The Europe-Africa Oncology Alliance

The Europe-Africa Oncology Alliance

Building a shared ecosystem for oncology research, training, and patient-centered care between Europe and Africa.

ABOUT THE PROJECT

The Europe–Africa Oncology Alliance is an international cooperation platform dedicated to advancing cancer research, education, and patient-centered care across continents.

It was developed by ISHEO, building on the success and methodology of its flagship initiative, BRIDGE THE GAP, a multistakeholder program launched in Italy in 2022 that connects clinicians, patient associations, healthcare managers, industry leaders, and institutions to overcome barriers in oncology care and clinical research.

Thanks to this experience, ISHEO now extends that proven collaborative model to a broader international scale, turning shared expertise into a bridge between continents.

VISION AND PURPOSE

The Alliance aims to strengthen cooperation among research centers and hospitals, patient associations and advocacy groups, CROs and CDMOs, laboratories, investors, pharmaceutical and biotech companies, regulators, educators, and healthcare managers throughout Europe and Africa.

Its overarching goal is to build a shared ecosystem of innovation and equity in oncology—fostering dialogue, capacity building, and joint action to improve outcomes for patients affected by non-communicable diseases (NCDs), with a particular focus on oncological, onco-hematological, and rare diseases.

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WHAT WE DO

The Europe–Africa Oncology Alliance provides a framework for collaboration through:

Joint clinical research and innovation projects that strengthen local research capacity;
Advanced training programs for healthcare professionals and researchers;
Policy dialogue that supports alignment of regulatory and ethical standards;
Knowledge-sharing initiatives that promote equitable access to new therapies.

Through education and awareness campaigns, the promotion of pharmaceutical and biotechnological innovation, and the evaluation of their impact on health outcomes, the Alliance seeks to advance access to care, improve patient journeys, and enhance quality of life across diverse healthcare systems.

A BRIDGE BETWEEN CONTINENTS

Acting as both a knowledge hub and a collaborative engine, the Europe–Africa Oncology Alliance translates cooperation into new, patient-centered models of care adapted to local contexts.

It embodies ISHEO’s long-standing commitment to dialogue, innovation, and sustainability in health systems– transforming collaboration into impact and building a stronger, more connected oncology ecosystem for the future.

OUR PROJECTS

1. EMEA CLINICAL RESEARCH TRAINING & EXCELLENCE ACADEMY

A network for excellence in clinical research training, linking European, Middle East and African centers to share competencies, standards, and methodologies.

GOALS
- Build local research capacity.
- Provide advanced professional training.
- Harmonize clinical-research processes through experience sharing and best practices.
FORMAT
- Courses delivered live or online (synchronous e-learning) to ensure interactive participation.
- Faculty: Experts from CROs, regulatory bodies, pharmaceutical companies, and academic research centers.
- Languages: English, French, Italian.

FROM TRAINING NEEDS ASSESSMENT TO TAILORED LEARNING PROGRAMS

Learning programs can be tailored following a comprehensive training needs assessment, conducted through interviews and discussions with prospective participants and institutional partners.

This process allows the identification of specific learning priorities, skills gaps, and operational contexts relevant to each organization or research team.

Based on these findings, the final training program is then structured and delivered by selecting and adapting the most relevant modules from the core curriculum, ensuring that the content is directly aligned with participants professional objectives and the strategic goals of their working team. professionals such as Clinical Research Associates, Clinical Project Managers, Data Managers, and Clinical Research Coordinators, as well as programs on Good Clinical Practice (GCP) and clinical study design.

1

Clinical Research Governance and EU Regulatory Framework

European regulatory architecture: EU Regulation 536/2014, the role of EMA and CTIS, and alignment with the African Medicines Agency (AMA).

Objective: to transfer competencies needed to conduct studies compliant with EU standards.

2

ICH-GCP E6(R3) and E8(R1) Implementation

Practical application of the new Good Clinical Practice guidelines, focusing on Quality by Design, risk management, and patient centrality.

Objective: to ensure compliance with the most recent international standards

3

Clinical Study Start-Up

Procedures for study initiation, feasibility assessment, investigator selection, ethics submission, and management of multicenter research sites.

Objective: to build operational capabilities for transnational clinical trials.

4

Data Management & Clinical Data Integrity

Use of eCRF, EDC, and eTMF systems compliant with GxP and GDPR within the EU framework.

Objective: to ensure quality, traceability, and data security in clinical studies.

5

Quality Assurance & Quality Control

System audits, CAPA management, vendor oversight, and preparation for EMA/FDA inspections.

Objective: to strengthen the culture of quality within research centers.

6

Clinical Project and Operations Management (CPM)

Planning, risk management, monitoring, and reporting for multicenter studies.

Objective: to train coordination roles such as Clinical Project Managers and Operations Leads.

7

Clinical Trial Monitoring & Remote Oversight

On-site and centralized monitoring techniques aligned with GCP E6(R3).

Objective: to optimize quality control in decentralized or resource-limited studies.

8

Good Documentation Practice & Trial Master File Management

Documentation management in compliance with ALCOA+ standards, archiving, and audit readiness.

Objective: to maintain compliance and traceability throughout the study lifecycle.

9

Risk-Based Monitoring and Quality by Design in Clinical Trials

A modern approach to risk management and quality planning.

Objective: to increase efficiency and data robustness.

10

Ethical and Cultural Dimensions in Multiregional Trials

Informed consent processes, community engagement, and respect for local contexts.

Objective: to promote ethical and culturally sensitive clinical research.

11

GDPR and Data Protection in Global Health Research

Protection of personal data and cybersecurity in international trials.

Objective: to harmonize data-privacy practices between the EU, Middle East and Africa.

12

Training for Investigators and Site Coordinators

Specific training for Principal Investigators, Sub-Investigators, and site coordinators, including case studies and simulations.

Objective: to standardize trial management and improve site performance.

EXPECTED OUTCOMES

These training programs serve as a practical bridge between the European, Middle East and African regulatory and research ecosystems, promoting:

Strengthening of local expertise
Compliance with international quality and regulatory standards
Best practice sharing
Cross-regional collaboration
Capacity building for sustainable clinical research projects and health innovation management
Empowerment of multidisciplinary teams and organizational learning

TARGET PARTICIPANTS

The training courses are designed for:

- Clinical research teams within hospitals, care centers, and Middle East and African clinical institutions interested in initiating or strengthening their participation in clinical trials, health outcomes research, and observational or safety studies, whether investigator-initiated or sponsored.
- Pharmaceutical, biotechnology, and biomedical companies engaged in clinical development projects involving research centers in the EMEA region (Europe, Middle East, and Africa).
- Individual professionals seeking to enter or enhance their expertise in clinical research management as Principal Investigators, Clinical Research Associates, Project Managers, Quality Assurance Specialists, Data Managers, Biostatisticians, or Medical Writers.
- HTA and Market Access professionals developing evidence-based access and reimbursement strategies.
- Public health, regulatory, and policy experts, as well as patient advocacy leaders and stakeholder engagement professionals.

The network draws on the expertise of CRES Academy, which since 2015 has been designing and delivering tailored courses for research centers and professionals such as Clinical Research Associates, Clinical Project Managers, Data Managers, and Clinical Research Coordinators, as well as programs on Good Clinical Practice (GCP) and clinical study design.

Through this work, the Academy fosters cooperation, innovation, and mutual development between Europe, Middle East and Africa.

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2. AFRICA ONCOLOGY SUMMIT

A pan-African summit on oncology and non-communicable diseases (NCDs) bringing together healthcare professionals, policymakers, patient advocates, researchers, and industry leaders from across the continent and beyond.

The Summit is designed to:

Share best practices and success stories in cancer prevention, diagnosis, care, and research across diverse African contexts.
Discuss barriers to equitable treatment access, including regulatory challenges, infrastructure limitations, and patient support needs.
Promote collaborative initiatives in clinical research, education, digital health, and health policy, fostering sustainable partnerships between African and international institutions.
Highlight innovations and capacity-building efforts that can transform oncology care in low- and middle-income countries.

PURPOSE

The overarching goal of the Africa Oncology Summit is to accelerate equitable access to therapies and to strengthen health system capacity for the management of non-communicable diseases — starting with hematologic and oncologic conditions.

By creating a platform for dialogue, knowledge exchange, and coordinated action, the Summit aims to inspire a new generation of partnerships that translate research excellence into improved patient outcomes and quality of life across the African continent.