onboarding and emvo gateway presentation andré... · 2018. 4. 13. · microsoft powerpoint -...

THE EUROPEAN MEDICINES VERIFICATION ORGANISATION

ONBOARDING PROCESSEMVO GATEWAY

André GeraldesOperations

THE ONBOARDING PROCESS

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PARTICIPATION REQUEST

https://emvo-medicines.eu/pharmaceutical-companies/obp-portal/

ON-BOARDING PARTNER PORTAL

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Step 2: Participation Agreement + Detailed information

Step 3: Approvals

Step 1: Provide Initial Information

Step 4: Technical On Boarding

STEP 1: PROVIDE INITIAL INFORMATION

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Estimated time to complete

To add or modify the requested information

Trigger step 1:Successful Request to Participate

Status: Not StartedIn ProgressComplete

Optional step


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Step 3: Approvals



STEP 2: DETAILED INFORMATION AND PARTICIPATION AGREEMENT

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Download General Info Pack

Status: Not StartedAwaiting ApprovalApprovedRejected

Status: Not StartedCompleted

Status: Not StartedCompletedA sample of the PA is available on our website in its download section.

View and Download prefilled ParticipationAgreement (PA)

Trigger step 2:Successful Initial Information andAuthorise Representative copy of proof

PARTICIPATION AGREEMENT

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Participation of the OBP in the Onboarding Project

Access to Software Development Kits

Right to Develop an OBP Interface

Right to upload data to the EU HUb

Usage of the EMVO Gateway

The Participation Agreement (PA)

ON-BOARDING FEE

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One-Time Fee per OBP

Early Bird on-boarding Fee From the 15th of January 2018 From the 15th of June 2018

OBP with > 12 MAHs € 20,000.00 € 30,000.00 € 45,000.00

OBP with 6 to 12 MAHs € 10,000.00 € 15,000.00 € 22,500.00

OBP with 3 to 5 MAHs € 8,000.00 € 12,000.00 € 18,000.00

OBP With 2 MAHs € 6,000.00 € 9,000.00 € 13,500.00

OBP with 1 MAH € 3,000.00 € 4,500.00 € 6,750.00

+50% +50%

2.8 CONFIRM ALL INPUTTED INFORMATION

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By clicking on theConfirm button the SPOC confirms theaccuracy of theinformation provided on theportal.This triggers theLegitimacyCheck.

LEGITIMACY CHECK

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o Around 50 parameters checked

o Direct and indirect checks are conducted

o Outsourced: conducted totally independently from EMVO –ensuring efficiency, accuracy and objectivity


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Step 3: Approvals



STEP 3: APPROVALS

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Status: Not StartedPassedFailed

Trigger step 3:Step 2 completed andconfirm button pressed.

Status: Not StartedAwaiting hardcopySent back on xx:xx:xxxx

Status: No StatusAwaiting paymentPayment received


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Step 3: Approvals



STEP 4: TECHNICAL ON-BOARDING

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Purpose:

1. Facilliate all technical documentation

2. Generate Connection Pack to enable a connectionto the EU HUB

3. Perform basic tests to the OBP’s interface

STEP 4: TECHNICAL ON-BOARDING

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Trigger step 4:• Step 3 completed

STEP 4.1 TECHNICAL INFOPACK

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All necessary Technical Documentation to establish a Connection to the EU Hub is available in this step

Status: Not StartedCompleted

STEP 4.1 TECHNICAL INFOPACK - OVERVIEW

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STEP 4.2.1 CONNECTION DETAILS

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Provide information about the interface used to connect to the EU Hub


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Direct Connection:

OBP uses internal department to develop connection or hires an IT service provider that will work exclusively with this OBP.

Gateway Connection:

OBP uses an IT Service Provider that will establish connections to the EU Hub for multiple OBPs.


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Possibility to select a Registered Gateway Provider or Sponsor a new one.


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Displays the list of Gateway Providers that already signed a contract with EMVO and Solidsoft (Registered Gateway Providers)


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• Requested Information to Sponsor a new Gateway Provider.• EMVO will contact the sponsored company to sign a contract.


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EMVO will not provide technical support if the OBP decides to usea different technology.

EU HUB ENVIRONMENTS

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IQE environment• Integrated Quality

Environment • Used for

validation andbaseline testing.

PRD environment• Productive

Environment• Validated

environment

ITE IQE PRD

ITE environment• Integrated Test

Environment• Available only for

Direct Connections• Gateway providers

have a dedicatedenvironment withSolidsoft

STEP 4.2.2 ITE

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STEP 4.2.2.1 INFORMATION TO CREATE CSR

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STEP 4.2.2.1 INFORMATION TO CREATE CSR

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Necessary information to create a CSR file:Common Name = Company Type . Organisation ID . Client ID

STEP 4.2.2.1 CREATING A CSR USING OPENSSL

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Instructions on how to create a CSR file are available in Step 4.1 -EMVO 0117 Creating CSR files document

Note:When creating a CSR file a KEY file is alsogenerated –Keep this file in a safe location

STEP 4.2.2.2 UPLOAD CSR FILE

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Upload the CSR file generated in the previous step. An automaticcheck of the file will occur in the HUB.

Note:The EU Hub willonly check the Common Name provided

STEP 4.2.2.3 CERTIFICATE

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STEP 4.2.2.3 CERTIFICATE

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• Public and Client Certificates are availableto download

• Endpoints are displayed

STEP 4.2.2.4 SESSION TOKEN

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When this step is reached, a request for a Session Token will be sent to EMVO.

Note:This is not an automated step. EMVO willmanuallyprovide a Session Token –usually the sameday.

STEP 4.2.2.4 SESSION TOKEN

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The Session Token will be displayed by clicking the ‘Info’ button

STEP 4.2.3.5 TEST STATUS METRICS

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Optional Step (in ITE) that will allow the OBP to check if the transanctions between the OBPs Interface and EU Hub are successful

STEP 4.2.3 IQE

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The same process applies for all steps of IQE, except that the Test Status Metrics are mandatory.

EMVO GATEWAY CREDENTIALS

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• Complete all IQE Steps until 4.2.3.3 – Certificate• Generate a PFX file (instructions in document EMVO 0117 Creating

CSR Files.• Send an email to the Helpdesk with the following information:

1. PFX File2. PFX Password3. SPOC Name4. SPOC E-mail

The SPOC will receive an email from [email protected] credentials and URL to access the EMVO Gateway

STEP 4.2.3.5 TEST STATUS METRICS (BASELINE TESTS)

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OBP should use their Connection to upload data to the EU Hub. The OBP Portal will display if the transactions were successfull .


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Example:A Product Master Data was successfully uploaded. OBP Portal displays this dimension as ‘Passed’


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Mandatory Test Dimensions to have access to PRD:• Product Master Data• Product Pack Data • Product Pack Update

Optional dimensions to test:• Product Pack Verification • Report Process


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Important Notes:• All tests of the test status metrics should use product data which is

uploaded in the emulated markets (XX, XY and XZ). • A 30 minutes timeframe is available to execute, check and submit

the test results by clicking the button ‘Submit’ in the OBP Portal. • After the 30 minutes timeframe the status will automatically reset to

‘Failed’ even if the tests were passed and submitted.


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• The IQE Test Status Metrics is only self-awareness tool.• Passing these tests does not mean or imply that the OBP system has

been certified or validated by EMVO.• Validation and DR compliance remains the responsibility of the OBP

in his role as system owner.

STEP 4.2.4 PRD

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OBP will have access to PRD steps as soon as the Test Status Metricswere approved by EMVO.

STEP 4.3 CLIENT CONNECTION 2

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Technical Onboarding for Connection 2 can be done at the sametime as Connection 1.

VISIT OUR KNOWLEDGE DB FOR MORE INFORMATION

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THE EMVO GATEWAY

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WHAT IS THE EMVO GATEWAY?

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o It’s a cost free solution to connect to the EU Hub during the transition period.

o A web-based application requiring no “installed” software -Provides an ‘access anywhere’ system for interactions with the EU Hub.

o Provides a secure cloud-based interface to the EU Hub.

o A fast way to become “connected” to the EU Hub.

o Provides a great means for an OBP to send data to the EMVS for pilot and small-scale production.

OBP

OBP

EMVO Gateway Web Application

WHAT IS THE EMVO GATEWAY?

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European Hub

OBPOBP

OBPweb-service

Interface

National Systems

OBP “https” web-

Interface

WHAT CAN THE EMVO GATEWAY DO?

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o The EMVO gateway allows connected users to:• Upload and maintain master data• Upload and amend batch & pack data• Request reports

o Users can insert data manually (e.g. each pack at a time) or upload data by means of XML/JSON files.

o OBP’s can manage their own users and provide the users with individual roles and permissions.

o The EMVO gateway can be configured to allow an external party (e.g. a CMO) to upload data on behalf of the OBP (using the OBP account).• Note: the liability for allowing any external party to upload or amend data is entirely

that of the OBP granting permission.

WHAT THE EMVO GATEWAY IS NOT

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o It does not generate Serialization data for the packs.

o It has no means of automation available.

o It relies on human interaction.

o For heavy use nor as a primary interface for OBP’s of reasonable annual pack volume / SKU count (specifically because of its manual nature).

SCREEN SAMPLES

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o EMVO Gateway Home Screen (Landing Page)

SCREEN SAMPLES

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o Organisational Data View

SCREEN SAMPLES

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o Manufacturing Source Data View

SCREEN SAMPLES

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o Results View

QUESTIONS?

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onboarding and emvo gateway presentation andré... · 2018. 4. 13. · microsoft powerpoint -...

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