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Pharmaconnect Conference 2019

Pharmaconnect 2019

Reliance and Worksharing – lessons for Africa

About the Conference

The theme for the main conference (3 – 4 April 2019) is Reliance and Worksharing – lessons for Africa. The conference will discuss how reliance and work sharing models can be developed for use in general but with a particular focus on biological and biosimilar medicines.


The WHO has recognized the need for regulatory collaboration (often called reliance) in order to avoid duplication of work among regulators and thus ensure timely patient access to safe and effective therapeutic products. Reliance results in reducing the workload of regulators leading to more efficient use of limited resources to address greater complexity of issues in medicine regulation. Reliance may be achieved by information and/or work-sharing and mutual recognition of assessment and inspection results through a variety of mutual recognition agreements and national legislation.
Increasingly African regulators are taking up reliance and work sharing models especially with regards to the assessment of complex medicines, such as biological and biosimilar medicines where they have little capacity and technical expertise. PharmaConnect Africa 2019 will tackle the issue of reliance and work sharing in Africa giving both industry and regulatory perspectives.

Medicinal Cannabis

About the Symposium

This year the symposium to be held in April 2019 will address the topic Developing the Medical Cannabis Industry in Africa.

There is a buzz about medical cannabis which is sweeping across (Southern) Africa, as elsewhere in Western Europe and North America. The marijuana plant contains more than 100 cannabinoids. Each one has a different effect on the body. Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are the main chemicals used in medicine.

Medicinal cannabis, or medicinal marijuana, is an emerging promising global industry but with still many legal, ethical, and societal controversies. The growing, therapeutic use, safe administration, and adverse health consequences all represent some of the complexities associated with this treatment.

The emergence of interest in botanical medicinal cannabis is an opportunity for African countries to turn this into a legitimate and well-regulated forex earner. To do this there is a need to build capacity from farm to bedside. The symposium will be an opportunity to hear from regulators, legal, agriculture, pharmaceutical and medical experts on how to build and sustain a medical cannabis industry in Africa.
The conference and symposium will follow a roundtable format with plenary speakers and discussants for each of the thematic area, followed by Q&A sessions. We have found that this engenders important dialogue.

Day 1

Please click on the Presentation to download the speaker’s presentation.

Day 3

Please click on the Presentation to download the speaker’s presentation.

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Pharmaconnect 2018

Pharmaconnect 2018

Before and Beyond Registration

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

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.

 

Presentation Downloads

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Pharmaconnect 2017

Pharmaconnect 2017

Access to Essential Medicines for Africa

The inaugural Pharmaconnect Africa Conference and Expo were held on the 29th and 30th of March 2017. In 2017, there was official representation from regulators (Ghana FDA, East Africa Community (EAC) and Medicines Control Council (MCC)), Department of Health (South Africa), local manufacturers (NAPM and SAGMA), innovator companies and associations under the auspices of Innovative Pharmaceutical Association of South Africa (IPASA), various South African universities, UN agencies (UNIDO and WHO), and SADC-aligned business forum (SABF). The attendance averaged 110 participants per day and participants were drawn from the whole value chain of pharmaceutical providers.

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.

Access to Essential Medicines for Africa

Themes & Topics

Clinical trials in Africa – towards priority reviews for essential medicines

Some regulators have started to give priority reviews to essential medicines in registration. However, this is not matched with priority approval of clinical trials. How can the priority approval system be implemented and what resources are needed to improve efficiencies in the overall handling and approval of clinical trials?

Harmonization or convergence?​

Harmonization has long been talked about, but little progress seems to have been made in Africa because of factors including variable geometry, national sovereignty, and language. Increasingly there is a focus on convergence as an easier first step towards regional harmonization. What are the quick wins in this area? Should consideration be given to harmonization or convergence which goes beyond medicine regulation to clinical guidelines? What opportunities are available to industry for collaborations in harmonization and convergence?

Education and training

There is a very little emphasis in the current pharmacy curricula in pharmaceutical logistics, supply chain management and the attendant regulatory framework and quality management systems. Can short training programmes be developed and how can they be quickly accredited? What are the opportunities for collaboration between universities and private training institutions in the education and training arena to build capacity on the Africa continent?

Local manufacturing for local needs

There has been de-industrialization in many African countries with global pharmaceutical companies retreating to global centres of excellence along with the entry of Indian – manufactured products. This may result in severe supply shocks and stock-outs. How can local and global companies play a role in ensuring the security of supply of essential medicines?

 

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