ABOUT THE CONFERENCE
Dates: 3 & 4 April 2019
Venue: GLENHOVE, JOHANNESBURG, SOUTH AFRICA
The theme for the conference (3 – 4 April 2019) is Reliance and Worksharing – lessons for Africa. The conference will discuss how reliance and worksharing 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 worksharing 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 worksharing in Africa giving both industry and regulators perspectives.
For more information, visit: http://pharmaconnect.co.za/