 1: New Marketing Authorization Application 'S In The Centralised Procedure329
Slide 2329
Slide 3: SCOPE OF CENTRALISED PROCEDURE330
Slide 4: STEPS PRIOR TO SUBMITTING AN APPLICATION330
Slide 5331
Slide 6331
Slide 7: SUBMISSION OF THE APPLICATION332
Slide 8: ASSESSMENT OF THE APPLICATION332
Slide 9: EUROPEAN COMMISSION DECISION ON THE MARKETING AUTHORISATION333
Slide 10: NEW MARKETING AUTHORIZATION333
Slide 11334
Slide 12: THEORY IN REAL LIFE334
Slide 13335
Slide 14335
Slide 15: EMA COMMITTEES – MAIN TASKS336
Slide 16336
Slide 17337
Slide 18337
Slide 19338
Slide 20: ORPHAN DRUG DESIGNATION338
Slide 21339
Slide 22: EXCLUSIVITY FOR ORPHAN PRODUCTS339
Slide 23340
Slide 24340
Slide 25341
Slide 26: REFERENCES341

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