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.
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.