Governance structure

The PROTECT governance structure is a multi-layer structure comprising three components:

Governance and scientific oversight

• Consortium Assembly
• External Advisory Board
• Steering Committee

Project management & administration

• Coordinator and Deputy Coordinator
• Project Management Support Team
• Managing Entity of the IMI JU fund
• Work Package co-Leaders

Project implementation

• All Work Package members
• Extended Audience

The interactions between the involved structures are depicted in the following diagram:

The Consortium Assembly

The Consortium Assembly includes one representative from each PROTECT participant and meets, in principle, once a year.

Main roles and responsibilities:

• Adoption of the annual budget;
• Review of the Project Management Plan, progress reports and the deliverables;
• Comment on the steps proposed to be undertaken to achieve the project's objectives;
• Recommendations to the Steering Committee regarding e.g. the overall strategy of the project, entry/withdrawal of a participant to/from the consortium, remedies to be performed by a defaulting party, proposal for a change of Coordinator, proposal for dissemination and publication of deliverables or for arbitration of any disputes between participants.

The External Advisory Board (EAB)

The External Advisory Board includes ten international experts in the area of pharmacovigilance, pharmacoepidemiology, biostatistics, benefit-risk assessment and public health, nominated by the public and private consortiums to provide advice to the PROTECT project.

The EAB will normally meet once a year, with one additional meeting in the first and the fifth year in order to provide guidance in critical periods of the research programme.

Main roles and responsibilities:

• Identification of any critical step, activity or missing element in the work programme that may represent a risk for the realisation of the scientific programme, or that may affect its quality or implementation; proposal of possible remedial actions to the Steering Committee;
• General guidance and recommendations regarding scientific, technical and ethical aspects of the work programme;
• Recommendations to the Steering Committee on specific aspects;
• As necessary, consultation of additional experts on specific aspects of the work programme;
• Input to the Steering Committee regarding non-European research programmes with similar objectives and scope, and advice on opportunities for collaboration;
• Advice to the Steering Committee on the communication and dissemination of outcomes achieved by the consortium.

The PROTECT EAB is composed of:

Name	Affiliation	Expertise
Corinne De Vries, PhD	Department of Pharmacy and Pharmacology, University of Bath, UK	Pharmacoepidemiology
Trevor Gibbs, MD	Former Head of Global Pharmacovigilance and Product Safety, GSK, UK; Chief Medical Officer at ii4sm	Pharmacovigilance, health outcomes, public health
David Haerry	European AIDS Treatment Group (EATG), Brussels, Belgium	Pharmacoepidemiology
Vicky Hogan, PhD	Director, Office of Risk Management and Science, Marketed Health Products Directorate (MHPD), Health Canada	Benefit-risk assessment
Michael Lewis, MD	EPES Epidemiology, Pharmacoepidemiology and Systems Research GmbH, Berlin, Germany	Pharmacoepidemiology
Allen Mitchell, MD	Slone Epidemiology Center, Boston, USA	Perinatal epidemiology, pharmacoepidemiology
Marcus Müllner, MD	Head of AGES PharmMed (Austrian Medicines and Medical Devices Agency), Austria	Benefit-risk assessment, clinical epidemiology, pharmacovigilance
Gerald Dal Pan, M.D., M.H.S.	Director, Office of Drug Safety, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USA	Pharmacovigilance, drug development, public health & risk management
Munir Pirmohamed, MD	Department of Pharmacology and Therapeutics, University of Liverpool, UK	Pharmacology, pharmacovigilance
Samy Suissa, PhD	Department of Epidemiology/Biostatistics, McGill University, Montreal, Canada	Pharmacoepidemiology, Biostatistics

The Steering Committee

The Steering Committee has the central role in the governance structure and the management of the project. The Steering Committee includes all Work Package co-Leaders, the Coordinator, the Deputy Coordinator and their Alternates.

During the initiation phase of the project, the Steering Committee will in principle meet every month. In the following years, the Steering Committee will meet at least four times annually.

Main roles and responsibilities:

• Finalisation and approval of the PROTECT Management Plan;
• Decisions for the initiation and execution of the activities included in the Project Management Plan;
• Approval of the budget allocation to Work Package members and the in-kind contribution from private partners;
• Review of the progress and of the quality control findings of the work programme;
• Discussion of recommendations proposed by the External Advisory Board and the Consortium Assembly;
• Decisions regarding communication and dissemination of the project deliverables;
• Discussion of problems and conflicts that may arise during the course of the programme when these have not been solved by the Coordinator and the Deputy Coordinator;
• Decisions regarding the admission of new partners from the Extended Audience.

The Coordinator

The Coordinator is responsible for the successful management and delivery of the project. He is the contact point for discussions with the IMI JU and is in charge of the execution of the work plan with the Work Package co-Leaders and of the implementation of the decisions taken by the Steering Committee. The Coordinator is responsible for the overall governance of PROTECT.

The Deputy Coordinator

The Deputy Coordinator has three main roles: to coordinate the input (scientific and in-kind) from the private consortium (i.e. industry partners) , to support the Coordinator with the development and implementation of the Project Management Plan and delivery of outcomes, to support the Coordinator with governance of PROTECT and be involved in decision making of the project.

Work Package co-Leaders

Work Package	Co-Leaders	Partner
WP1	Xavier Kurz	EMA
	Elizabeth Swain	GSK
WP2	Olaf Klungel	UU
	Robert Reynolds	Pfizer
WP3	Niklas Norén	UMC
	Michael Kayser	BSP
WP4	Stella Blackburn	EMA
	Jens Peter Balling	HLU
WP5	Deborah Ashby	Imperial
	Alain Micaleff	ME
WP6	Lucien Abenhaim	PGRx(LASER)
	Laurent Auclert	SARD
WP7	Joan-Ramon Laporte	FICF
	Elena Rivero	Novartis Pharma

Extended Audience

Members of the Extended Audience are European centres which have established or have access to specific clinical trial data, patient registries, cohorts or case-control resources, or individuals with expertise in specific domains to be addressed by WP6 (pharmacology, clinical expertise, pharmacoepidemiology).

---