SAPRAA 2010 Presentations

November 2010

ACTIVATE and ENERGISE your best you! (2.11 MB PPT)

Biosimilars Guideline – a Summary of the Industry Commenta (1.18 MB PPT)

ZA CTD (672 KB ZIP)

SA Code of Practice for the Marketing of Health Products(1.35 MB PPT)

September 2010

CTD/eCTD guidelines PIASA’S comments (105 KB PDF)

SAPRAA Agenda (25 KB PDF)

Regulatory requirements for the ZA CTD (299 KB Word)

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Regulatory Requirements for the ZA CTD (123 KB PDF)

Comprehensive table of Contents(44 KB PDF)

Dossier product batch information(14 KB PDF)

Dossier batch Information (23 KB PDF)

Screening and Technical Verification Template(83 KB PDF)

The ZA CTD(3.22 MB PDF)

Preparing for the CTD (and more)- Michael S. Schultz (411 KB PDF)

June 2010

Feedback on MCC Project meeting held on 14 May 2010 213 KB PPT)

Ethics and Compliance (2.19 MB PPT)

Draft SA Marketing Code (1.61 MB PPT)

March 2010

Financial Statements (33.7 KB PDF)

SAPRAA Activities 2009 (541 KB PDF)

eCTD: Industry Experience (323 KB PDF)

2nd African Regulatory Conference:KEY TAKEAWAYS (2.15 MB PDF)

Malaria (2.03 MB PDF)

The ideal clinical submission (109 KB PDF)

Stability testing conditions of pharmaceuticals (3 MB PDF)

				2019