Create a New Applications Package Set Registration Project

You must create new package set registration applications for each country you specify based on the application category you select.

To create a new applications package set registratoin project:

  1. Click Wizards > Global Project Plan.The GPP wizard opens to the Project Details page.
  2. For the Project Type attribute, select Create New Applications Package Set Registration or a type that maps to the internal project type of Create New Applications Package Set Registration Project as defined in Data Administration.
  3. Enter values for the project attributes. The wizard requires entry for the project type, project name, project status, and project status date.
  4. Click Next.The Select Application Category, Product Family, Products and Countries page appears.
  5. Define criteria for the applications that you want to create:
    1. Select an Application Category from the drop-down list. The application category determines the application type. Application type values are set in Data Administration > Application Maintenance > Application Type Values.
    2. Select a Family Type.
    3. Select a Family Name.
    4. Select one or more Products to associate with the applications you will create.
    5. For Region Type, select the region type that includes the regions with countries for which you want to create applications.
    6. For Region, specify the regions that include the countries for which you want to create applications. The list of available regions is determined by the selected region type. For the European Union region and CP, or WAHO region and CP, or MRP applications, the country you choose will be set as the

      reviewing country.

    7. For the Country attribute, the list of available countries is determined by the selected regions. The list of available countries is further limited to the countries for which you have at least WRITE privileges for the product family you selected, and to the countries with a default procedure type and application type defined for the application category you selected.
  6. Click Next.The Enter Application Details page opens. Regarding this page:

    ◦ The application attributes listed on the page are determined by the XML to which the application type is mapped. Refer to Data Administration > Application Maintenance > Application Type Values for more information.

    ◦ Because you may be creating applications for multiple application types, such a clinical trial is an IND type in the US and a CTA type in the EU, separate screens show the attributes of each different XML to which the application types are mapped.

    ◦ When the applications are created by the wizard, the country code is appended to the value entered in the Application Name and Application Code boxes.

  7. Click Next after completing each Application Details page presented.When all the Application Details pages are completed, the Enter Event Details page opens.
  8. Enter values for the event attributes.An event will be created for each application created by the wizard and the following will occur:

    ◦ For EU-CP applications, the wizard automatically assigns the European Union to the created event.

    ◦ For WAHO-CP applications, the wizard automatically assigns the WAHO country to the created event.

    ◦ For National and MRP applications, the wizard automatically assigns the reviewing country for the event.

    ◦ For MRP applications, the selected countries will be assigned to the created event.

    ◦ For all application types, the event-country status is assigned to each country when the event is created.

    ◦ A Select Timeline/Event Plan page shows for each procedure type for which applications are being created.

  9. From the Timeline/Event Plan drop-down list, do either of the following:

    ◦ Select the timeline/event plan to associate with the events being created by the wizard. If a timeline/ event plan chosen in the project does not have a country lead time for the reviewing country on the selected application, the lead times in the status schedule table are assumed to be zero. Projected dates are calculated using zero lead times and the project pivot status and status date. Click Next, and continue at step 10.

    ◦ Leave it blank if you do not want to use a timeline/event plan, and click Next as many times as is necessary to open the Associate Selected Products with Events page. Continue at step 12.

  10. Click Next after completing each Select Timeline/Event Plan page presented.After all the Select Timeline/ Event Plan pages are completed, a confirmation page tells you what actions will be taken.
  11. Choose the applicable procedure in the table below to enter an electronic signature in wizards:
    Scenario Steps
    When electronic signature is enabled
    1. In the confirmation page, select a reason and enter comments for the reason.
    2. Click Next.
    3. Validate your identity by entering your user credentials in the dialog box.
  1. Click Next.The Associate Selected Products with Events page opens.
  2. Do one of the following:

    ◦ If you selected one or more products in step 5 to associate with the applications, select either Yes or No to associate these products with the events that will be created by this wizard.

    ◦ If you did not select products in step 5 to associate with the applications, you must select No.

  3. Click Next.A confirmation page shows if the wizard will create your applications and the events for your applications.
  4. Choose the applicable procedure in the table below to enter an electornic signature in wizards:
    Scenario Steps
    When electronic signature is enabled
    1. On the confirmation page, select a reason and enter comments for the reason.
    2. Click Next.
    3. Validate your identity by entering your user credentials in the dialog box.
  1. Click Next.The Create Sequence(s) page opens.
  2. On the Create Sequence (s) page:

    ◦ To create a sequence, select Yes and click Next. The Sequence Attributes page opens. Go to step 18.

    ◦ To proceed without creating a sequence, select No and click Next. A message states that no input is required for sequences. Click Next to proceed to the Create Product Detail Sets page. Go to step 19..

  3. On the Sequence Attributes page, select or enter sequence attribute values.
  4. Click Next.A confirmation page shows that sequences will be associated with the events. For each application you created in the GPP wizard:

    ◦ The system creates an initial sequence with the attribute values you specified

    ◦ Each sequence is associated with the event in the project

    ◦ The system generates a Lifecycle order

  5. Click Next.The Create Product Detail Sets page opens. PDS templates must already exist in the system to create a PDS using the GPP wizard. One of the following occurs:

    ◦ If you have a PDM license with at least WRITE privileges to the PDS entity, you associated products with your applications in step 5, and you chose to associate products with events in step 12 , the wizard prompts you to create PDSs. Click Yes and proceed to step 20 or click No and proceed to step 27.

    ◦ If you do not have the PDM license with at least WRITE privileges to the PDS entity, or if you did not associate products with your applications in step 5, or if you chose not to associate products with events in step 12, proceed to step 27.

  6. Click Next.
  7. On the Select PDS Templates page, select a product from the Product drop-down list. The products listed are limited to those you selected for association with the applications earlier in the wizard.Any predefined PDS templates for the selected product are displayed in the Available list box.
  8. Select one or more templates. Note: Ennov best practice is to create only one PDS per product per application, and define different package sets within a PDS for the various presentations that go into packaging a product.
  9. Click Next.A confirmation page indicates whether the wizard will create a PDS for each template selected.
  10. to create the PDSs.The Select Another Product page opens.
  11. Do the following:

    ◦ If there were more products available for selection in step 22. , and you want to create PDSs from the PDS templates for another product, choose Yes and repeat step 20. through step 24. .

    ◦ If you have created all the PDS you want for the products available for selection in step 22. , choose No and proceed to step 27.

  12. Click Next.The Summary page confirms that the GPP wizard is complete.
  13. Do one of the following:

    ◦ Select the project link on the Summary page to review the new project you created.

    ◦ Click Finish to return to the view from which you invoked the GPP wizard.

  14. To view the project after closing the GPP wizard, click Home > Projects tab.
  15. Click the link for the project you just created to open the Project Attributes page. Note: If you created applications for the European Union of the Centralized Procedure (CP), WAHO (CP), Decentralized Procedure (DCP), or Mutual Recognition Procedure (MRP) procedure, you must manually modify the applications to include the Co-Rapporteur, Concerned Member States, and Arbitration Flag, when applicable.