How the Conforma Demo Works

This demo system allows you to have a personal login with pre-set characters and applications already loaded to help you get a feel for the flexibility of Conforma.

Levels of Regulator

There are different ‘levels’ of regulator in the demo, which represent the types of workflows different countries may have, dependent on their regulatory maturity and capacity. Not every country needs to have a full common technical document (CTD) product registration workflow!

The Established Regulatory Authority includes more complex workflows, including:

• Company Licencing
• Import Permits for Medicines
• Market Authorisation (full registration)
• Adverse Drug Reaction (ADR) Reports

The Emerging Regulatory Office has fewer and less complex workflows, limited to:

• Provisional Listing (uses products already registered internationally as a basis, so requires limited technical evaluation)
• ADR Reports.

External users in the demo

You can log in with the username Grace (and the password you used to register for the demo). Grace is a fictional consultant who works for two different companies (you can switch between them in the Menu bar, or select at login):

• Novara - a company who is engaging with the Established Regulatory Authority to register medicines
• Pharma Distributors - A local importer who is listing their medicines with the Emerging Regulatory Office.

By switching between the two companies, you can test the different workflows from each regulator level.

Alternatively you can also register yourself as a new user by selecting Create New Account on the login page and work your way through the process from scratch (such as registering a company, acquiring a license, registering a product, etc.)

Internal users in the demo

There are four internal user characters you can login as. Three of these characters work for the Established Regulatory Authority, and one works for the Emerging Regulatory Office.

Established Regulatory Authority

Rajiv - Screener and Technical Evaluator Use this account to:

• Review company licence applications
• Review import permits for medicines
• Review Adverse Drug Reaction (ADR) reports
• Perform initial screening and of Market Authorisation (product registration) applications

Jane - Assessor and Senior Evaluator (e.g. Consolidator) Use this account to do the same as Rajiv, except:

• Do Assessment (second stage) of Market Authorisation applications, as well as final consolidation (approve the existing review)

Fatima - Director Can do the final Approval of Market Authorisation applications.

Emerging Regulatory Office

Cyrus - Staff member who can review and approve all applications

Guidance on how to navigate the demo

See the Guidance sections for step-by-step walk-throughs on different activities and processes that you can familiarise yourself with in the Conforma Demo.

If you have any questions at all on the demo or on a specific process, please reach out to us at support@conforma.nz.