MCC Structure
MRA Structure
MRA Contact Details
Documents under section:
Workshops and Conferences
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What are biotechnology products – Crommelin (zipped PDF 1548Kb)
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Prerequisites for safe and efficacious biological medicinal products, with special reference to “biosimilar” products – Holloway (zipped PDF 338Kb)
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Immunogenicity of biopharmaceuticals – Schellekens et al (zipped PDF 160Kb)
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MCC/Industry Workshop Presentation By Clinical Trials 03 November 2009 (MS PowerPoint 482KB)
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MCC/Industry Workshop Presentation By Medicines Evaluation and Research (Pre-Reg) – 03 November 2009 (MS PowerPoint 152KB)
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MCC/Industry Workshop Presentation By Medicines Evaluation and Research (Post-Reg) – 03 November 2009 (MS PowerPoint 128KB)
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Issues related to the formulation and delivery of pharmaceutical proteins – Crommelin (zipped PDF 896Kb)
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Regulatory issues and drug product approval for biopharmaceuticals – Shah (zipped PDF 32Kb)
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Clinical trials for biotechnology medicines – Southern (zipped PDF 20Kb)
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Regulatory testing of biological medicines – Vergeer (zipped PDF 468Kb)
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Biotech 2007 Summary – Hela (zipped PDF 48Kb)
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Biologicals,Biosimilars: A South African Perspective of Registration – Mbelle (zipped PDF 79Kb)
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Assessing similarity of biosimilars to innovator biopharmaceuticals: A reviewer”s perspective – Leng (zipped PDF 561Kb)
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SADC HARMONISATION INITIATIVES – ICH MAY 2007 (MS-Powerpoint 77Kb)
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MCC/Industry Workshop Presentation By Operations and Administration – 03 November 2009 (MS PowerPoint 1.7MB)
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MCC/Industry Workshop Presentation By Clinical Evaluations Unit – 03 November 2009 (Zipped MS PowerPoint 1.4MB)
