PharmaLedger – First Report of Engagement of Regulatory and Standardization Strategy

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives
support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Copyright © PharmaLedger Consortium 2020 – 2023 PharmaLedger: www.pharmaledger.eu IMI: www.imi.europa.eu
D6.8 First Report of Engagement of Regulatory and
Standardization Strategy
Deliverable No D6.8
Work package No. and Title WP6 Culture and Adoption
Version - Status V1.0 – final - Reviewed
Date of Issue 30/12/2020 (review date 12/05/2020)
Dissemination Level PUBLIC
Filename D6.8 First Report of Engagement of Regulatory and Standardization
Strategy_v1.1_final
Ref. Ares(2021)3174852 - 12/05/2021

PharmaLedger – 853992 | Deliverable D6.8 v1.1 | PUBLIC 2/31
DOCUMENT INFO
Authors
Author Organization
Daphné VAN dER EYCKEN KU Leuven (KUL)
Henrik Kim NIELSEN Novo Nordisk (NOVO)
Thomas RASMUSSEN Novo Nordisk (NOVO)
Nenad GEORGIEV KU Leuven (KUL)
Document History
Date Version Editor Change Status
09.10.2020 0.1 Daphné Van der Eycken Template Draft
15.10.2020 0.2 Daphné Van der Eycken Table of contents Draft
16.10.2020 0.3 Daphné Van der Eycken Initial content Draft
09.11.2020 0.4 Daphné Van der Eycken Continuous input in sections Draft
09.12.2020 0.5 Daphné Van der Eycken Complete draft for review Draft
09.12.2020 0.6 Henrik Kim Nielsen Internal review Draft
11.12.2020 0.7 Nenad Georgiev Internal review Draft
17.12.2020 0.8 Elisabetta Biasin Internal review Draft
24.12.2020 0.9 Anton Vedder Internal review Draft
30.12.2020 0.10 Tamanna Khan Quality review Draft
30.12.2020 1.0 Daphné Van der Eycken Final adaptations Final
12/05/2021 1.1 María Eugenia Beltrán/
Cecilia Vera
Formatting and disclaimer
added as requested by IMI/EC
Final
Disclaimer: Any information on this deliverable solely reflects the author’s view and neither IMI nor the European
Union or EFPIA are responsible for any use that may be made of the information contained herein.

TABLE OF CONTENTS
TABLE OF CONTENTS.....................................................................................................................................3
LIST OF TABLES..............................................................................................................................................5
LIST OF FIGURES............................................................................................................................................5
ACRONYMS ...................................................................................................................................................6
EXECUTIVE SUMMARY..................................................................................................................................8
1. Introduction ..........................................................................................................................................9
2. Pharmaledger regulatory and standardization engagement goals ......................................................9
3. Use cases output.................................................................................................................................10
3.1 DRA1 Supply chain......................................................................................................................10
3.2 DRA2 Health data........................................................................................................................11
3.3 DRA3 Clinical trials ......................................................................................................................12
4. Stakeholder mapping..........................................................................................................................13
4.1 Regulators...................................................................................................................................13
4.2 Standardization bodies ...............................................................................................................13
4.3 Patients .......................................................................................................................................13
4.4 Industry stakeholders .................................................................................................................14
4.5 Organizations working with blockchain technology...................................................................14
4.6 Other stakeholders including research centres..........................................................................14
5. PharmaLedger regulatory and standardization engagement strategy...............................................14
5.1 Inform .........................................................................................................................................15
5.2 Consult ........................................................................................................................................15
5.3 Interact........................................................................................................................................15
5.4 Collaborate..................................................................................................................................15
6. Past Stakeholder Engagement Activities ............................................................................................16
6.1 EC DG Connect ............................................................................................................................16
6.2 EMA.............................................................................................................................................17
6.3 BC Observatory ...........................................................................................................................18
6.4 GLEIF ...........................................................................................................................................19
6.5 GS1..............................................................................................................................................20
6.5.1 Identity Topic ......................................................................................................................20
6.5.2 EPCIS Topic..........................................................................................................................21
6.6 EMVO ..........................................................................................................................................22
7. Next planned activities .......................................................................................................................23
7.1 EMA Innovation Task Force ........................................................................................................23
7.2 Reach out to DKMA/HMA...........................................................................................................23

7.3 Present to ICH E6 (GCP) EWG .....................................................................................................23
7.4 Position papers from patient organizations ...............................................................................23
7.5 Form an HL7 working group........................................................................................................23
7.6 Other stakeholders .....................................................................................................................23
7.7 Monthly meetings.......................................................................................................................23
8. Conclusion...........................................................................................................................................24
Annex I Overview of main stakeholder groups from the Grant Agreement and prioritization based on use
cases............................................................................................................................................................25
Annex II Overview of the other stakeholder groups and prioritization based on use cases......................28

LIST OF TABLES
Table 1 Information on interaction with EC Connect .................................................................................16
Table 2 Information on interaction with EMA............................................................................................17
Table 3 Information on interaction with BC Observatory ..........................................................................18
Table 4 Information on interaction with GLEIF...........................................................................................19
Table 5 Information on interaction with GS1 - Identity..............................................................................20
Table 6 Information on interaction with GS1 - EPCIS .................................................................................21
Table 7 Information on interaction with EMVO .........................................................................................22
LIST OF FIGURES
Figure 1 Four-layered level of engagement................................................................................................14
Figure 2 EC Connect Blockchain for Healthcare..........................................................................................16
Figure 3 European Medicines Agency logo.................................................................................................17
Figure 4 BC Observatory Convention on Blockchain applications in Healthcare .......................................18
Figure 5 Global Legal Entity Identifier Foundation (GLEIF) logo.................................................................19
Figure 6 GS1 logo ........................................................................................................................................20
Figure 7 European Medicines Verification Organisation logo ....................................................................22

ACRONYMS
ABPI Association for British Pharmaceutical Industries
AME Affordable Medicines Europe
Anti-cft Anti-counterfeiting (use case)
BC Observatory European Blockchain Observatory and Forum
CS trace Clinical Supply Traceability (use case)
CT recruit Clinical Trial Recruitment (use case)
DKMA Danish Medicines Agency
EC European Commission
eConsent Electronic Consent (use case)
EFPIA European Federation of Pharmaceutical Industries and Associations
eLeaflet Electronic Leaflet (use case)
EMA European Medicines Agency
EMVO European Medicines Verification Organization
EPF European Patient Forum
EU Unit F.3 European Union Digital Innovation and Blockchain (Unit F.3)
EU-PMHP European Union People with Mental Health Problems
FDA Federal Drugs Agency (USA)
FG trace Finished Goods Traceability (use case)
GHM Greek Health Ministry
GIRP European Healthcare Distribution Association
GMA Greek Medicines Agency
GS1 Global Standards 1
HAPC Hellenic Association of Pharmaceutical Companies
HL7 Health Level 7 International
HMA Heads of Medicines Agencies
HOPE European Hospital and Healthcare Federation

HTAC Health Technology Assessment Committee (Greece)
ICH International Council for Harmonization
ICH E6 EWG International Council for Harmonization E6 Expert Working Group
ICH-GCP International Council for Harmonization Good Clinical Practice
ICO Information Commissioner’s Office
IEEE-SA Institute of Electrical and Electronics Engineers Standards Association
IMI Innovative Medicines Initiative
ISO International Organization for Standardization
MD IoT Medical Device Internet of Things (use case)
MfE Medicines for Europe
MHMD MyHealthMyData
MHRA Medicines and Healthcare products Regulatory Agency
NAHS National Agency for Health Services (Greece)
NPHO National Public Health Organization (Greece)
PAPI Panhellenic Association of Pharmaceutical Industries
Pers. Med Personalised Medicine (use case)
PGEU Pharmaceutical Group of European Union
PhUSE Pharmaceutical Users Software Exchange
SLA Scottish Lifesciences Association
SPMS Serviços Partilhados do Ministério da Saúde

EXECUTIVE SUMMARY
The D6.8 PharmaLedger First Report of Engagement of Regulatory and Standardization Strategy
deliverable establishes and documents a plan for the regulatory and standardization approach and
strategy for the PharmaLedger project.
Through this deliverable, the PharmaLedger project seeks to understand its stakeholders’ opinions and
concerns, and to involve them early in the project buildout. Therefore, this report describes the purpose
for engagement with stakeholders, exemplifies its goals and output through its different use cases,
stresses the importance of sound coordination between the use cases as well as the value of combining
or consolidating various interactions, and defines priority areas for a sound and strategic engagement
approach. It identifies which stakeholders are relevant and indicates their importance to the project. It
reports on how the project has engaged with relevant stakeholders up until now and lists the upcoming
activities. Finally, this document outlines the timeframe that is required to achieve the set ambitions.

1. Introduction
PharmaLedger has the ambition to provide a widely trusted platform that supports the design and
adoption of blockchain-enabled healthcare solutions. To be successful, PharmaLedger will need to build
trust, which in turn demands investment in strong stakeholder engagement and open communication.
This document has eight main sections. Section 1. Introduction provides readers with a map of the overall
report to let the reader understand what the deliverable is about. Section 2. PharmaLedger regulatory
and standardization engagement goals aims to outline the motivation behind the drafting of this report
and inform the readers of which goals are pursued when interacting with stakeholders. Section 3. Use
cases output aims to illustrate the output of the PharmaLedger project through its different use cases as
well as describing the importance of stakeholder engagement for each specific use case. Section 4.
Stakeholder mapping creates an overview of all relevant stakeholders and categorizes them in sub-groups
according to their respective interests and potential input. Section 5. PharmaLedger regulatory and
standardization engagement strategy provides the four-layered approach of engagement that will be
adopted by the project to ensure effective and coordinated interactions with stakeholders. Section 6. Past
stakeholder engagement activities provides an overview of the engagement activities already conducted
by PharmaLedger and Section 7. Next planned activities provides an overview of the upcoming
engagement interactions. Section 8. Conclusion synthesizes the deliverable. Finally, Annex I Overview of
main stakeholder groups from the Grant Agreement and prioritization based on use cases, and Annex II
Overview of the other stakeholder groups and prioritization based on use cases place all identified relevant
stakeholders on the map according to the category to which they belong, their importance for the
PharmaLedger project, their potential input and the priority they enjoy within the project’s regulatory and
standardization engagement strategy.
This report aims to serve as the background for WP6.4 to initiate and maintain valuable interactions with
stakeholders. It seeks to understand their opinions and concerns so as to involve them early in the
project’s buildout.
By embracing and encouraging engagement of the relevant stakeholders, PharmaLedger intends to gain
their trust and support. PharmaLedger wants to positively influence discussions on standardization,
regulatory, legal and data privacy topics, thus making change at the right place in order to be legally
considered in many countries and enhancing the overall effectiveness and impact of the project.
2. Pharmaledger regulatory and standardization engagement goals
The integration of digital technologies within the healthcare sector promises to make healthcare safer,
better, more personalized and overall, more efficient.1
However, these new tools are developed at a faster
rate than they can be assessed for safety and effectivity. They thereby give rise to many questions for
policymakers and stakeholders. If the creators behind these newly emerging tools do not pay attention to
these concerns, they risk compromising the viability and long-term benefits of digital health.
To give an answer to policymakers’ and stakeholders’ questions and concerns, it is necessary to engage,
share knowledge and collaborate with them. This in turn requires a solid engagement strategy. If well
thought-out, an engagement strategy allows to raise attention to the project’s work and allows
stakeholders to provide valuable feedback and improve the project’s work. It extends awareness on the
potential of blockchain technology within healthcare, promotes public confidence in digital health and
helps shape regulation as well as positively influence standardization wording to unlock the potential of
blockchains.
1
Hermes, S., Riasanow, T., Clemons, E.K. et al. The digital transformation of the healthcare industry: exploring the
rise of emerging platform ecosystems and their influence on the role of patients. Bus Res (2020).
https://doi.org/10.1007/s40685-020-00125-x.

More specifically tailored to this project’s needs and following the actions from the Grant Agreement,
PharmaLedger will pursue the following goals:
1. Engage with the International Council for Harmonization Good Clinical Practice (‘ICH-GCP’)
working group, for advice on how good clinical practice principles are maintained and
implemented.
2. Plan and execute a meeting with the European Medicines Agency (‘EMA’), with participation
from the Pharmaceutical Users Software Exchange (‘PhUSE’) and the Institute of Electrical and
Electronics Engineers Standards Associatio (‘IEEE-SA’) where appropriate.
3. Engage with Health Level 7 International (‘HL7’) for health care data management and
integration.
4. Propose an alliance formation of EU PharmaLedger medical device manufacturers, healthcare
delivery organizations, and potential patients (such as the European Union – People with Mental
Health Problems (‘EU-PMHP’) organization).
5. Engage with the relevant blockchain standardization bodies to introduce standard extensions or
complementary standards, such as MyHealthMyData (‘MHMD’), the PhUSE blockchain project,
EU Blockchain Observatory and Forum (‘BC Observatory’) and the International Organization for
Standardization (‘ISO’) Technical Committee 307/SG (Blockchain use cases) and contribute to
standards to ensure interoperability with PharmaLedger Blockchain.
6. Engage with standardization bodies and trading alliances such as Global Standards 1 (‘GS1’),
IEEE, ISO, European Medicines Verification Organization (‘EMVO’), European Federation of
Pharmaceutical Industries and Associations (‘EFPIA’), European Healthcare Distribution
Association (‘GIRP’), Medicines for Europe (‘MfE’), Pharmaceutical Group of European Union
(‘PGEU’), and European Hospital and Healthcare Federation (‘HOPE’).
7. Organize an “innovation day” for EMA and others. Invite entities such as IEEE, PhUSE, etc. to
demonstrate blockchain solution
8. Form an advisory board consisting of members from different stakeholders.
3. Use cases output
The three tables below aim to illustrate the output of the PharmaLedger project through its different use
cases in accordance to the Domain Reference Area (‘DRA’) they belong to, as well as describing the
importance of stakeholder engagement for each specific use case.
3.1 DRA1 Supply chain
Use Case Short description and importance of regulatory engagement
Supply
Chain
eLeaflet Short description
This use case starts with the creation of the ePI in digital form by the
manufacturer, the review and approval of the ePI with the health
authorities, updates to the ePI and dissemination of the ePI to the Patient/
Health Care Practitioner/ Provider (HCP).
Importance of regulatory engagement
Collaborate with regulatory authorities for evaluation of the digital key and
blockchain solution adoption; collaborate with stakeholders on proof of
concept for a single EU-healthcare app for eLeaflet access.
Short description

Anti-
Counterfeiting
('Anti-cft’)
This use case has the intention to build upon the existing European
Medicines Verification Organization (EMVO) solution for serialization to
further strengthen the integrity of the supply chain, ideally by enabling a
two-factor authentication of the product, serial number and anti-
counterfeit feature.
Evaluate with standardization bodies to evaluate benefits of blockchain for
immutability, security and interoperability; engage with regulatory
authorities on interoperability pilots and policies; evaluate what key
resources, specific expertise and collaborations are required; engage with
EMVO on their roadmap to improve EMVS technical foundation, potentially
adding immutability and interoperability.
Finished Goods
Traceability
(‘FG trace’)
Short description
This use case looks at methods of data capture and transfer, on/off chain
storage in a mobile and integrative flexible architecture which will allow for
a trusted downstream supply chain visibility with near real-time data
availability.
Exchange on epics, user stories and requirement specifications; collaborate
with distributors and pharmacies.
Clinical Supply
Traceability
(‘CS trace’)
Short description
This use case provides traceability of finished goods over the blockchain by
defining a protocol adapted for the blockchain connecting supply chain
partners, accelerating information sharing and facilitating incorporation of
new partners into the system, including patients.
Exchange on epics, user stories and requirement specifications; collaborate
with distributors and pharmacies, engage with other sponsor’s SMEs; buy-
in and engagement from external partners; exchange data standards
expertise; exchange data privacy legal expertise.
3.2 DRA2 Health data
Health
data
Clinical Trial
Recruitment
(‘CT recruit’)
Short description
This use case creates a cross-industry solution to pre-screen patients for
clinical trials, leverages blockchain as a shared ledger of patient permissions
accessible by multiple parties without any single party in charge and

implements dynamic permissioning to create a patient-centric solution for
the entire industry that streamlines clinical trial recruitment.
Engage with other sponsors’ SMEs; sample pre-screening criteria from
sponsors; exchange data privacy legal expertise.
Personalized
Medicine
(‘Pers. Med.')
Short description
This use case creates a trusted environment supporting patient-centric
solutions for value-based health delivery in clinical practice and generation
of real-world evidence for research purposes in order to apply it to improve
diagnosis, prevention and personalized treatment.
Exchange data privacy legal expertise; HPC intervention; data sources;
ePermission Enabler; IoT enabler; artificial intelligence, machine learning
rules and data models.
3.3 DRA3 Clinical trials
Clinical
trials
eConsent Short description
This use case leverages blockchain to develop a platform which can be used
by all sponsors, regulators, ethics committees and sites labs, offering the
ability to improve compliance and traceability, automate procedures,
increase efficiency, and provide real-time visibility of consent and
enrolment status to the relevant stakeholders while maintaining privacy.
Engage with regulators and ethics committees for support; exchange on
data privacy legal expertise; exchange on decentralization of IDs; consult
with patient group to develop user-friendly interface.
IoT Medical
Devices in
Clinical Trials
(‘MD IoT’)
Short description
This use case provides dynamic acquisition, processing of data from
consumer and medical devices to accelerate clinical development.
Engage with patients’ organizations and principal investigators; sample pre-
screening criteria from sponsors; exchange data privacy legal expertise;
exchange on off-chain, APIs and data models for interoperability; exchange
on data analytics.

4. Stakeholder mapping
The outputs of PharmaLedger target a wide range of stakeholders in different ways and for a variety of
different purposes. To enable the understanding and engagement of PharmaLedger’s stakeholders, it is
therefore necessary to create an overview of all relevant stakeholders. Given the broad reach of this
project, stakeholders should also be categorized and sub-divided into the following groups:
- Policymakers/regulators,
- Standardization bodies,
- Patients,
- Industry,
- Organizations working with blockchain technology,
- Other stakeholders, including research centres.
More information on these different groups are given below.
4.1 Regulators
National and European policy decision-makers and regulators directly impact the deployment and success
of the PharmaLedger solution by supporting the project in navigating through the regulatory landscape
and other barriers. The EMA is the primary target and enjoys absolute priority in PharmaLedger’s
regulatory engagement strategy. Other regulatory agencies and bodies in charge of the evaluation and
supervision of medicines outside of EU's jurisdiction, such as the United States Federal Drugs Agency
(‘FDA’), are also important targets for engagement. Actions to reach out to these regulators, however,
shall not be initiated before gaining experience from interactions with the EMA. Regulatory interactions
typically involve:
- requesting a meeting often including questions/discussion items,
- submitting a briefing document, and
- organising meetings (including making the presentation and drafting the minutes).
The ICH develops guidelines for medicines development in Expert Working Groups (EWG) consisting of
both regulators and industry representatives. The ICH E6 EWG is updating the Good Clinical Practice
guideline and PharmaLedger will be reaching out to the EWG.
4.2 Standardization bodies
Standardization bodies can influence standardization work across industries. The engagement of
PharmaLedger in standardization processes is an essential part of the architectural development of the
PharmaLedger platform as existing standards would have to be properly implemented to support the
interoperability of the platform.
HL7, as a widely adopted standards framework for the exchange, integration, sharing, and retrieval of
electronic health information is PharmaLedger’s primary target. An HL7 representative is part of the
project’s External Ethics Advisory Board (‘EEAB’). Other targets for PharmaLedger project include GS1, ISO
and IEEE. Any other associations defining and developing relevant standards are also part of this group.
4.3 Patients
The involvement of patients and patient organizations should be encouraged with the greatest possible
attention since participation of patients in health care has been associated with improved treatment
outcomes.2
PharmaLedger will engage this stakeholder group and continuously inform them of the
2
Bombard, Y., Baker, G.R., Orlando, E. et al. Engaging patients to improve quality of care: a systematic
review. Implementation Sci 13, 98 (2018). https://doi.org/10.1186/s13012-018-0784-z.

advancements of the project. By being part of the Consortium, EU-PMHP and the European Patients’
Forum (‘EPF’) enable patients’ involvement in the outcome of the PharmaLedger project.
4.4 Industry stakeholders
Industry associations such as EFPIA, HOPE, EMVO and MfE play a role around the benefits and business
opportunities of PharmaLedger amongst their members. They are also important in contributing to
stakeholder engagement activities and in facilitating participation in standardization bodies.
4.5 Organizations working with blockchain technology
PharmaLedger wants to explore opportunities to partner with other organizations involved in blockchain
technology such as the BC Observatory, the Horizon 2020 project MHMD and the US project PhUSE.
4.6 Other stakeholders including research centres
Research centres are particularly crucial for gaining insights, share knowledge and learning.
5. PharmaLedger regulatory and standardization engagement strategy
To inspire the confidence of its stakeholders, it is of paramount importance that PharmaLedger builds
effective relationships with them. An effective regulatory engagement strategy requires focusing on
ensuring that all engagements with stakeholders are managed in a logical, transparent, and well-
coordinated manner by defining how regulatory relationships and communications are to be handled at
project level. This creates standardized practices, processes, and tools, which can help build successful
relationships with regulators.
It is important to note that PharmaLedger aims to exemplify its goals through eight different use cases.
Because policymakers and regulators have limited time and resources, it will not be possible to induce a
separate interaction for each of the eight use cases. To optimize the time and effort spent on regulatory
meetings, PharmaLedger will have to standardize the process as much as possible—right from the meeting
preparation stage, to the actual interaction and subsequent follow-ups. The project will thus have to
invest in effective coordination to link the different use cases with their specific needs if it does not want
to miss out on crucial opportunities. It is the project’s ambition to build a strategic approach to
interactions and, where possible, combine or consolidate various interactions. Annex I and II aim to
document all these different needs. Whenever more than one use case has expressed interest to interact
with a certain stakeholder, the WP6.4 leads will make sure to coordinate these interactions to facilitate
smooth and effective communication. When dealing with the European Commission (‘EC’), all
communication will go through the project coordinator.
Depending on the goals, PharmaLedger proposes a flexible range of approaches. For this reason,
PharmaLedger puts forward a four-layered level of engagement:
Inform Consult Interact Collaborate
Figure 1 Four-layered level of engagement

5.1 Inform
PharmaLedger will provide accurate and consistent information to inform regulators about
PharmaLedger’s work. It is the project’s intention to build a greater understanding of its role in the
development of digital health and build public trust by seeking to be an exemplar of transparency through
the engagement with regulators and publication of clear information.
The way to go about this first layer of engagement will be through:
- Correspondence,
- Regular feedback,
- Website,
- Social Media,
- Newsletters,
- Conferences, and
- Easily accessible videos.
5.2 Consult
PharmaLedger will welcome and actively seek feedback from external regulatory and standardization
bodies. The project will include them in an early stage to be as inclusive as possible and invite their
views where the project’s use cases need input to proceed.
- Contacting relevant regulatory and standardization bodies,
- Invest in continuity with successful contacts,
- Gather stakeholder feedback enabling PharmaLedger to learn, improve, and adapt the technical
solutions to evolving stakeholder needs.
5.3 Interact
New regulation can put value at risk. It can increase costs of operation, introduce legal and administrative
hurdles, lead to negative reputation in case of non-compliance and even put an end to a project. However,
new regulatory activity can also unlock new opportunities when it encourages investment, increases legal
certainty, tailors applicable rules to specific situations and standardizes complicated procedures. Through
successful interactions with regulators, it is possible to positively influence the outcome of said activities,
tailor the result to the PharmaLedger objectives and create new opportunities. Therefore, a rigorous,
quantified assessment of the value at stake from these risks and opportunities—over both the long and
short term—is critical when planning PharmaLedger’s outreach efforts.
- Workshops,
- Expert committees, and
- Comment on draft guidelines or standards.
5.4 Collaborate
PharmaLedger will work collaboratively and strategically with regulators, both at the EU and US level, to
facilitate the sharing of findings and support the drive towards a more efficient digital health.
The way to go about this first layer of engagement will be through roundtables with expert panels and
decision-makers.

6. Past Stakeholder Engagement Activities
The following provides an overview of the engagement activities already conducted by PharmaLedger.
6.1 EC DG Connect
Figure 2 EC Connect Blockchain for Healthcare
When 29 September 2020 Where Online Venue link
Theme Digital health, blockchain, exchange of electronic medical information
Details Session to talk about the way blockchains could transform healthcare, enabling key
stakeholders such as doctors, pharmacists, clinical researchers to gain secure and
faster access to electronic medical information.
Organizers CONNECT University
Who Nenad Georgiev, KUL
What Mention and short introduction of the PharmaLedger project by DG CONNECT
Dissemination Public
Event material Website
Table 1 Information on interaction with EC Connect

6.2 EMA
Figure 3 European Medicines Agency logo
Theme Digital health, processing of personal data, GDPR
Details Half-day workshop with medicines developers and EMA’s network of research-
performing, research-supporting academic infrastructures and data providers, that
gives participants an overview of the European Commission’s work on the creation
of the European Health Data Space, followed by a discussion on the development of
an EU-wide governance framework and a future code of conduct on the processing
of personal data in the health sector. Additionally, the application of the GDPR in the
health sector and the secondary use of health data for medicines and public health
purposes have been addressed at the meeting.
Organizers EMA
Who Nenad Georgiev, KUL
What Interaction to understand EMA’s position on secondary use of health data
Dissemination Closed to invited stakeholders.
Event material Website; Documents
Table 2 Information on interaction with EMA

6.3 BC Observatory
Figure 4 BC Observatory Convention on Blockchain applications in Healthcare
Theme Blockchain, digital health, data exchange, dynamic consent
Details Workshop about blockchain applications in healthcare. Experienced speakers shed
light on the application of blockchain in the sector and discuss the obstacles that have
occurred throughout their implementation.
Organizers European Blockchain Observatory and Forum (‘BC Observatory’)
Who Konstantinos Votis (CERTH), Sînică Alboaie (RMS), Marco Cuomo (NVS)
What Presentation of PharmaLedger
Dissemination Public
Event material Website
Table 3 Information on interaction with BC Observatory

6.4 GLEIF
Figure 5 Global Legal Entity Identifier Foundation (GLEIF) logo
When 16 November 2020
and 1 December 2020
Where Online Venue Novartis MS
Teams
Theme PharmaLedger introduction, potential collaboration with GLEIF
Details Specific focus on Identity Management PoC/Pilot
Organizers Daniel Fritz, PharmaLedger Industry Lead
Who Damir Bucar, Malschok Sneha, Daniel Fritz, Marco Cuomo, Carsten Stoecker,
Hrishikesh Nashikkar, Karla Mckenna, Christoph Schneider, Christos Patsonakis,
Sînică Salboaie, Xenia Beltran, Stephan Wolf
What Agreed to evaluate participation in PharmaLedger’s identity management task force
in 2021
Dissemination Summary of meeting
Event material Summary of meeting, standard PharmaLedger introduction presentation, Identity
Management Task Force Overview
Table 4 Information on interaction with GLEIF

6.5 GS1
Figure 6 GS1 logo
6.5.1 Identity Topic
When 8 November 2020 and
1 December 2020
Where Online Venue Novartis MS
Teams
Theme PharmaLedger Introduction, potential collaboration with GS1
Details Specific focus on Identity Management PoC/Pilot
Who Gena Morgan, Carsten Stoeker, Hrishikesh Nashikkar, Marco Cuomo, Damir Bucar,
Robert Beideman, Michael Ruether, Georg Juergens, Christos Patsonakis, Sînică
Salboaie, Xenia Beltran
What Agreed to evaluate participation in PharmaLedger’s identity management task force
in 2021
Event material Standard PharmaLedger introduction presentation, Identity Management Task Force
Overview
Table 5 Information on interaction with GS1 - Identity

6.5.2 EPCIS Topic
When 3 December 2020 Where Online Venue Novartis MS
Teams
Theme PharmaLedger Introduction, potential collaboration with GS1 for Material
Traceability Use case
Details Specific focus on application of GS1 EPCIS Standard v2.0
Who Daniel Fritz, Amit D. Deshpande, Craig Alan Repec, Jan Wortmann
What Agreed to review new EPCIS standard and reconvene in January, 2021 to review its
application to the use case
Event material Standard PharmaLedger introduction presentation, Material Traceability use case
presentation
Table 6 Information on interaction with GS1 - EPCIS

6.6 EMVO
Figure 7 European Medicines Verification Organisation logo
When 17 December 2020 Where Online (MS Teams
hosted in
Brussels)
Venue EMVO
Conference
Room
Theme PharmaLedger introduction, potential collaboration
Details Specific focus on Anti-CF use case.
Organizers EMVO management
Who EMVO stakeholder representatives, EMVO admins, EMVO management, Fanny
Trenteseaux, Mark Scott, Stephan Theunissen, Andreas Walter, Martin Fitzgerald,
Adrian van den Hoven (MfE), François Bouvy (EFPIA), Monika Derecque-Pois, Kasper
Ernest, Stephanie Kohl, Pascal Garel, Daniel Fritz (NVS), Ilaria Passarani.
What Discussion on EMVO’s response to PharmaLedger in January 2021 for next steps to
take.
Dissemination Waiting for minutes.
Event material Standard PharmaLedger introduction presentation
Table 7 Information on interaction with EMVO

7. Next planned activities
It will be vital to monitor and evaluate our stakeholder engagement activity on a regular basis. Evaluation
allows assessing interactions and their impact. It will be based on providing updates on engagement
activity through the organization of monthly meetings specially dedicated to keeping all partners updated.
The following actions are intended to support a more coordinated and effective approach to stakeholder
engagement.
7.1 EMA Innovation Task Force
Interaction through the EMA Innovation Task Force is planned on 27 January 2021 together with the sister
IMI project GravitateHealth with a focus on e-labelling.3
The Innovation Task Force meeting will be
prepared, and various internal meetings will be set up to organize and make meeting document and
presentation/HMA.
7.2 Reach out to DKMA/HMA
The project has reached out to the DKMA representative in the HMA/EMA joint Big Data Steering Group
to initiate and interact with this group.
7.3 Present to ICH E6 (GCP) EWG
The project will meet with the European industry representatives in the ICH E6 EWG who are from
PharmLedger member companies Novartis and Novo Nordisk.
7.4 Position papers from patient organizations
PharmaLedger will look out for an invitation to contribute in position papers from patient organizations.
By doing this, PharmaLedger hopes to shed on its activities and be involved in digital health debates.
7.5 Form an HL7 working group
The project wants to have a new home to build new standards. PharmaLedger aims to achieve this through
interaction with HL7, which has already been approached by the IoT Use Case. Moreover, the HL7 is
represented in the EEAB. To further facilitate and coordinate interactions with HL7, a working group will
be set up.
7.6 Other stakeholders
In the beginning of 2021, interactions with the remaining stakeholders listed in the Grant Agreement will
be developed through the adoption of a definite timeframe.
7.7 Monthly meetings
WP6.4 has set up monthly meetings meant to share updates between partners and contribute to effective
implementation of the regulatory and standardization engagement strategy.
3
More information on the GravitateHealth project can be found on the IMI website
https://www.imi.europa.eu/projects-results/project-factsheets/gravitate-health.

8. Conclusion
A robust and effective engagement with regulators will be crucial to the success of the PharmaLedger
project as a whole. The objective of this deliverable is to involve stakeholders in the evolution of the
PharmaLedger technical solution and contribute to its future success.
To achieve this goal, this document has identified the precise engagement goals, outlined use cases
output, mapped stakeholders, and set out a clear strategic plan to go about these interactions. Finally,
this deliverable reported on the past stakeholder engagement activities and next planned activities to
monitor the effective implementation of the developed strategy.

Annex I Overview of main stakeholder groups from the Grant Agreement and prioritization based on use
cases
This Annex provides an overview of the PharmaLedger’s stakeholders that are identified within the Grant Agreement. These stakeholders were identified as
critical for PharmaLedger’s regulatory and standardization strategy. The Annex below identifies the stakeholders that should be prioritized for proactive
engagement based on the project’s use cases’ needs. This overview must be considered as a working document as it may be updated and/or extended as the
project matures, and the relative priority of engagement for each stakeholder will be assessed on an ongoing basis.
Stakeholder Category Impact Importance Contribution
Engagement
approach
Relevant
use cases
Priority
level
Proposed
timeframe
BC
Observatory
Research centre Medium
To keep informed of the blockchain
activities of PharmaLedger. To
leverage their standards expertise
and to potentially use IEEE as a way
for PharmaLedger to formalize
standards
Providing visibility into
PharmaLedger and
supporting adoption
Internal
Meeting/
Report to the
Head of the
Organization
None in
particular
Medium TBD
EFPIA Industry Medium
To keep informed of the project
status and the ways it impacts
pharma companies
Support for adoption,
high-level contacts, and
industry credibility
Internal
Meeting/
Report to the
Head of the
Organization
e-PI Medium TBD
EMA
Policymaker/
Regulator
High
Pre-alignment and endorsement of
PharmaLedger proposed solutions
Their support in
promoting the
PharmaLedger platform in
the EU
Internal
Meeting
CS trace, e-
PI, Anti-cft,
IoT
High 2021-Q1
EMVO Industry Medium
To keep informed of the project
status and the ways it impacts
pharma companies
Support for adoption,
high-level contacts, and
industry credibility
Internal
Meeting/
Report to the
Head of the
Organization
Anti-ctf Medium TBD

Engagement
approach
Relevant
use cases
Priority
level
Proposed
timeframe
EPF Patients High
Involve patient concerns in all
stages of development
Provide feedback for a
patient-centric
development
Internal
Meeting
None in
particular
Medium 2021-Q1
EU-PMHP Patients Medium
patient-centric
development
Internal
Meeting
IoT,
PersMed
High 2021-Q1
GIRP
Standardization
organization
Medium
activities of PharmaLedger
Formalizing the standards
created by PharmaLedger
Internal
Meeting
FG trace Medium TBD
GS1
Standardization
organization
Medium
Internal
Meeting/
Report to the
Head of the
Organization
CS trace, FG
trace, Anti-
ctf
High TBD
HAPC Industry Medium
To inform about project intentions
and the ways it may affect the
healthcare ecosystem in Greece
Their support can prove
useful in promoting the
Greece
Presentation to
their
Conference/
Report to the
Head/ Internal
Meeting
None in
particular
Low TBD
HL-7
Standardization
organization
High
Internal
Meeting/
Report to the
Head of the
Organization
FG Trace, CT
recruit, IoT,
Pers. Med
Mandatory 2021-Q1
HOPE Industry Medium
healthcare ecosystem
PharmaLedger platform
Internal
Meeting
None in
particular
Low TBD

Engagement
approach
Relevant
use cases
Priority
level
Proposed
timeframe
ICH-GCP
Standardization
organization
Medium
Advice on how GCP principles are
maintained and implemented
Internal
Meeting
IoT, CT
recruit, e-
consent, CS
trace,
PersMed
High 2021-Q1
IEEE
Standardization
organization
Medium
activities of PharmaLedger.
created by PharmaLedger.
Internal
Meeting/
Report to the
Head of the
Organization
All use cases High TBD
ISO
Standardization
organization
Medium
Internal
Meeting
None in
particular
Medium TBD
MfE Industry Medium
Internal
Meeting
e-PI Medium TBD
MHMD Research centre Medium
To keep informed of the activities of
PharmaLedger, leverage their
standards expertise
PharmaLedger and
supporting adoption
Internal
Meeting
IoT,
PersMed
Mandatory TBD
PGEU Industry Medium
Internal
Meeting
e-PI Medium TBD
PhUSE Research centre Medium
standards expertise
PharmaLedger and
supporting adoption
Internal
Meeting
None in
particular
Medium TBD

Annex II Overview of the other stakeholder groups and prioritization based on use cases
This Annex provides an overview of the other PharmaLedger’s stakeholders that are important for its regulatory and standardization strategy and identifies
who should be prioritized for proactive engagement based on the project’s use cases’ needs. This overview must be considered as a working document as it
may be updated and/or extended as the project matures, and the relative priority of engagement for each stakeholder will be assessed on an ongoing basis.
Engagement
approach
Relevant
use cases
Priority
level
Proposed
timeframe
ABPI Industry Medium
To inform of project intentions, and
keep updated with progress
Public support,
communication across
wider industry members
eNewsletter
None in
particular
Low TBD
DKMA
Policymaker/
Regulator
High
Support the design and
implementation of
within Denmark
Invite to the
internal
advisory board
None in
particular
Low TBD
EC
Policymaker/
Regulator
High
Support the adoption of
the PharmaLedger
platform across the EU
and increase public
awareness
All
communication
goes through
UPM as
coordinator
None in
particular
High TBD
EPF Patients High
patient-centric
development
Internal
Meeting
None in
particular
Medium 2021-Q1
FDA
Policymaker/
Regulator
High
Their support in
promoting the
the USA
Internal
Meeting
e-consent,
FP
traceability,
Anti-ctf
High TBD

Engagement
approach
Relevant
use cases
Priority
level
Proposed
timeframe
GHM
Policymaker/
Regulator
High
Their support will be
extremely useful in
implementing the
Greece, as well as
promoting it
Internal
Meeting/
Report to the
Minister
None in
particular
Low TBD
GMA
Policymaker/
Regulator
High
Increase visibility in
Greece, promote large-
scale adoption, provide
technical inputs,
deployment in multiple
sites in Greece
Invite to the
internal
advisory board
None in
particular
Low TBD
HAPC Industry Medium
Greece
Presentation to
their
Conference/
Report to the
Head/ Internal
Meeting
None in
particular
Low TBD
HTAC
Policymaker/
Regulator
High
Greece
Internal
Meeting/
Report to the
Head of the
Organization
None in
particular
Low TBD
ICO
Policymaker/
Regulator
High
Platform's compliance with
appropriate regulation for data
protection (currently GDPR)
the PharmaLedger
platform within the UK Press releases
None in
particular
Medium TBD

Engagement
approach
Relevant
use cases
Priority
level
Proposed
timeframe
MHMD
Research
centre
Medium
standards expertise
PharmaLedger and
supporting adoption
Internal
Meeting
IoT,
PersMed
Mandatory TBD
MHRA
Policymaker/
Regulator
High
Support the design and
implementation of
within the UK
Internal
Meeting
None in
particular
Low TBD
NAHS
Policymaker/
Regulator
Medium
useful in implementing the
Greece, as well as
promoting it.
Internal
Meeting/
Report to the
Head of the
Organization
None in
particular
Low TBD
NPHO
Policymaker/
Regulator
Medium
useful in implementing the
Greece, as well as
promoting it.
Internal
Meeting/
Report to the
Head of the
Organization
None in
particular
Low TBD
PAPI Industry Medium
Greece
Internal
Meeting/
Report to the
Head of the
Organization
None in
particular
Low TBD
PGEU Industry Medium
Internal
Meeting
e-PI Medium TBD

Engagement
approach
Relevant
use cases
Priority
level
Proposed
timeframe
PhUSE
Research
centre
Medium
standards expertise
PharmaLedger and
supporting adoption
Internal
Meeting
None in
particular
Medium TBD
SLA Industry Medium
Increase visibility and
support within the
Scottish Lifescience
Industry
eNewsletter
None in
particular
Low TBD
SPMS
Policymaker/
Regulator
High
healthcare ecosystem in Portugal
Increase visibility,
promote large-scale
adoption, provide
technical input,
deployment in multiple
sites in Portugal
Invite to the
internal
advisory board
None in
particular
Low TBD
UK
Department of
Health
Policymaker/
Regulator
High
the PharmaLedger
platform within the UK
Internal
Meeting
None in
particular
Low TBD
WHO
Policymaker/
Regulator
TBD TBD TBD TBD Anti-ctf Low TBD

PharmaLedger – First Report of Engagement of Regulatory and Standardization Strategy

Recommended

Recommended

More Related Content

What's hot

What's hot (15)

Similar to PharmaLedger – First Report of Engagement of Regulatory and Standardization Strategy

Similar to PharmaLedger – First Report of Engagement of Regulatory and Standardization Strategy (20)

More from PharmaLedger

More from PharmaLedger (12)

Recently uploaded

Recently uploaded (20)

PharmaLedger – First Report of Engagement of Regulatory and Standardization Strategy