Explaining EDCTP2 and its perspective on Capacity Building for PV of products used in managing PRDs

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1 Explaining EDCTP2 and its perspective on Capacity Building for PV of products used in managing PRDs 16 th Annual meeting of the International Society of Pharmacovigilance Jean Marie Vianney Habarugira, MSc Pharm. EDCTP Project Officer 17 October 2016, Agra-India

2 EDCTP The organisation The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public-public partnership between countries in Europe and sub-saharan Africa, and the European Union. EDCTP is a non- profit organisa2on

3 q EDCTP is a funding initiative established in 2003 by a co-decision of the European Parliament and Council under Article 185 (*) allowing EU's participation in research programmes undertaken by several European and Associated Member States (MSs) q Promote an integrated approach to health research in Europe to achieve greater impact against poverty-related diseases (PRDs) q In response to MDGs and global health crises caused by PRDs q Remediate sparse public investments and fragmented know-how q No economic incentive for private investments in PRDs q EDCTP1 ( ) q EDCTP2 ( ) Background (*) ex- Art. 169

4 EDCTP public-public partnership 14 European Countries Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden and United Kingdom 1 Aspirant Member Switzerland 14 African Countries Burkina Faso, Cameroon, Rep of Congo, Gabon, Ghana, Mali, Mozambique, Niger, Senegal, South Africa, Tanzania, The Gambia, Uganda, Zambia

5 The EDCTP programme

6 Funding of Infectious Disease R&D under Horizon 2020 PRODUCT DEVELOPMENT PIPELINE Discovery Proof of Concept Preclinical research Phase I/IIa Phase II Phase III Phase IV Commercial H2020 collaborative projects EDCT SME-Instrument P IMI-2 Innovation procurement

7 EDCTP target diseases HIV, tuberculosis, malaria Neglected infectious diseases Buruli ulcer; cysticercosis/taeniasis; dengue; dracunculiasis; echinococcosis; foodborne trematodiases; Hansen disease; human African trypanosomiasis; leishmaniasis; lymphatic filariasis; mycetoma; onchocerciasis; rabies; schistosomiasis; soil-transmitted helminthiases; trachoma; yaws Diarrhoeal diseases Lower respiratory tract infections Emerging and re-emerging infectious diseases of particular relevance for Africa, such as Ebola virus disease and yellow fever.

8 EDCTP strategy for capacity development

9 Addressing Poverty-related diseases and poverty-related PV EDCTP Strategic Business Plan [ ]EDCTP2 extends its portfolio to operational and implementation research on delivery and uptake of medical products, including postmarketing (phase IV) trials and collection of safety data that may be part of active pharmacovigilance and controlled community-based interventions. EDCTP2_Strategic_Business_Plan.pdf

10 Bottlenecks slowing down PV capacity in LMICs Lack of relevant policy and regulations Limited skilled and equipped PV professionals Lack of emphasis on PV in training curricula of health care professionals (HCPs) Paucity of pharmacovigilance funding opportunities in research and development grant funding programmes Weak infrastructure for pharmacovigilance to cope with rapidly advancing product development initiatives The limited pharmacovigilance awareness among HCPs The disconnect between research community, policy makers and regulatory bodies Source: unpublished Literature Review (EDCTP)

11 Latest evidence on weak PV for PRDs As at the end of September 2015, 35 African countries were Full Members of the WHO Programme for Interna2onal Drug Monitoring. The 35 countries from Africa have submired 103,499 (0.88 %) of the global total of 11,824,804 ICSRs in VigiBase_ submired by all 122 members of the PIDM African ICSRs are dominated by products for infecgous diseases, including HIV/ AIDS and an2bio2cs, while ICSRs from the rest of the world (RoW) are mainly in rela2on to TNFᵅ inhibitors, topical nonsteroidal an2- inflammatory drugs, immunosuppresants, selec2ve serotonin reuptake inhibitors and sta2ns.

12 EDCTP Call: Strategic actions supporting health systems/services optimisation research capacities in cooperation with development assistance initiatives Background Poverty-related diseases (PRDs) represent a huge burden in many communities in sub-saharan Africa. Investments for developing new drugs, vaccines, microbicides and diagnostics for PRDs are being made by various entities including pharmaceutical companies and public-private partnerships. Following registration of new and improved clinical interventions, there is a significant challenge of ensuring that these products reach the target populations and that their safety and effectiveness is assessed in real world settings.

13 EDCTP Call: Strategic actions supporting health systems/services optimisation research capacities in cooperation with development assistance initiatives Scope [ ] Proposals addressing one or both of the following topics are particularly encouraged: q Development of pharmacovigilance (PV) capacities in sub-saharan Africa Activities may include: Ø analysis of the current PV policies, regulations and infrastructure in sub-saharan African countries Ø implementation of tools, technologies or mechanisms to establish and/or improve the efficiency of systems for adverse event detection, reporting, analysis and dissemination to relevant stakeholders; Ø support of staff from sub-saharan African countries to attend training courses in established PV training centres.

14 The Expected Impact from funded research projects Actions funded under this Call should: Ø increase the readiness of health systems to introduce and absorb new interventions for PRDs Ø increase the coverage, accessibility and effectiveness of existing evidence-based interventions in endemic areas PV-related actions should contribute to: Ø establishment and/or strengthening of sentinel surveillance systems Ø to developing a cohort of PV-trained staff

15 The Call Budget and Timelines Budget Total Call Budget: 10 Million Maximum budget per grant: 3 Million Expected number of grants: 1-6 Timelines Stage 1 Launch: 14July 2016 Stage 1 Closed: 29 September 2016 Stage 2 Opening: 22 December 2016 Stage 2 Closing: 2 March 2017.

16 Other Calls addressing PV capacity : EDCTP Regional Networks The specific objecgves of the networks should include: [ ] q To offer training and mentorship in Key Skills : ü Design of clinical trials ü Monitoring ü Data management ü Pharmacokine2cs ü Laboratory techniques ü Biosta2s2cs ü Clinical epidemiology ü Pharmacovigilance ü Financial management ü Administra2on and quality assurance. Ø Call Budget: Euro Ø Max budget per grant: Euro Ø Closed Call.

17 Other Calls addressing PV capacity : Ethics and regulatory capacities The objecgves of this call are: [ ] q To support NRAs development of ins2tu2onal and personnel capaci2es to enable improved regulatory pathway ac2vi2es directly related to clinical trials and registra2on of new medicinal products. This may also include strengthening pharmacovigilance systems. Ø Launched every year Ø Call Budget: Euro Ø Max budget per grant: Euro Ø Currently open; Closing date 22 November 2016

18 THANK YOU