Document 05.02
Ref. Ares(2019)7622862 - 11/12/2019
EFPIA Medicines for Europe FMD (Falsified Medicines Directive)
Location: Crowne Plaza Brussels - Le Palace, Rue Gineste 3, B-1210 Bruxelles 8th floor
Date and time: Wednesday 4 December 2019, 11.00-17.00
Expected number of participants: +/- 80
Timing Agenda Agenda Item
Chair/Speaker
Item
Number
11:00
1.
Objectives and expected deliverables of the joint
(AZ)/
workshop with participation of representatives from
(Medicines for
EAEPC, GIRP, PGEU, EAHP, HOPE and EMVO
Europe)
a) Anti-trust guidance
b) Roll call of participants
c) Introductory remarks by co-chairs Review of
key agenda items & outline of expected
deliverables from the workshop
11:15
2.
EMVO Operations update
(EMVO)
Hub Release Roadmap
Hub Release 1.6
Hub Release 1.7
Alert Quality Management
NCA Reports Status
Incidents Status
Q&As Next steps
12:00
3.
European Alert Management System
(NL
NMVO)
a) Update from working group
b) Q&As Next Steps
12:30
4.
End of stabilization periods
(Medicines for Europe)
a) What does it mean in practice for product flows?
b) Implications for supply chain actors? For the
EMVs?
c) Q&As Next steps
13:00
Lunch and Networking
14:00
5.
-as-
(EMVO)
Report
a) Intent and contents of the report
b) Review of first draft
c) Using the report moving forwards
d) Q&As Next Steps
14:30
6.
NMVO fee model (and level) in 2020
(EMVO)
a) Review of available information
NMVOs
b) Misalignments between fee levels and reality on
the ground?
c) Q&As Next Steps
15:00
7.
EMVS Change Control Board
(EMVO)
a) What is it? What does it serve?
b) Interactions with TEAG and role of TEAG
c) Status update
d) Q&As Next steps
15:30
Coffee break
16:00
8.
EMVO views on FMD workshops in 2020
(EMVO)
a) Format of meetings
b) High-level priorities for 2020
c) Q&As Next steps
16:50
9.
Summary of conclusions and review of next steps
(AZ)/
(Medicines for
Europe)
17:00
Close
EFPIA Medicines for Europe
MR AVH/ 28.11.2019