African Regulatory Conference 2010
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African Regulatory Conference 2010 Florence Roizord EFPIA-International Regulatory Affairs Group Africa Regulatory Network Lead: Director, Regulatory Affairs. Middle East and Africa. Merck Sharp 0 Dohme. France Correspondence Address Florence Roizard (email: Florence-Roizard@merck. com).
The second Afican Regulatory Conference (ARC), which took place in Johannesburg on March 2-3,2010, was organized by the Drug Znformation Association (DlA) and cosponsored by the South Afican Development Community (SADC). The conference program was developed by the Africa Regulatory Network of the European Federation of Pharmaceutical Industries and
ARC 2010 was attended by more than 200 participants including around 40 African regulators, regulators from other regions, various organizations, and members of the pharmaceutical industry worldwide. The conference focused on access to safe, effective, and quality medicines in the African region, and provided the opportunity to: Openly discuss issues facing African regulatory authorities and industry. Share information and best practices, and identify potential workable solutions that meet the needs of the region. Foster collaboration between African regulators and the pharmaceutical industry.
Presentations were given by regional and international speakers.
INTRODUCTORY REMARKS In the introductory remarks, the conference chair, Professor Trevor Jones, CBE, Kings College London, UK, highlighted the significant changes in technologies within medical research, impacting the way medicines are regulated and assessed. Both industry and regulators own the responsibility to ensure patient access to new medicines in Africa, be it essential medicines or new entities. Pr. Jones emphasized the importance of shortening time to market availability of medicines as a critical part of enhancing access in Africa, and pointed out the need for data sharing to maximize the use of limited regulatory resources. One mechanism to
Associations (EFPlA) in cdlaboration with a team of program advisors, composed of regulatory authority representatives from several African countries (Ghana, South Africa, Uganda, Zimbabwe, and Zambia), of two industry association heads (Innovative Medicines South Africa and Pharmaceutical lndustry Association of South Africa), and a World Health Organization delegate.
reach this stage is harmonization, which was one of the key topics of the conference. Mr. Joseph Mthetwa, Senior Program Manager for Health and Pharmaceuticals, SADC Secretariat, Botswana, and conference cochair, commented on the SADC objectives applicable to its 15 member states, and called on participants to collaborate to secure reliable medicine supply systems, and improve regulatory mechanisms concerning registration as well as control of medicines, for the benefit of the African patient.
KEYNOTE ADDRESS In the keynote address, Ms. Mandisa Hela, Registrar, Medicines Regulatory Agency, South Africa, noting that the patient is central to both regulators and industry, urged exploration of new partnerships fo
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