dd/mm/yyyy

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

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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:

helpdesk@emvo-medicines.eu