Meetings with EU authorities EU authorities - SwAPP
Meetings with EU authorities EU authorities - SwAPP
Meetings with EU authorities EU authorities - SwAPP
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Typical list of meetings PRE-submission<br />
Paediatric Committee hearing<br />
By invitation – free of charge<br />
Large committee<br />
Up to 1 hour./ up to 15 minutes presentation<br />
<br />
<br />
<br />
Scientific Advice meeting<br />
At the discretion of the <strong>authorities</strong> - Only on topics selected by the <strong>authorities</strong><br />
5-28 WP members<br />
1-1.5 hour/15-20 minutes presentation<br />
“follow-up” scientific advice<br />
Not free (regardless of whether there is a meeting)<br />
Pre-submission meeting EMA<br />
About 6 mths before submission – free of charge<br />
5-10 EMA staff<br />
Short presentation on product and development plan<br />
Mainly on procedural aspects<br />
1-1.5 hour<br />
Pre-submission meeting <strong>with</strong> Rapporteurs (x2)<br />
2 months before submission or less – free of charge<br />
3-6 national agency staff<br />
20 minutes presentation followed by Q&A<br />
Company Confidential<br />
Copyright © 2003 Eli Lilly and Company Limited<br />
3<br />
Typical list of meetings POST-submission<br />
<br />
<br />
<br />
Clarification meeting(s)<br />
With Rapporteur(s) and EMA representative<br />
Usually after receipt of questions (d120, d180)<br />
On request<br />
Could be telecon<br />
Variable duration<br />
No extra charge<br />
QRD meeting<br />
CHMP Hearing<br />
By invitations or on request<br />
D181 of the procedure<br />
On outstanding issues<br />
Large committee<br />
1 hour of which 15 minutes presentation<br />
CHMP internal discussion after applicant has <strong>with</strong>drawn<br />
Debrief <strong>with</strong> rapporteur(s)<br />
Company Confidential<br />
Copyright © 2003 Eli Lilly and Company Limited<br />
4<br />
4 th <strong>SwAPP</strong> ExEx Meeting 2011 / 3.3.2011 2
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