meeting of regional centres of regulatory excellence (rcores) in

NEPAD PLANNING AND COORDINATING AGENCY

Meeting of the NEPAD Regional Centers of Regulatory Excellence (RCORES) in Pharmacovigilance May 14–15, 2015, Accra, Ghana Report of Proceedings

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This report is made possible by the generous support of the American people through the US Agency for International Development (USAID), under the terms of cooperative agreement number AID-OAA-A-11-00021. The contents are the responsibility of Management Sciences for Health and do not necessarily reflect the views of USAID or the United States Government. About SIAPS The goal of the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program is to assure the availability of quality pharmaceutical products and effective pharmaceutical services to achieve desired health outcomes. Toward this end, the SIAPS result areas include improving governance, building capacity for pharmaceutical management and services, addressing information needed for decision-making in the pharmaceutical sector, strengthening financing strategies and mechanisms to improve access to medicines, and increasing quality pharmaceutical services. About NEPAD and AMRH The New Partnership for Africa's Development (NEPAD), an African Union strategic framework for pan-African socio-economic development, is both a vision and a policy framework for Africa in the twenty-first century. The African Medicines Regulatory Harmonization (AMRH) Programme has been established to operationalize the African Union's Pharmaceutical Manufacturing Plan for Africa (PMPA), which seeks to enable African countries to fulfill their national obligations to provide all citizens with safe, quality and efficacious essential medicines. NEPAD Agency in collaboration with partners, is working through the AMRH Programme, to support African Regional Economic Communities (RECs) and countries to lead medicines regulatory harmonization in their respective countries and to respond to the challenges of increasing access to essential medicines. Recommended Citation This report may be reproduced if credit is given to SIAPS. Please use the following citation. Report of Meeting of African Union and New Partnership for African Development’s Regional Centers of Regulatory Excellence (RCOREs) in Pharmacovigilance, May 14–15 2015, Accra, Ghana. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health. Key Words New Partnership for Africa’s Development, Regional Centres of Regulatory Excellence (RCORE), pharmacovigilance, African Medicines Registration Harmonization Programme (AMRH), SIAPS

Systems for Improved Access to Pharmaceuticals and Services Center for Pharmaceutical Management

Management Sciences for Health 4301 North Fairfax Drive, Suite 400

Arlington, VA 22203 USA Telephone: 703.524.6575

Fax: 703.524.7898 E-mail: [email protected]

Website: www.siapsprogram.org

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TABLE OF CONTENTS

Acronyms and Abbreviations ................................................................................................... iv

Executive Summary ................................................................................................................... v Recommendations .................................................................................................................. v Next Steps ............................................................................................................................ vii

Introduction ................................................................................................................................ 1 Meeting Objectives, Expected Outputs, and Meeting Format ............................................... 2

Accra Meeting Proceedings—Day 1 ......................................................................................... 3 Opening Remarks ................................................................................................................... 3 PV-RCOREs: Purpose and Role —AMRH ........................................................................... 5 PV Agenda for Africa: Role of Partners ................................................................................ 6 Presentations on PV Agenda for Africa and the Role of Partners ......................................... 6 Discussion on PV Agenda for Africa and the Role of Partners ............................................. 7 PV-RCOREs Presentations .................................................................................................... 7 Governance Structure and Linkages of the PV-RCOREs ...................................................... 8

Accra Meeting Proceedings—Day 2 ....................................................................................... 10 Harmonization of PV activities in EAC Partner States ........................................................ 10 Building Capacity for PV in Africa ...................................................................................... 10 Work Plan Development and Funding for PV-RCOREs ..................................................... 11 Closing ................................................................................................................................. 12

Recommendations .................................................................................................................... 13 Next Steps ............................................................................................................................ 14

Annex A. List of Attendees ..................................................................................................... 15

Annex B: Agenda ..................................................................................................................... 16 14 May 2015 | Day One ..................................................................................................... 16 15 May 2015 | Day Two ..................................................................................................... 17

Annex C: Concept Note ........................................................................................................... 18

Annex D: NEPAD Agency Designated Regional Centres of Regulatory Excellence (RCORES) ............................................................................................................................... 22

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ACRONYMS AND ABBREVIATIONS

AMRH African Medicines Regulatory Harmonization Programme EAC East Africa Community EDCTP European and Developing Countries Clinical Trials Partnership MCAZ Medicines Control Authority of Zimbabwe MSH Management Sciences for Health NAFDAC National Agency for Food and Drug Administration and Control NEPAD New Partnership for Africa’s Development NMRA National Medicines Regulatory Authority PMS Post Marketing Surveillance PPB Pharmacy and Poisons Board PV Pharmacovigilance RCORE Regional Centers of Regulatory Excellence SIAPS Systems for Improved Access to Pharmaceuticals and Services [Program] TFDA Tanzania Food and Drugs Authority TWG Technical Working Group UMC Uppsala Monitoring Centre UON University of Nairobi USAID United States Agency for International Development WAHO West African Health Organization WHO World Health Organization WHO-CC World Health Organization Collaborating Centre for Advocacy and Training

in Pharmacovigilance

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EXECUTIVE SUMMARY The African Medicines Registration Harmonization (AMRH) Programme, of the African Union as well as AMRH’s Regional Centers of Regulatory Excellence (RCORE) in pharmacovigilance (PV), and the US Agency for International Development (USAID)-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program met in Accra, Ghana, May 14–15, 2015, to discuss the future for PV systems strengthening in Africa. The meeting, which was hosted by the World Health Organization (WHO) Collaborating Centre for Advocacy and Training in Pharmacovigilance (WHO-CC), at the Novotel Hotel, Accra and saw key individuals from the PV-RCORES, East Africa Community (EAC), WAHO, EDTCP, NEPAD/AMRH, USAID/SIAPS, USAID/Accra, World Bank, and WHO Headquarters, Geneva in attendance. The meeting covered—

• Purpose and role of the PV-RCOREs

• Africa’s PV agenda and the role of partners

• Capacity building activities in the PV-RCOREs

• Framework for governance of PV-RCOREs and coordination of PV activities in Africa

The two designated PV-RCORES namely, the WHO-CC and its consortium members on one hand and the Kenya PPB on the other, presented their on-going capacity building efforts, planned activities, governance structures and linkages. Technical partners and donors also participated and provided inputs into the PV agenda for Africa, governance of the PV-RCOREs, and resource mobilization for PV in Africa. Recommendations At the end of the two-day meeting, participants agreed on the following recommendations with the lead agencies/organizations for their implementation in brackets as shown below:

• Ensure that all countries in Africa have a national PV system which works with the WHO Programme for International Drug Monitoring (WHO, AMRH, PV-RCORES, SIAPS)

• Harmonize PV guidelines and requirements on the continent to ensure the availability of complementary and simplified guidelines that will be well publicized for use by national regulatory agencies, marketing authorization holders and all other stakeholders in PV in Africa (PV-RCORES, AMRH)

• Establish clear metrics for assessing RCORE performance (lead: AMRH upon discussion with PV-RCORES)

NEPAD Planning and Coordinating Agency

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• Use of existing tools including the Indicator-Based Pharmacovigilance Assessment Tool (IPAT) and the WHO PV indicators to assess national PV centers (PV-RCOREs, USAID/SIAPS, WHO, Uppsala Monitoring Center (UMC)

• Map all ongoing PV activities and tools in Africa to foster collaborations and reduce duplications (SIAPS, PPB, WHO-CC, AMRH)

• Harmonize tools and indicators used for PV in Africa (PV-RCOREs; AMRH; SIAPS)

• Establish a database of PV experts in Africa (AMRH, WHO-CC Africa, WHO; UMC; SIAPS)

• Establish within each regional economic community an expert/technical working group (EWG/TWG) on PV with representations from member countries (AMRH, Regional Economic Communities)

• Establish an African Technical Working Group on PV comprising members from the regional Expert Working Groups as well as the PV-RCOREs (AMRH) with international partners including WHO, UMC, SIAPS, MSH as observers

• Formalize the relationship between PV-RCOREs and regional economic blocs e.g., EAC and ECOWAS (AMRH, EAC, WAHO)

• Develop and disseminate transparent and mature governance structures to drive the PV agenda for Africa while ensuring sustainability of PV-RCOREs and obtaining buy-in from external partners (PV-RCOREs, AMRH)

• Develop, field-test, and deploy tools for PV in Africa (SIAPS, UMC, WHO-CC, PPB)

• Develop capacity for risk management and communication in all national PV centers (AMRH, PV-RCOREs)

• Open flow of information between countries and partners to avoid duplication and contradictions (all)

• Hold serious and open discussions among all stakeholders to constructively work together to fill the gaps and build PV systems for the future in Africa (AMRH, WHO, SIAPS, UMC, World Bank)

• Gather support from multilateral and bilateral agencies as well as international partners to complement the investments of individual governments in PV (World Bank, AMRH, WHO, SIAPS)

• Mobilize financial and technical resources for PV-RCOREs sourcing funds for the operation of the governance systems in each RCORE (AMRH)

Executive Summary

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Next Steps The following next steps were proposed:

• Clearly specify and agree on the governance structure of each RCORE and the role of each partner

• Agree on and disseminate the PV vision for Africa and what it seeks to achieve in the short, medium, and long term

• Map the existing PV infrastructure in Africa including the trained personnel, training facilities and institutions, tools, methods and expertise

• Agree on the content of the core curriculum for PV personnel in Africa ensuring it also includes the required body of knowledge specified by the AMRH

• Develop an advocacy and resource mobilization strategy by each RCORE

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INTRODUCTION

In May 2014, the New Partnership for Africa’s Development (NEPAD) Agency designated the World Health Organization (WHO) Collaborating Centre for Advocacy and Training in Pharmacovigilance (CC) at the University of Ghana, and the Pharmacy and Poisons Board (PPB) of Kenya as Regional Centers of Regulatory Excellence (RCOREs) in Pharmacovigilance. The WHO-CC RCORE is a consortium involving the WHO-CC, the National Pharmacovigilance Centers of Ghana, Nigeria, Tanzania, and Zimbabwe, as well as Sante-Afrique International Limited of Ghana and Quintiles Clyndepharm of South Africa. RCOREs are part of the AMRH strategy for increasing human and institutional capacity for regulating medical products and technologies. RCOREs works to realize the African Union’s vision of improving public health on the continent by increasing access to medicines for key priority high burden diseases on the continent. This vision, as articulated by the Pharmaceutical Manufacturing Plan for Africa, is informed by the need to create a conducive regulatory environment on the continent as part of the overall process of strengthening the continent’s ability to produce high quality, affordable essential medicines and other health commodities. To date, 10 RCOREs have been designated to cover various areas of medicine regulation (see www.amrh.org for details of the RCOREs). The designation of two RCOREs for PV shows the importance attached to safety monitoring by the AMRH Program. The PV-RCOREs are expected to take leadership in cultivating PV in Africa through training, capacity building, methods development and tools research, development, publication, and advocacy. The guideline governing RCOREs was published in 2014 and it specifies the basis for RCORE selection, the period of designation of RCORE status and the expected activities. RCORE designation does not come associated with any financial commitments from AMRH. However, the AMRH has categorically stated its aim to ensure the viability of RCOREs by seeking financial and technical support for the activities of all RCOREs. On February 19, 2015, during a consultation meeting of RCOREs and potential funding agencies held in Cape Town, South Africa, a side meeting was held between the NEPAD-designated RCOREs in PV and the US Agency for International Development (USAID)-funded Systems for Improved Access to Pharmaceutical and Services (SIAPS) Program. The meeting participants were drawn from NEPAD Agency, SIAPS, WHO-CC Ghana and its consortium partners, and the Kenya PPB. Meeting participants discussed potential areas of collaboration including enhancing networking and close collaboration between the PV-RCORES, especially between the Kenya PPB and Ghana WHO-CC Consortium; ensuring synergies between the activities of the PPB, WHO-CC, and the East African Community (EAC); development of PV training of trainers program; collaboration for country support; PV consultants network; PV information system; customization and validation of IPAT, and the WHO PV indicators for the AMRH initiative. These discussions led to the recommendation that there be a dedicated meeting for the RCOREs in PV, which was eventually held in Accra May 14–15, 2015. This report highlights the discussions and outcomes of the meeting. The meeting’s final agenda (annex B) and concept note (annex C) are attached.

http://www.amrh.org/


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Meeting Objectives, Expected Outputs, and Meeting Format Specific Objectives

1. Review on-going regulatory capacity building activities in the PV-RCOREs and mobilize partners in their support

2. Agree on a framework for governance and coordination of PV activities in Africa

3. Develop work plan for 2015–2016 for PV-RCOREs

Expected Outputs The expected outputs of the meeting were—

• PV agenda for Africa and the roles of partners reviewed • Capacity-building activities in PV carried out or to be carried out by the PV-RCOREs • Governance structure and linkages for PV in Africa agreed upon • 2015–2016 work plan for PV-RCOREs developed • Funding for PV-RCOREs discussed and agreed upon

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ACCRA MEETING PROCEEDINGS—DAY 1 The meeting took place at the Novotel Hotel in Accra, Ghana from May 14–15, 2015, and included plenary presentations, open discussions, and group work. The full list of participants is attached (annex A). The meeting opened with remarks by the NEPAD AMRH Program Partners. Following are summaries of the presentation from the participating organizations. Opening Remarks NEPAD Agency NEPAD stated that regional integration and harmonization is one way to address PV issues. A framework to drive PV in Africa is critical and necessary to take advantage of existing opportunities in advancing PV on the continent. World Health Organization, Headquarters, Geneva WHO-HQ remarked that setting up the RCOREs to lead PV initiatives was commendable. The importance of empowering regulators in making quality decisions on medicinal products was stressed as well as the need to ensure sustainability in the efforts and investments being made. World Bank The World Bank representative welcomed the progress made on the continent and highlighted the fact that more resources would be needed for PV and that all partners needed to work on sustainable approaches to resource mobilization. West African Health Organisation The Director-General of the West African Health Organization (WAHO) who was present in person indicated that the organization appreciated the opportunity to be part of the workshop and pledged WAHO’s commitment to building strong regulatory and PV infrastructure in West Africa. WAHO’s investments in capacity building in PV in West African were highlighted. WAHO called for collaboration with partners to strengthen PV in the sub-region. Ghana Food and Drugs Authority As the host regulatory agency, the Ghana Food and Drug Authority (FDA), welcomed participants to Ghana and asked that countries in Africa take PV seriously in view of the impending launch of several new pharmaceuticals including vaccines in Africa. Some of these products are being used first in Africa with no experience of use anywhere else. Africa cannot therefore rely on the safety experience with these medicines from other regions or countries. The CEO of the FDA highlighted a new initiative in Ghana to ensure that all marketing authorization holders have a qualified person for pharmacovigilance (QPPV) who


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should reside in Ghana and is responsible for safety monitoring of the company’s registered products. European and Developing Countries Clinical Trials Partnership European and Developing Countries Clinical Trials Partnership (EDCTP) stated its intention to support PV as part of phase 2 of EDCTP (EDCTP II) and requested participants to check its website for grant calls that would be made in regulatory capacity building including PV. Pharmacy and Poisons Board of Kenya PV landscape has changed so new skills and tools for PV are desirable. Kenya PPB collaborates with University of Nairobi (UON) to run a master of science program in PV and pharmaco-epidemiology. The PPB also intends to start a mandatory QPPV program in Kenya. National Agency for Food and Drugs Administration and Control, Nigeria The Nigerian National Agency for Food and Drugs Administration and Control stated its gratitude to NEPAD for putting in place a platform for PV and pledged to share its experience in PV policy development with other countries. It also offered support in research as well as training in PV. Medicines Control Authority of Zimbabwe (MCAZ) The MCAZ is acutely aware of the challenges in PV. There is therefore the need to build upon the work undertaken by MCAZ either alone or in collaboration with other partners to improve PV in Zimbabwe, the southern Africa region and Africa as a whole. Tanzania Food and Drugs Authority The Tanzania Food and Drugs Authority was appreciative to WHO for PV support and NEPAD for the initiatives. Quintiles PLC As part of the RCORE in PV Consortium, Quintiles, which already works closely with WHO-CC, will support capacity building in PV across the continent. In particular, Quintiles will like to see an increase in the number of individual case safety reports (ICSRs) reported from African countries as higher numbers of cases will assist regulators to make quality decisions on medicinal products. The organisation also advocates for effective promotion of adverse drug reaction reporting. SIAPS SIAPS has a keen interest in ensuring the regular availability of quality assured essential medicines and other health technologies critical to the attainment of health outcomes, and that these commodities are rationally used. In addition, SIAPS works with partners to build regulatory capacity, patient safety systems, and data systems to ensure ready availability of data to support evidence-based decision making. In Africa, SIAPS has been building capacity

Accra Meeting Proceedings—Day 1

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in several countries for a system-wide approach to managing pharmaceuticals. In relation to the AMRH RCORE program, SIAPS has a stated interest in providing support for building regulatory capacity and also specific support to the activities of the two PV-RCOREs. SIAPS will collaborate with the PV-RCOREs to provide support, technical assistance, training, and tools as required by countries and in consultation with all parties. Uppsala Monitoring Centre, Sweden The Uppsala Monitoring Centre (UMC) through a message from its Director welcomed the RCORE initiative and encouraged all partners including WHO, SIAPS, MSH and the PV RCOREs to accept the view that the tasks involved in PV development and improvement involves active collaboration between all partners. The UMC therefore called for a new environment where partners would collaborate to avoid duplication and cooperate for success based on clear objectives, metrics and expectations. USAID West Africa An official from the USAID West Africa Program remarked that the safety of medicines and other health commodities is critical to the success of USAID programs in Africa. Though USAID is working in several different areas, its support for the HIV and AIDS programs means that it is involved in the supply of millions of doses of antiretrovirals and other medicines and thus sees safety monitoring as critical to the success of its program. USAID called for collaboration of all partners to ensure that available resources are used optimally. PV-RCOREs: Purpose and Role — MRH AMRH staff gave a presentation on the purpose and role of RCOREs. AMRH noted that RCOREs are conceived as a model for sustainable regulatory capacity development in Africa as part of the overall Pharmaceutical Manufacturing Plan for Africa (PMPA) of the African Union. In May 2014, 10 RCOREs were designated focusing on the different areas of regulatory functions with a goal of providing hands-on training in regulatory science. The rationale and purpose for establishing RCOREs was highlighted as to assist in building a strong regulatory workforce for pharmaceuticals and medical products in Africa through—

• Provision of academic and technical training in regulatory science applicable to different regulatory functions and managerial aspects

• Skills enhancement through hands-on training, twining, and exchange programs among National Regulatory Medicines Agencies (NMRAs)

• Practical training through placement in the pharmaceutical industry

• Execution of operational research to pilot-test innovations and interventions to inform best practices for scale up to other NMRAs.

After the presentation, the main questions concerned the next steps for the PV-RCOREs and how they would perform. Participants strongly recommended that clear metrics be established for assessing RCORE performance. The AMRH had requested and received two-year costed work plans from all the RCOREs including the PV-RCOREs; these will provide preliminary


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basis for the assessment of performance. Partners were requested to support the work plans appropriately with the necessary resources. PV Agenda for Africa: Role of Partners Participants discussed their views on the PV agenda for Africa and how partners could work together for success. The main point was that African countries should be clear on their priorities and expectations from any PV initiative. Countries and partners were asked to ensure open flow of information so that duplications and contradictions could be reduced. The effects of PV outputs on overall health systems on the continent were also discussed in detail. Currently, several PV activities are donor-driven and countries were asked to take both ownership and leadership to ensure the deployment of sustainable systems in their countries. With the high circulation of unauthorized medicines in Africa, countries were encouraged to develop comprehensive systems to deal with both the safety and quality of medicines. Having strong PV systems appears to be one way for NMRAs to detect unregistered, unauthorized, and sub-standard products circulating in their markets. Presentations on PV Agenda for Africa and the Role of Partners WHO-HQ The Medicines Safety and Safety and Vigilance roles, activities and achievements in PV in Africa of WHO-HQ were highlighted. Over the years, WHO has built a steadily growing infrastructure of national centers and PV experts in Africa and called for partners to support it in this work. WHO is the UN agency responsible for norms and standards in health and countries benefit immensely from participating in the WHO Program for International Drug Monitoring (PIDM). Currently, however, only 34 out of 55 countries in Africa are full member countries of the PIDM and there is the need to bring in all countries in as well as strengthen the PV activities of existing countries. PV capacity building in Africa remains a key priority for the WHO. SIAPS SIAPS has been supporting several countries in Africa to build PV systems. SIAPS has assisted with developing educational curriculum and programs (including the Master of Science Program at UON) and has developed and disseminated the IPAT to help countries measure the performance of their PV systems. SIAPS has also carried out a detailed survey of PV activities in sub-Saharan Africa and discovered weaknesses in several areas including the legislative framework and the functioning of national PV systems. Risk management and communication were identified as some of the weakest components of PV in sub-Saharan Africa. NEPAD Agency and AMRH The AMRH Program provides a basis for creation of regional agencies such as the East African Community Medicines and Food Safety Commission and, in the future, the African Medicines Agency. The AMRH’s vision for PV in Africa involves the use of the two PV-RCOREs to drive the PV agenda. The AMRH called for the use of existing tools including


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IPAT and the WHO PV indicators and asked the RCOREs to work towards harmonization of the various tools and processes used in PV on the continent. The AMRH highlighted the roles of the various partners in PV including the regional economic communities, the NEPAD Agency, WHO, and World Bank. It invited SIAPS and EDTCP to provide technical and financial support for the PV agenda for Africa. Uppsala Monitoring Centre The Uppsala Monitoring Centre could not be present at the meeting. In a written message read to participants, the Director of the Uppsala Monitoring Centre (UMC) stressed that successful PV rises from strategic and sustainable programs that are thoroughly planned and based on a viable infrastructure of funding, people, and regulatory systems. The UMC called for “serious and open dialogue between all stakeholders” to constructively work together to fill the gaps and build systems for the future. The secret of success according to the UMC is to build on existing tools and resources and implement new developments step by step in a carefully planned and managed process and called for collaboration and dedication to the cause of protecting patients from harm. Discussion on PV Agenda for Africa and the Role of Partners Questions raised during this session related to the funding of RCOREs — were they funded by national governments? How will the PV-RCOREs effectively collaborate with regional economic blocs? Currently, none of the RCOREs receives funding for its activities from its own national government or a technical agency. While governments have been encouraged to support PV in their countries, it is obvious that the work of RCOREs requires further support from multilateral and bilateral agencies and international partners. Such funding should be stable and long term to ensure sustainability of the PV efforts. There was a call for establishing an African committee of PV experts to deliberate on African-specific issues in medicine and vaccine safety. Participants also called for establishing a database of experts in Africa and mapping all ongoing PV activities so that collaborations could be fostered and duplication reduced. PV-RCOREs Presentations A presentation was given on the Kenya PPB PV-RCORE’s on-going capacity-building efforts, planned activities, governance structure and linkages. Some of the key points highlighted included:

• The existence of an E-2B (the international standard for the transmittal of electronic safety data) compliant PV electronic reporting tool for submission of suspected adverse drug reactions and poor-quality medicinal products to the WHO, international agencies and the pharmaceutical industry. This has enhanced reporting.

• Short courses on PV and a MSc in pharmaco-epidemiology/PV at UON

• Kenya PPB has planned to launch short courses for QPPVs


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• The PV governance structures of PPB and UON are anchored within the PPB governance structure/organogram. It has strong linkages with MOH, PHP, KEMSA, counties, health facilities, and the public.

WHO-CC PV-RCORE highlighted its capacity building initiatives, which included—

• Providing support to countries to build PV capacity which involves in-country visits, training, and advocacy to Ministers of Health and donors. Country visits are undertaken following requests by countries who outline their needs and the areas in which they require support. Since 2009, nearly 30 African countries have been visited by the WHO-CC.

• The semi-annual four-week PV Fellowship program in Accra for PV workers

• The upcoming QPPV course and Vaccine Pharmacovigilance Fellowship programs

• The agreement between the WHO-CC and School of Public Health, University of Ghana, to organize a modular “Professional PhD in Pharmacovigilance” beginning 2016–2017 academic year subject to funding and formal approval by authorities at the University of Ghana

The WHO-CC RCORE highlighted the fact that funding remained a challenge, which required urgent consideration. With the provision of the appropriate level of long-term support, the PV-RCOREs will deliver for Africa and the world. This session was followed by a discussion among participants including the legal provisions for having QPPVs and the sustainability of QPPV trainings, the challenges encountered when incorporating PV in the curriculum at the universities, and, the concept for patient reporting and how it could be rolled out across the continent. Governance Structure and Linkages of the PV-RCOREs One of the specific objectives of the PV-RCOREs meeting was to discuss and agree upon the governance structures within and among the two RCOREs. This was preceded by a presentation by the AMRH (continued on day 2 of the meeting) on the governance structures under which all NEPAD Agencies operate and how these relate to overall governance at the African Union as agreed on by the Heads of State. Following this discussion, a breakout session was held during which the WHO-CC RCORE and its consortium partners deliberated on their governance while the PPB discussed its own governance issues. Partners were encouraged to move between the two groups so as to help shape approaches toward developing effective governance structures for the PV-RCOREs. The two PV-RCOREs were also encouraged to spend time to work out the optimum model for collaborating with each other. The RCOREs presented the outcome of their break-out sessions in plenary involving all meeting participants. WHO-CC PV-RCORE The WHO-CC consortium pointed out that it will have a steering committee with a Chairperson, Deputy Chairperson and Rapporteur. The Chair position will be rotational with a one-year tenure renewable up to a maximum of three years. The consortium will meet via


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conference calls quarterly, have annual face-to-face meetings, and may have additional meetings when desirable. In working closely with the PPB, the WHO-CC proposed inviting the PPB to its annual face-to-face WHO-CC RCOREs steering committee meetings as observers.

WHO-CC consortium and partners (left) and PPB and partners (right) discussing the above topic during a break-out session Pharmacy and Poisons Board (PPB) Kenya, PV-RCORE The PPB PV-RCORE group noted that they partner with the UON, public health programs in Kenya and with the Ministry of Health. The PPB has been in the process of signing an MOU with the UON whose focus is on training as well as calling on donors and partners with interest in PV via a stakeholders’ forum. It plans to share its work plan with NEPAD by July 2015. PPB PV-RCORE proposed establishing an MOU with WHO-CC consortium, identify areas to collaborate and leverage each other’s strength, share information and partner on training activities, undertake collaborative research, jointly develop tools, and set up registries. The linkage between the PPB PV-RCORE and the AMRH were also highlighted. These presentations were followed by a general discussion among the RCOREs and the partners which included the issues of

• The need to clarify and formalize the relationship between the PV-RCOREs and the regional economic blocs (EAC, ECOWAS/WAHO; SADC etc.)

• The invitation of partners, technical agencies and donors to meetings of the RCOREs governance teams

• Setting up a framework for engaging with the pharmaceutical industry in a way that will prevent real or perceived conflicts of interest.

The RCOREs were encouraged to share and communicate the impact of their efforts as it might help get some political and financial support for PV on the continent.

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ACCRA MEETING PROCEEDINGS—DAY 2

After a presentation by the East African Community (EAC) on their activities, broader discussions on capacity building, resource mobilization, and what the PV vision for Africa were held. These focused on how these efforts can be realized with the involvement of all stakeholders. Harmonization of PV activities in EAC Partner States The EAC is made up of the six partner states including Burundi, Kenya, Rwanda, Tanzania, Uganda and Zanzibar. All these partner states have NMRAs with basic structures for coordination of PV and PMS activities although the maturities of the systems are at different levels. Four out of six NMRAs are full members of the WHO Program for International Drug Monitoring, and Zanzibar and Burundi are associate members of the program. The EAC faces challenges in areas such as signal detection and data management, risk management, and communication, PV in public health programs and inadequate support from the industry to strengthen PV systems. The draft report of the situational analysis of PMS activities in the EAC was made available at the end of March for consultation and with funding from the Multi-Donor Trust Fund through the World Bank. The EAC PV Harmonization initiative plans to roll out its detailed plan of work immediately. Building Capacity for PV in Africa The Kenya PPB and WHO-CC chaired this plenary session. It is obvious that there is an urgent need to build PV capacity in Africa using multiple approaches. SIAPS gave a comprehensive presentation on capacity building using a tested and validated framework that looks at people and processes and is based on the regulatory framework existing in countries, the priorities of countries, individual and institutional capacities as well as available resources. USAID/SIAPS made participants aware of its interest in supporting both the PV-RCOREs as well as individual countries technically in this important area. In the area of building capacity for PV, participants agreed on the facts as currently exists: that is, currently only few countries teach PV in pre-service training institutions and most countries in Africa are resource constrained and several have weak health systems. It was therefore reiterated that the PV agenda must be pushed on the continent through the RCOREs but within a transparent and mature governance structure to ensure sustainability and to obtain buy-in from external partners. There should also be a platform that African regulators can use for the discussion of issues relating to PV. It was advocated that each regional economic community should have an expert working group (EWG) on PV with representations from member countries. Furthermore, there is the need to harmonize and streamline PV activities on the continent and use existing structures to achieve this. EWGs could invite members of the RCOREs either as full members or as observers.


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Work Plan Development and Funding for PV-RCOREs In view of the fact that both PV-RCOREs have submitted costed work plans to the AMRH, it was considered unnecessary to go into break-out sessions to discuss work plans. Rather, a general discussion was held to clarify the operationalization of PV-RCOREs within the context of the PV agenda for Africa. The discussions also included possible funding for PV-RCOREs. The following were the key issues that came out of this marathon group discussion involving the PV-RCOREs, technical partners and funding agencies: Pan African Technical Working Group on PV Participants agreed that an African Technical Working Group on PV should be established comprising members from the regional expert working groups as well as the PV-RCOREs. The AMRH was seen as the natural convener of such a group and was selected to take this proposal forward and set up the group once it was discussed with key African Union and NEPAD agency departments to ensure that the appropriate legislative processes are followed. PV Vision for Africa The PV Vision for Africa was extensively debated and two key considerations were noted—

• The need to ensure at least minimal capacity for every country in Africa by working to ensure that the 22 countries on the continent who are not full members of the WHO Program for International Drug Monitoring fulfill at least the minimum criteria for full membership as soon as possible.

• The need for focused PV activities in countries based on country/sub-regional priorities and in discussion with funding agencies

All participants also agreed that the vision for PV in Africa should contain the following—

• All countries should have national PV systems working with the WHO Program for International Drug Monitoring

• All products for public health programs including vaccines, anti-malarials, anti-TB drugs and anti-retrovirals should have a strong PV component

• Africa should have the human and technical capacity for PV; tools, methods, and resources for PV in Africa should be shared among countries

• PV guidelines, tools and approaches should be simplified and harmonized

• A database of PV experts should be established

• A web-based PV indicator tracking system should be established to monitor status/performance of country PV systems

• PV systems in all African countries should be sustainable and should involve collaboration with all stakeholders


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• World Bank funding for PV activities in the EAC is set to proceed while other partners, including SIAPS, are exploring possibilities of undertaking various specified activities in PV

Harmonization of PV requirements on the Continent The PV requirements on marketing authorization holders are harmonized globally as nearly all countries follow ICH guidelines with modest modifications to suit local conditions. The PV-RCOREs were tasked to harmonize PV guidelines and requirements on the continent to ensure their availability and that they are well publicized in Africa. Such guidelines should take into consideration African-specific requirements. All marketing authorization holders are encouraged to support and follow these guidelines Funding of PV-RCOREs No dedicated funding was offered during this discussion. However, the PV-RCOREs were encouraged to carry out appropriate advocacy activities and make a business case to donors for funding. The AMRH was requested to lead in sourcing funds for the operations of the governance systems in each RCORE. The need for unrestricted grants to support capacity-building, training and recurrent expenditure of each PV-RCORE was repeatedly mentioned as the sustainability of PV RCOREs without funds for these activities would be greatly jeopardized. Activity-based funding limits the ability of the RCOREs to carry out important activities like staff training, recruitment and retention of new staff as well as promotion and marketing of the activities of RCOREs as part of resource mobilization. Tools and Method Development The PV-RCOREs agreed to work with WHO, USAID/SIAPS and other partners including the UMC to develop, test and deploy specific tools for PV. Such tools, once validated could be shared continent-wide. PV-RCOREs were asked to identify best practices and disseminate them widely. Closing The AMRH thanked participants for the active roles they played throughout the meeting and noted the interest and enthusiasm of the two Africa PV-RCOREs to work together in all areas. The AMRH therefore called on partners to support the PV-RCOREs to achieve their mandate. The need for sustainability, regular evaluation and continuous engagement of governments and all stakeholders were all highlighted. Finally, the AMRH called for all participants to be fully involved on the next steps that would be taken following this meeting.

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RECOMMENDATIONS

Participants agreed on the following recommendations. Lead agencies/organizations are put in brackets after each recommendation.

• Ensure that all countries in Africa have a national PV system that works with the WHO Program for International Drug Monitoring (WHO, AMRH, PV-RCORES, SIAPS)

• Harmonize PV guidelines and requirements on the continent to ensure the availability simplified and well publicized guidelines for use by national regulatory agencies marketing authorisation holders and all other stakeholders in PV in Africa (PV-RCORES, AMRH)

• Establish clear metrics for assessing RCORE performance (AMRH upon discussion with PV-RCORES)

• Use existing tools including IPAT and the WHO PV Indicators to assess national PV centers (PV-RCOREs, SIAPS, WHO, UMC)

• Harmonize tools and indicators used for in Africa (PV-RCOREs, AMRH)

• Map all ongoing PV activities and tools in Africa to foster collaboration and reduce duplications (PPB, WHO-CC, AMRH)

• Establish a database of PV experts in Africa (AMRH, WHO-CC Africa)

• Establish an African Technical Working Group on PV comprising members from the regional Expert Working Groups as well as the PV-RCOREs (AMRH)

• Establish an expert working group within each regional economic community (EWG) on PV with representations from member countries (AMRH, Regional Economic Communities)

• Formalize the relationship between PV-RCOREs and regional economic blocs, e.g., EAC, ECOWAS (AMRH, EAC, WAHO)

• Development and dissemination of transparent and mature governance structures to drive the PV agenda for Africa whilst ensuring sustainability of PV-RCOREs and obtaining buy-in from external partners (PV-RCOREs, AMRH)

• Development, field-testing and deployment of tools for PV in Africa (USAID/SIAPS, UMC)

• Development of capacity for risk management and communication in all national PV centers (AMRH; PV-RCOREs)


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• Open flow of information from countries and partners to avoid duplication and contradictions (all)

• Serious and open dialogue between all stakeholders to constructively work together to fill the gaps and build PV systems for the future in Africa (AMRH, WHO, SIAPS, UMC, World Bank)

• Support from multilateral and bilateral agencies as well as international partners to complement the investments of individual governments in PV (World Bank, AMRH, WHO, SIAPS)

• Financial and technical resource mobilization for PV-RCOREs (AMRH) sourcing funds for the operation of the governance systems in each RCORE (AMRH)

Next Steps Participants agreed on the following next steps with the AMRH and PV-RCOREs taking lead in ensuring their progress and completion, and partners supporting as appropriate.

• Agreement and clear specification of the governance structure of each RCORE and the role of each partner

• Agreement and dissemination of the PV Vision for Africa and what it seeks to achieve in the short, medium and long term

• Mapping of the existing PV infrastructure in Africa including the trained personnel, training facilities and institutions, tools, methods and expertise

• Agreement of the core content of the core curriculum for PV personnel in Africa ensuring it also includes the required body of knowledge specified by the AMRH

• Development of an advocacy and resource mobilization strategy by each RCORE

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ANNEX A. LIST OF ATTENDEES

Name Organization Alex Nkayamba Tanzania Food and Drug Authority Alexander Dodoo WHO-CC Ghana Ali Ibrahim National Agency for Food and Drug Administration and Control Andreas Seiter World Bank Deirdre McCarthy Quintiles Inc. Delese (Mimi) Darko Food and Drugs Authority Ghana Edward Abwao Pharmacy and Poisons Board Kenya Evi Bedel USAID/SIAPS Faith Okalebo University of Nairobi Francis Aboagye-Nyame USAID/SIAPS Francis Aduteye MSH/Ghana Fred Siyoi Pharmacy and Poisons Board Kenya George Sabblah Food and Drugs Authority Ghana Gladys Tetteh MSH/Ghana Hilda Haggar Ampadu WHO-CC Ghana Hudu Mogtari Food and Drugs Authority Ghana Irene Frempong Food and Drugs Authority Ghana Jean Marie Habarugira European and Developing Countries Clinical Trials Partnership John Patrick Mwesigye East African Community Joseph Adu USAID/SIAPS Josephine Gyawu U.S. Agency for International Development Katelyn Payne USAID/SIAPS Margareth Ndomondo-Sigonda NEPAD Melissa Thumm USAID/SIAPS Ndinda Kusu USAID/SIAPS Paul Tanui NEPAD Shanthi Narayan Pal World Health Organization Star Khoza Medicines Control Authority of Zimbabwe Xavier Crespin West African Health Organization

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ANNEX B: AGENDA

14 May 2015 | Day One Time Activity Speakers

08:30 – 09:00 Arrival & Registration

09:00 – 09:15 Welcome & Introductions A. Dodoo, WHO-CC

SESSION I Introduction and Purpose of the PhV RCOREs Chair: M. Ndomondo-Sigonda, NEPAD Agency

09:15 – 09:30 Adoption of the Draft Program NEPAD Agency

09:30 – 10:30 Remarks by NEPAD AMRH Program Partners (5 minutes per speaker)

NEPAD Agency WHO-HQ World Bank USAID USAID/SIAPS WAHO EAC Ghana FDA

10:30 – 10:45 Objectives of the meeting and expected outputs

A. Dodoo, WHO-CC and F. Siyoi, PPB

10:45 – 11:15 Purpose and role of the PhV RCOREs NEPAD Agency

11:15 – 11:45 Tea/Coffee Break & Group Photo All

SESSION II Africa’s PV Agenda Chair: M. Darko, Ghana Food and Drugs Authority

11:45 – 12:30 The PV Agenda for Africa and the Role of Partners: The PhV Agenda in Africa WHO’s Capacity Building in Africa 2005-2015 PhV in Public Health Programs EAC PV Project Role of Partners (15 minutes per speaker)

NEPAD WHO-HQ USAID/SIAPS World Bank EAC WAHO

12:30 – 13:00 Discussion on the PV Agenda for Africa and the Role of Partners

All

13:00 – 14:00 Lunch Break All

SESSION III Updates and Proposed Governance Structures for the PhV RCOREs Chair: F. Aboagye-Nyame, USAID/SIAPS

14:00 – 15:00 Presentations from the PhV RCOREs Structure and Capacity Building Initiatives Funding for PhV RCOREs

WHO-Collaborating Centre for Pharmacovigilance and Partners Pharmacy and Poisons Board and University of Nairobi

Agenda

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Time Activity Speakers

15:00– 16:00 Proposed Governance Structure and Linkages PhV RCOREs and consortium partners PPB and WHO-CC consortium NEPAD AMRH and PhV RCOREs (Group discussions)

Group 1: WHO-Collaborating Centre for Pharmacovigilance, WAHO and Partners Group 2: Pharmacy and Poisons Board Kenya, EAC and Partners

16:00 – 16:15 Tea/Coffee Break All

16:15 – 16:30 Continuation of Group Discussions on Proposed Governance Structure and Linkages

Groups

16:30 – 16:45 Plenary Presentations All

16:45 – 17:00 Wrap-up & End of Day One A. Seiter, World Bank

18:00 Depart for Networking Cocktail Transportation provided by Novotel

18:30 – 20:30 Networking Cocktail and Launching of African Society of Pharmacovigilance 2015 Conference

Location: WHO-CC, One MedSpina Place, Mango Tree Avenue, Asylum Down

20:30 Return to Hotel Novotel Accra City Centre Transportation provided by Novotel

15 May 2015 | Day Two Time Activity Speakers

09:00 – 9:15 Recap & Review of Day One A. Ibrahim, NAFDAC

SESSION IV Capacity Building and Work planning for the PhV RCOREs Chairs: A. Dodoo, WHO-CC Ghana and F. Siyoi, PPB Kenya

09:15 – 10:30 Building Capacity for PV in Africa Capacity Building Approaches Areas of Focus and Need Resource Mobilization

NEPAD WHO USAID/SIAPS

10:30 – 11:00 Tea/Coffee Break All

11:00 – 13:00 Discussion on Building Capacity for PV in Africa (continued)

All

13:00 – 14:00 Lunch Break All

14:00 – 14:45 2015/2016 Workplans for PhV RCOREs Groups

14:45 – 15:30 Plenary Presentations All

15:30 – 16:15 Next Steps & Closing Remarks NEPAD Agency

16:15 – 16:45 Tea/Coffee Break and Departure All

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ANNEX C: CONCEPT NOTE

Concept note for the Meeting of Regional Centres of Regulatory Excellence (RCOREs) in Pharmacovigilance, NEPAD Agency AMRH Programme and USAID/SIAPS, 14-15 May 2015, Accra, Ghana

1. Background Promoting best practice in pharmacovigilance (PhV) is increasingly becoming crucial to ensure medicines safety and protection of public health. Adverse drug events (ADEs) from poor product quality, adverse drug reactions (ADRs), and medication errors contribute significantly to morbidity and mortality in developing countries. The lack of relevant policy and regulations in Sub-Saharan Africa (SSA) reflects fundamental limitations for enforcing medicine safety monitoring1. Of the 46 SSA countries, 74 percent have a PhV center or unit with a clear mandate and formal organizational structure, 39 percent have national PhV guidelines, 39 percent have a safety advisory committee, and 45 percent have a drug information service. However, country coordination of all stakeholders is minimal - only 28 percent have a platform or strategy to coordinate PhV activities at the national level. An analysis of pharmacovigilance activities in 55 low and middle-income countries2 conducted in collaboration with the World Health Organization showed several challenges in implementing PhV in LMIC the major challenges being lack of training and stable funding. According to Management Sciences for Health 20123, poor product quality, adverse drug reactions (ADRs), and medication errors greatly influence health care systems by negatively affecting patient care and increasing costs. Most of the statistics documenting these issues and highlighting the importance of pharmacovigilance come from developed countries, therefore low-and middle-income countries likely have greater problems because of the poorer state of their health system infrastructure, the unreliable supply and quality of medicines, the lack of adequately trained health care staff, and their limited access to communication and information technology. WHO through its Medicines Safety Programme and its Collaborating Centres in Pharmacovigilance has played an important role in setting the norms and standards in the field of pharmacovigilance and in capacity building especially in Africa where the specific

1 Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance (SPS,2011) 2 Olsson S1, Pal SN, Stergachis A, Couper M. Pharmacovigilance activities in 55 low- and middle-income countries: a questionnaire-based analysis. Drug Saf. 2010 Aug 1;33(8):689-703 3 MDS-3: Managing Access to Medicines and other Health Technologies(MSH, 2012)

Concept Note

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features of the existing pharmacovigilance infrastructure have been well described4. Aware of the challenges in collecting safety data in Africa and other low and middle-income countries, the WHO has based its PhV strategy on public health programmes and published its strategy for collecting safety data in these programmes. This provides a good platform for PhV development in Africa. The Accra meeting is being held as a follow-up from the side meeting held on 19th February, 2015 in Cape Town between the NEPAD designated Regional Centres of Regulatory Excellence (RCOREs) in Pharmacovigilance and USAID-SIAPS Program during the consultation meeting of RCORES and potential funding agencies. The participants were drawn from NEPAD Agency, USAID-SIAPS, the Ghana WHO Collaborating Centre and its consortium institutions. The meeting discussed potential areas of collaboration including: enhancing networking between the PhV-RCORES, especially between the Kenya PPB and Accra WHO-CC PhV Consortium; ensuring synergies between the activities of the PPB, WHO-CC and EAC; development of PhV Training of Trainers (ToTs); collaboration for country support; PhV Consultants Network; PhV Information system and customization and validation of the Indicator-based Pharmacovigilance Assessment Tool (IPAT) as well as the WHO PhV Indicators for the AMRH Initiative. The NEPAD Planning and Coordinating Agency in 2014 designated 10 institutions and/or partnership of institutions as RCOREs as indicated in Annex II. The designated institutions will play a crucial role in regulatory capacity development in Africa. This entail their participation in the production of regulatory workforce for Africa through provision of academic and technical training in regulatory science applicable to different regulatory functions and managerial aspects; skills enhancement through hands-on training, twinning and exchange programmes among National Medicines Regulatory Authorities (NMRAs); and practical training through placement in pharmaceutical industry and/or NMRAs. The RCOREs initiative was developed by the African Medicines Regulatory Harmonization (AMRH) Programme through a series of consultations with key stakeholders and experts in regulatory capacity building. This culminated in the publication of a call for expression of interest for institutions interested to be selected as RCOREs in October 2013 and a selection process based on pre-determined eligibility criteria that designated the 10 RCOREs in May 2014. The RCOREs have been categorized according to their areas of expertise and strength in training and/or service delivery in different regulatory functions.

• Assessing the safety, efficacy and quality of medicines, and issuing marketing authorization;

• Clinical trials oversight;

• Licensing of the manufacture, import, export, distribution, promotion and advertising of medicines;

4 Isah AO, Pal SN, Olsson S, Dodoo A, Bencheikh RS. Specific features of medicines safety and pharmacovigilance in Africa. Ther Adv Drug Saf. 2012 Feb;3(1):25-34.


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• Pharmacovigilance and Pharmacoepidemiology;

• Inspecting and surveillance of manufacturers, importers, wholesalers and dispensers of medicines;

• Providing independent information on medicines to professionals and the public; and

• Quality Assurance and Quality Control of medicines and medical devices

Two RCOREs have been designated as RCOREs in Pharmacovigilance namely:

• WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance; University of Ghana Medical School

• Pharmacy and Poisons Board, Kenya

Harmonizing pharmacovigilance systems is currently an evolving phase of the African Medicines Regulatory Harmonization (AMRH) Programme. By design the AMRH Initiative works through Regional Economic Communities (RECs) to advance the harmonization of requirements for approval of medicines. The initial phase of the programme focused on harmonizing requirements for medicines registration. There is increasing demand by RECs and countries to identify and promote harmonization activities for clinical trials oversight as well as pharmacovigilance. Several RECs such as the East African Community (EAC) have initiated activities towards achieving these aspirations.

2. Objectives of the meeting

The main objective of the Accra meeting is to align the efforts of the two RCORES in PhV (Pharmacy and Poison Board of Kenya and the WHO Collaborating Centre for Pharmacovigilance and its consortium of partners) with the work that is currently being undertaken by WHO, UMC, USAID/SIAPS and other partners in the African region. It will further seek to ascertain the objectives of the RCOREs in PhV under the AMRH initiative and to bring all capacity building efforts together to avoid duplication and improve synergies among technical partners and national authorities. Specific objectives of the meeting are to:

• Review on-going regulatory capacity building activities in PhV RCOREs and mobilize partners in their support

• Agree on a continental framework for governance and coordination of pharmacovigilance activities in Africa

• Review development of curriculum and TOTs as part of building capacity for pharmacovigilance in Africa

• Develop 2015/2016 Workplan for PhV RCOREs

Concept Note

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3. Expected Outputs The expected outputs from the meeting are:

• The Pharmacovigilance agenda for Africa and the role of partners reviewed • Capacity building in PhV carried out by PhV RCOREs and partners reviewed • Governance Structure and linkages for pharmacovigilance in Africa agreed • 2015/2016 Workplan for PhV RCOREs developed

4. Participants

Participants in the meeting will include PhV RCOREs (WHO-CC in PhV and consortium partners-Quintiles, MCAZ, TFDA, Ghana FDA, NAFDAC; PPB Kenya & University of Nairobi), NEPAD Agency, Ghana FDA, USAID, USAID/SIAPS, USFDA, AMRH Programme Partners, WHO, UMC World Bank, EDCTP, EAC, WAHO and other funding, implementing and technical support agencies.

5. Meeting Process & Agenda The discussions of meeting will be guided by the following agenda:

1) Welcome and Introductions

2) Adoption of the Draft Agenda and Programme

3) Remarks by NEPAD Agency, AMRH Partners, WHO and other technical

partners

4) Objectives of the Meeting

5) Role of PhV RCOREs

6) The Pharmacovigilance agenda for Africa and the role of partners

7) Updates from the PhV RCORES

8) Proposed Governance Structure and linkages

9) Building Capacity for Pharmacovigilance in Africa

10) 2015/2016 Workplan for PhV RCOREs

11) Close of meeting

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ANNEX D: NEPAD Agency Designated Regional Centres of Regulatory Excellence (RCORES)

May 2014

1. WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance; University of Ghana Medical School (RCORE in Pharmacovigilance)

2. Kilimanjaro School of Pharmacy; St. Luke’s Foundation Tanzania (RCORE in training in core regulatory functions)

3. WHO Collaborating Centre for the Quality Assurance of Medicines NWU - Potchefstroom Campus South Africa (RCORE in Quality Assurance and Quality Control of medicines)

4. Centre for Drug Discovery, Development & Production University of Ibadan Nigeria (RCORE in training in core regulatory functions)

5. Medicines Control Authority of Zimbabwe (MCAZ) (RCORE in medicine registration and evaluation, Quality Assurance/Quality Control and clinical trials oversight)

6. National Drug Authority (NDA), Uganda (RCORE in licensing of the manufacture, import, export, distribution and; inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicines)

7. Direction General de la Pharmacie du Medicament et des Laboratoires / University of Ouagadougou Burkina Faso (RCORE in clinical trials oversight)

8. Food & Drugs Authority (FDA) Ghana (RCORE in medicine evaluation and registration and clinical trials oversight)

9. Pharmacy & Poisons Board (PPB) Kenya (RCORE in pharmacovigilance) 10. Tanzania Food & Drugs Authority (TFDA) / School of Pharmacy Muhimbili

University of Health and Allied Sciences (MUHAS) (RCORE in medicine evaluation and registration)

meeting of regional centres of regulatory excellence (rcores) in

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