About the conference:
The World Health Organization (WHO) introduced the concept of essential medicines in 1977. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price, the individual and the community can afford. They are selected with due regard to public health relevance, evidence of efficacy and safety, and comparative cost-effectiveness. In Africa, many countries have adopted the Essential Medicines List concept and embraced the principles of rational use of medicines. However, there are critical challenges which this 2-day conference and exposition will seek to address. The areas of focus of PharmaConnect Africa (PharmaConnect-A 2017) will be local pharmaceutical manufacturing, offshore procurement and distribution, and the over-arching role of medicine regulation along the whole value chain. Discussions will cut across both human and animal health care in Africa.
PharmaConnect-A 2017 will bring together all strategic stakeholders from key regulatory authorities, local and transnational companies, academics and NGOs for discussions around their roles and responsibilities in affordable and efficient health care delivery in Africa with a specific focus on Essential Medicines.
Themes & Topics
The theme for the 2018 event is “Before and Beyond Registration”. In line with this theme we will have a dedicated session focussed on Clinical Trials (“the before”) and a second on Building Capacity for Pharmacovigilance (‘the after”). Another exciting feature this year is a half-day post-conference symposium jointly organized by USP, GSK and SAGMA. It is aimed primarily at information sharing on a chlorhexidine formulation – particular interest to local manufacturers in the region.
Clinical Trials in Africa – Opportunities and Challenges
Role of Clinical Research Organizations (CRO) and Product Development Partnerships (PDP)
There has been an increase in CROs and PDPs working across the continent. How has their work been facilitated/retarded, and do they enhance local healthcare systems? Is the value that they bring recognized by national governments, and does that outweigh perceived risks? What is the role of CROs and PDPs in the knowledge economy in Africa, and how can this be measured and enhanced? What is the role of civil society and patient groups in ensuring safer and ethical clinical trials in Africa?
Speakers – representatives of CROs & PDPs, civil society, government departments, regulatory authorities
Building the Capacity for Pharmacovigilance
Pharmacovigilance is increasingly becoming important. It ensures that medicines and vaccines are safe to use and that there is oversight from the regulator and manufacturers. This session will discuss what different roleplayers are doing to enhance pharmacovigilance globally and in Africa. It will touch on important lessons learnt and the gaps identified. Speakers – representatives from South African Health Products Regulatory Authority (SAHPRA), GSK (UK), Zazibona
Medical Device Regulation – Where are we and what to expect next? – SANAS / SAHPRA
Implementation of Sound Policies to Improve Access
Despite these high expenditures on medicines, access to essential medicines and products is still highly restricted. Low local manufacturing capacity leads to reliance on imported medicines. This often leads to non-availability of the commodity. In the public sector, across Africa, the availability of essential medicines has been reported to be less than 60% by the World Health Organisation (WHO). There is, thus, limited access to safe, effective, quality and affordable medicines, vaccines, and diagnostic tools. Key to addressing availability and access issues is the ability of key institutions in Africa which enhance the medicine supply value chain from imports of finished goods, or API, to manufacturing, distribution, regulation and good dispensing…and everything in between. To achieve optimal access, the continent needs to develop coherent policy frameworks in which all stakeholders – innovators, local manufacturers, regulators, government departments, NGOs and patient groups – are included. In this session, panellists will discuss existing strategies and discuss ways of enhancing these to create improved access.
Speakers – industry representatives (SAGMA, IPASA), academics, government agencies
Innovator – Local Manufacturer Partnerships
The collaboration of local producers with innovator companies is essential but it is not happening at visible scale. What are the barriers to collaboration and how can they be removed? What opportunities are presented by collaboration between would-be competitors? What benefits accrue to governments and patients when there is collaboration? What incentives are available to local producers and how can they be accessed? In this panel, GSK (UK) will discuss some strategies for possible hookups with local manufacturers around the manufacture of chlorhexidine for neonatal use.
Speakers – SAGMA, GSK (UK), USP, Department of Trade, Regulators.