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EMVO FMD WorkshopBrussels 13. December 2016
State of Play – HUB Onboarding
Markus Gerigk
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Pharmacy
System
Wholesaler
System
National
Standalone
System
Pharmacy
System
Wholesaler
System
Inte
rface
Pa
ral. D
istr
. In
terf
.
Inte
rfa
ce
Ma
n. In
terf
.
Nat Syst. Interf.
Interface
Manufacturer
System
European
Hub
Parallel
Distributor
System
Nat. Blue Pr. Interf.
Wholes. Interf.
Nat. Blueprint.
Interf.
Interface
System owner =
Manufacturer
System owner =
Parallel DistributorSystem owner = EMVO
System owner =
NMVO
System owner =
Pharmacist
System owner =
NMVO
System Landscape
System owner =
Pharmacist
System owner =
Wholesaler
National System
based on ‘blueprint
standard’
Pharm. Interf.
Interface
Pharmacy Wholesaler
Interface Interface
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Content
3
Next Steps and Support
National Systems
Onboarding Process
Status Manufacturer Onboarding
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Statistics Contractual Onboarding
Onboarding Webinars: 3
Participants up to: 400
Over all Onboarding requests: 100
Signed NDAs: 60
Exponential increase expected in Q1 2017
4
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
EU Hub Environments
5
IQE environment
• Integrated Quality
Environment
• Used for Quality- &
Certification testing by
multiple OBP’s
• Validated environment
PRD environment
• Productive Environment
• Validated environment
ITE IQE PRD
ITE environment
• Integrated Test
Environment
• Used as sandbox by
multiple OBP’s
• Integration testing of
OBP’s connection
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Onboarding Statistics
6
ITE = Test EnvironmentIQE = Quality EnvironmentPRD = Productive Environment
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
OBP COBP BOBP A
7
Dir
ec
t C
on
nec
tio
n
Connection Types
Gateway
Provider X
Gateway
Provider Y
Client a Client b Client c Client d
Ga
tew
ay
Co
nn
ec
tion
2
Ga
tew
ay
Co
nn
ec
tion
3
EU Hub
Ga
tew
ay
Co
nn
ectio
n 1
Ga
tew
ay
Co
nn
ec
tion
2
Ga
tew
ay
Co
nn
ec
tion
3
Ga
tew
ay
Co
nn
ectio
n 1
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Content
8
Next Steps and Support
National Systems
Onboarding Process
Status Manufacturer Onboarding
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Relationship OBP* and EMVO
9
Marketing Authorization Holders (MAH)
EMVO
EU Hub
OBP
Client
Production 1 Production 2
Marketing Authorisation Holder A
Marketing Authorisation Holder B
Production 3 (CMO)
Marketing Authorisation Holder C
Collects datafrom and for
* Onboarding Partner
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Onboarding Contracts
10
Covers provision of Confidential Information by EMVO, e.g. on
European Hub
Gateway
SDK
Purpose: Assessment of participation in the EMVS project
1. Non-Disclosure Agreement
Contractual framework for participation in the On-boarding project, e.g.
Use of Gateway
Interface development
Connect to the HUB
Purpose: Execution of Technical Onboarding
2. Participation Agreement
No ContractNegotiation
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Onboarding Process
11
1) Participation Request
• Initial Contact
• Portal registration
• Non-Disclosure Agreement
2) Legitimacy Check
• Level 1 checks
• Person checks
• (more detailed checks if necessary)
3) Contractual/ Commercial On-
boarding
• Onboarding Fee payment
• Connection Request
• Participation Agreement
4) Technical On-boarding
• System Connection
• System Testing
• System Operation
Managed and administered
by the EMVO’s Commercial
and Partnership
Management Team
Managed by the EMVO’s Operations
Team & Solidsoft Reply
Managed by EMVO
and supported by IMS*
NDA
CAR
PA
CRF
Ticket
*in negotiations
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Legitimacy Check
12
Information received
through Portal (CAR form)
Level 1 checks by 3rd
party
Level 2 checks by 3rd party
Proceed with next steps of onboarding
process
STOP Onboard
ing process
Audited by EDQM in Q1 2017
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Onboarding Fee
13
On-
boarding
Fee
OBPs with more than 12 MAHs in Europe 20,000 €
OBPs with 6 to12 MAHs in Europe 10,000 €
OBPs with 3 to 5 MAHs in Europe 8,000 €
OBPs with 2 MAHs in Europe 6,000 €
OBPs with 1 MAH in Europe 3,000 €
One-Time Fee per OBP
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Content
14
Next Steps and Support
National Systems
Onboarding Process
Status Manufacturer Onboarding
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Onboarding Partner Portal
OBP collaborates with EMVO via Portal
Each OBP requests Portal login credentials via website
OBP supplies specific information via Portal to EMVO
OBP guided through all steps of the Contractual- and Technical Onboarding
OBP Legitimacy Check managed by Quintiles IMS as part of Contractual Onboarding
Portal reports on Onboarding progress of OBP‘s
Planned GO Live date of OBP Portal 07/02/2016
15
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Onboarding Partner Portal
16
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Onboarding Partner Portal
17
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Onboarding Info Package
Guideline
NDA
Participation Agreement
Presentation on „How to get Onboarded“
Can be downloaded Q1 2017
www.emvo-medicines.eu
18
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
NCA Support
Use national registers to inform all national manufacturers
Use EMVO Info Package and EMVOs web page for communication
Feedback to EMVO on national On Boarding progress suggested (NCA via NMVO)
Support of EMVOs manufacturer legitimacy check through national registers
19
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Content
20
Next Steps and Support
National Systems
On Boarding Process
Status Manufacturer On Boarding
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
EMVOs part of NMVS Onboardingeasier…
Numbers
Contacts
IT Provider
Relationship
21
NMVS
32
Known
Known
Cooperation
Manufacturer
2500
Unknown
Unknown
Participation
…but those Late Follower Countriesthat did not even start the technical Workstreammight need support from all sides.
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Requirements for national systems
Principles:
NMVS must be governed and managed by a national stakeholder organisation (NMVO)
National system covers necessary set of use cases
Interface with Hub developed according to EMVO specification
Compliance with security requirements verified by EMVO (audit)
Terms of contract between NMVO and EMVO agreed
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
NCA Support
Call for full participation of all national supply chain partners in governance and system implementation
Suggest support from EMVO to NMVO/national stakeholder where needed
Audit of NMVO/NMVS (by EDQM if appropriate)
23
EMVO FMD Workshop 13. Dec. 2016 – Dr. Markus Gerigk
Conclusion
Guaranteed compliance for Blueprint Solution
European HUB is highly trusted partner
NMVOs profit from EMVOs Legitimacy Check
Manufacturer Onboarding will speed up with Onboarding Portal beginning of 2017
NCA support needed to reach 100% coverage
24
Thank you very much!
Markus GerigkEMVO C&P Management
Contact for On Boarding and general topics: