Driving European

Medicines regulations on
Power Platform

Erwin Van Kouteren

Solution Architect, Capgemini, the Netherlands
European Medicines Agency
 European Medicines Agency (EMA)

“the scientific evaluation,

supervision, and safety monitoring of
medicines developed
by pharmaceutical companies for use
in the European Union (EU)”
IRIS Platform
Business Context
 Business context

Industry / Netwrok Notification /

Case Management Public Access
Controlled Access Reporting

Documents &
Receive
Reports
Submission by Industry Validate Data Consumption
Dashboards
Submission by NCA’s Assess
Communication
Publish
Financial
Management

Submission Portal CRM Power Platform IRIS Portal

 Key Interactions
Supply Chain

Developer / National
General
Marketing Competent
Public
Authorisation Holder Authority
HTA parties
& payers

EMA

Regulators Other EU Agencies

European
outside of the and international
Commission
EU partners
 Service
Technical landscape
management
Gatewa
y CESP EudaMed
CTIS eAF
CR EudraGMDP
Siamed ECD UPD EU-SRS
Submission Eudra PMS SMS ASU Case
management CTIS RMS EudraVig management
JIRA ART57
IAM
PSUR
SNOW MMD
DADI
EudraNet
EudraMail EudraLink
MMS
Productivity / collaboration
Technical landscape

IRIS Portal PLM Portal ESMP

Portal
Data
Analytics

Regulatory procedures / Case

management

Integration service layer

 Technology context

Productivity /
Documents / SharePoint
Office applications

Web Content
Submission
Customer Relationship Management
Gateway/
Management
EURS Enterprise
DW

Finance (ECD/OID) SPOR

Management Directory MDM
 Collaboration & data sharing Corrective Actions

Submission
Product
Regulated Products
Lifecycle
Management
Substance

Scientific Advice Research and Monitoring

Substance
Clinical Trial Development
Monitored Events
Real World Evidence

Service Delivery Service Delivery Service Delivery

Organisation, Contact
Experts
Agency Management
Fees Payments

Organisations, Contacts

Technology Lifecycle Management and

Identities, Access Service
Information Security Requests, Issues
 Increased collaboration
Improve business processes by providing a single data platform that links together all
customer related activities and integrates only once with data providers/consumers.

Customer-touching Portal for Portal for Portal for External users

applications Industry Network Stakeholders

Customer-facing Core CRM Internal users

applications Customer Business
Case mgt Analytics Knowledge
data rules
CRM platform
Why Power Platform

BPM CRM Case management Rule engine

Knowledge Reporting Channels Connectivity

management
Why Power Platform (2)
Microsoft Dynamics footprint with EU institutions and
agencies
 Financials

Source: Forrester, August 2022 - https://info.microsoft.com/ww-landing-forrester-tei-of-power-platform-premium-capabilities.html?LCID=EN-US

Security
 Security teams & roles

Identity providers and

authentication

User roles and authorization

Dataverse table permissions

Link between Identity Governance and Access Management

Review
Access User is
Termination Authorised to Adaptive
Approve
Access access EMA Access
Application

Multi Factor
Request Identity
Authentication
Access Governance User is active and
Access
approved to access
Management
EMA Application
Self
Service Risk
Registration Detection
Context Information: User Single
• Location Authentication Sign
• Behaviour MFA as norm On
• Device
• …
Power Platform @ EMA
 Data flow
Substance

Similar high level processes Product Case

across the value chain
Organisation
Receive
Individual

Validate
Document
Application
Assess
Activities link to the same data
Publish across the value chain.
 Microsoft Power Platform

Power Pages
Web App Development

Power Apps Power Virtual Agents

Application development Intelligent virtual agents

Dataverse
Business data platform

Power BI Power Automate

Business analytics Workflow automation
 Extending Power Platform replace
Dynamics 365 legacy
and Office 365 applications

Building departmental
Building mission-critical solutions
end-to-end solutions

AZURE

Data and Analytics

Key Topics & Lessons Learned
Innovation Creation & Responsibility
Built by any employee Built by superusers, CoE and/or partners
Apps, forms, simple databases, Environments, Common Data Service, Connectors, Apps
automated workflows templates, advanced workflows, AI…

Organisation Wide
Mission Critical initiatives

Number of Users
Complex processes Solutions
Simple Business and data Structure
Personal and
Solutions
Team
Productivity

Level of Complexity
Productivity Important Critical
Common business needs

Act on Insights Productivity Remote Notification/s Collaboration

in Data (CDH) Working
Driver of Change

Power Platform will accelerate digital transformation and allow you to conceptualise and build products
at a lighting pace.

Benefits of Power Platform

Attract, nurture and retain the best Automate and improve your processes Get new Insights from your data
talent

Dynamics 365 Innovation Apps Customer Operational Legacy Migration

standard Apps Engagement Apps Efficiency Apps Apps
Robust, Flexible & Scalable
Power Platform has the capability to implement innovation funnel in a safe and controlled manner.

Default
Production
• Environments
Development
Sandbox
• Environment types
Trial
• Controlling Power Platform:

• Scalability
 Financial

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

# of systems Speed of delivery

Source: Forrester, August 2022 - https://info.microsoft.com/ww-landing-forrester-tei-of-power-platform-premium-capabilities.html?LCID=EN-US
Power Platform Challenges
Getting started with the Microsoft Power Platform often aligns with the fear of the unknown, these are common
across most organisations but no challenge is insurmountable.

Understanding the business case for introducing the Power Platform

Uncertainty on how to start exploring the wider possibilities which can be unlocked using Power
Apps

Fear of proliferation of applications and “lack of control”

Setting up an effective innovation funnel for new ideas, how to manage demand, prioritise and
scale
Driving Adoption

A more specific targeted approach should be used to engage potential citizen developers to build on
Power Platform.

• Provide rewards & recognition

• Expand capabilities

• Target Citizen Developers

Adoption is Key

The success of Power Platform implementation is driven by those who experience the challenges first
hand. Capgemini can ensure high acceptance levels by helping you to build a lasting citizen developer
community.

CREATE A BUZZ START THE FOCUS DRIVE SENIOR

Provide non-technical COMPETITION ENGAGEMENT LEADERS’ BUY-IN
education of the Power
Create an interface for Run design thinking sessions Engage with senior
Platform and communicate people to submit problems to further drive interest and stakeholders in targeted
the benefits it can bring.
they would like to be solved. deepen knowledge. areas of the business.
 Low code maker experiences
• Power Pages Maker Studio
• Models driven apps / Canvas apps
• Templates hub
• Learn hub
Low code • Data modeling and visualization
website / app maker
Pro-dev experiences
• In-line code editor
fusion teams • VS Code extensions
• Github and Azure DevOps integration for
ALM

IT admin / DevOps experiences

• ID providers and authentication
Administrator / Pro developer • User roles and authorization
DevOps • Table permissions
Future & Conclusions
 ESubmisions - Vision for the Online Presence

Medicines Portals Corporate Website Intranet Portals for regulatory Portals for Portals for service
scientific activities stakeholder management
engagement
Audience Patients/citizens General public and EMA workforce Medicine and medical Partners, academia, Extended workforce,
and human/animal key influencers device industry, NCAs delegates customers, partners
health (industry, EU and
professionals international
regulators)
Content Information on Information on the Information on Access point for Access point for (long- Access point to
human (European European regulatory organisations and regulatory scientific term) non-regulatory resolve users’ (short-
Medicines Web system, EMA, news working practices; applications and activities term) requests
Portal) and knowledge base notifications
veterinary
medicines (Union
Product DB)
Transformation takes time
Why use the Power Platform?

The business case to invest in the Power Platform is proven

by cross-industry metrics and market trends.
Recognises Microsoft as a Leader for the
thirteenth consecutive year in the Gartner 2020
Magic Quadrant for Analytics and Business.

Pace of Innovation

Reducing cost “Creating in Power Apps helped the team steer

clear of hurdles that could occur when developing
without professional developers. The apps saved
the organization about $500,000 in just the first
year.”

Customer Experience
.

The Most Disruptive Trend of 2021: No Code /

Low Code.
“If you want to go far, go together”

Data ecosystems enable value creation that EMA/NCAs could not do alone
Questions / Continue the dialogue

https://www.linkedin.com/in/erwin-van-
kouteren-600ab71/

@evankouteren