THE EUROPEAN MEDICINES VERIFICATION ORGANISATION

Transcription

1 THE EUROPEAN MEDICINES VERIFICATION ORGANISATION ONBOARDING PROCESS EMVO GATEWAY André Geraldes Operations

2 THE ONBOARDING PROCESS 2

3 PARTICIPATION REQUEST

4 ON-BOARDING PARTNER PORTAL Step 1: Provide Initial Information Step 2: Participation Agreement + Detailed information Step 3: Approvals Step 4: Technical On Boarding 4

5 STEP 1: PROVIDE INITIAL INFORMATION Trigger step 1: Successful Request to Participate To add or modify the requested information Estimated time to complete Status: Not Started In Progress Complete Optional step 5

6 ON-BOARDING PARTNER PORTAL Step 1: Provide Initial Information Step 2: Participation Agreement + Detailed information Step 3: Approvals Step 4: Technical On Boarding 6

7 STEP 2: DETAILED INFORMATION AND PARTICIPATION AGREEMENT Trigger step 2: Successful Initial Information and Authorise Representative copy of proof Download General Info Pack Status: Not Started Completed View and Download prefilled Participation Agreement (PA) Status: Not Started Awaiting Approval Approved Rejected A sample of the PA is available on our website in its download section. Status: Not Started Completed 7

8 PARTICIPATION AGREEMENT The Participation Agreement (PA) 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 8

9 ON-BOARDING FEE 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, % 30, % 45, OBP with 6 to 12 MAHs 10, , , OBP with 3 to 5 MAHs 8, , , OBP With 2 MAHs 6, , , OBP with 1 MAH 3, , ,

10 2.8 CONFIRM ALL INPUTTED INFORMATION By clicking on the Confirm button the SPOC confirms the accuracy of the information provided on the portal. This triggers the Legitimacy Check. 10

11 LEGITIMACY CHECK o Around 50 parameters checked o Direct and indirect checks are conducted o Outsourced: conducted totally independently from EMVO ensuring efficiency, accuracy and objectivity 11

12 ON-BOARDING PARTNER PORTAL Step 1: Provide Initial Information Step 2: Participation Agreement + Detailed information Step 3: Approvals Step 4: Technical On Boarding 12

13 STEP 3: APPROVALS Trigger step 3: Step 2 completed and confirm button pressed. Status: Not Started Passed Failed Status: Not Started Awaiting hardcopy Sent back on xx:xx:xxxx Status: No Status Awaiting payment Payment received 13

14 ON-BOARDING PARTNER PORTAL Step 1: Provide Initial Information Step 2: Participation Agreement + Detailed information Step 3: Approvals Step 4: Technical On Boarding 14

15 STEP 4: TECHNICAL ON-BOARDING Purpose: 1. Facilliate all technical documentation 2. Generate Connection Pack to enable a connection to the EU HUB 3. Perform basic tests to the OBP s interface 15

16 STEP 4: TECHNICAL ON-BOARDING Trigger step 4: Step 3 completed 16

17 STEP 4.1 TECHNICAL INFOPACK All necessary Technical Documentation to establish a Connection to the EU Hub is available in this step Status: Not Started Completed 17

18 STEP 4.1 TECHNICAL INFOPACK - OVERVIEW 18

19 STEP CONNECTION DETAILS Provide information about the interface used to connect to the EU Hub 19

20 STEP CONNECTION DETAILS 20

21 STEP CONNECTION DETAILS 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.

22 STEP CONNECTION DETAILS Possibility to select a Registered Gateway Provider or Sponsor a new one. 22

23 STEP CONNECTION DETAILS Displays the list of Gateway Providers that already signed a contract with EMVO and Solidsoft (Registered Gateway Providers) 23

24 STEP CONNECTION DETAILS Requested Information to Sponsor a new Gateway Provider. EMVO will contact the sponsored company to sign a contract. 24

25 STEP CONNECTION DETAILS EMVO will not provide technical support if the OBP decides to use a different technology. 25

26 EU HUB ENVIRONMENTS ITE IQE PRD ITE environment Integrated Test Environment Available only for Direct Connections Gateway providers have a dedicated environment with Solidsoft IQE environment Integrated Quality Environment Used for validation and baseline testing. PRD environment Productive Environment Validated environment 26

27 STEP ITE 27

28 STEP INFORMATION TO CREATE CSR 28

29 STEP INFORMATION TO CREATE CSR Necessary information to create a CSR file: Common Name = Company Type. Organisation ID. Client ID 29

30 STEP CREATING A CSR USING OPENSSL Instructions on how to create a CSR file are available in Step EMVO 0117 Creating CSR files document Note: When creating a CSR file a KEY file is also generated Keep this file in a safe location 30

31 STEP UPLOAD CSR FILE Upload the CSR file generated in the previous step. An automatic check of the file will occur in the HUB. Note: The EU Hub will only check the Common Name provided 31

32 STEP CERTIFICATE 32

33 STEP CERTIFICATE Public and Client Certificates are available to download Endpoints are displayed 33

34 STEP SESSION TOKEN When this step is reached, a request for a Session Token will be sent to EMVO. Note: This is not an automated step. EMVO will manually provide a Session Token usually the same day. 34

35 STEP SESSION TOKEN The Session Token will be displayed by clicking the Info button 35

36 STEP TEST STATUS METRICS Optional Step (in ITE) that will allow the OBP to check if the transanctions between the OBPs Interface and EU Hub are successful 36

37 STEP IQE The same process applies for all steps of IQE, except that the Test Status Metrics are mandatory. 37

38 EMVO GATEWAY CREDENTIALS Complete all IQE Steps until Certificate Generate a PFX file (instructions in document EMVO 0117 Creating CSR Files. Send an to the Helpdesk with the following information: 1. PFX File 2. PFX Password 3. SPOC Name 4. SPOC The SPOC will receive an from noreply@meliorsolutions.com with credentials and URL to access the EMVO Gateway 38

39 STEP TEST STATUS METRICS (BASELINE TESTS) 39

40 STEP TEST STATUS METRICS (BASELINE TESTS) OBP should use their Connection to upload data to the EU Hub. The OBP Portal will display if the transactions were successfull. 40

41 STEP TEST STATUS METRICS (BASELINE TESTS) Example: A Product Master Data was successfully uploaded. OBP Portal displays this dimension as Passed 41

42 STEP TEST STATUS METRICS (BASELINE TESTS) 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 42

43 STEP TEST STATUS METRICS (BASELINE TESTS) 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. 43

44 STEP TEST STATUS METRICS (BASELINE TESTS) 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. 44

45 STEP PRD OBP will have access to PRD steps as soon as the Test Status Metrics were approved by EMVO. 45

46 STEP 4.3 CLIENT CONNECTION 2 Technical Onboarding for Connection 2 can be done at the same time as Connection 1. 46

47 VISIT OUR KNOWLEDGE DB FOR MORE INFORMATION 47

48 THE EMVO GATEWAY 48

49 WHAT IS THE EMVO GATEWAY? 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. 49

50 WHAT IS THE EMVO GATEWAY? OBP EMVO Gateway Web Application European Hub OBP OBP OBP OBP https web- Interface OBP web-service Interface National Systems 50

51 WHAT CAN THE EMVO GATEWAY DO? 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. 51

52 WHAT THE EMVO GATEWAY IS NOT 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). 52

53 SCREEN SAMPLES o EMVO Gateway Home Screen (Landing Page) 53

54 SCREEN SAMPLES o Organisational Data View 54

55 SCREEN SAMPLES o Manufacturing Source Data View 55

56 SCREEN SAMPLES o Results View 56

57 QUESTIONS? 57