SAPRAA 2012 Presentations

November 2012

eCTD

Update on Regulatory Developments around the eCTD in Europe and the Quantum Leap ahead for South Africa (911 KB)

Update on Regulatory Developments around the eCTD in Europe and the Quantum Leap ahead for South Africa (3.50 MB)

Current Master outline (100.95 KB)

Sequence Master outline (108 KB)

eCTD Next Major Release Business Requirements Collation (105 KB)

International Conference on Harmonisation of technical requirements for registration of Pharmaceuteicals for human use (191 KB)

Organisation of the common technical document for the regsitration of pharmaceuticals for human use M4 (245 KB)

Forecasted guideline changes 2013 (596 KB)

Pharmacodynamics & Pharmacokinetics:PI and PIL considerations (22.4 MB)

OR

Slides 1 - 4 (3.48 MB)

Slides 5 - 6 (4.04 MB)

Slides 7 - 10 (2.80 MB)

Slides 11 - 16 (1.59 MB)

Slides 17 - 22 (1.15 MB)

Slides 23 - 30 (1.11 MB)

Slides 31 - 37 (2.14 MB)

Slides 38 - 41 (2.19 MB)

Slides 42 - 45 (1.82 MB)

Slides 46 - 49 (2.78 MB)

Slides 50 - 56 (4.15 MB)

Slides 57 - 62 (1.15 MB)

September 2012

CAMS Update from HPA Perspective (3.10 MB)

Comparative Dissolution Requirements and Challenges to the Pharmaceutical Industry (1 MB)

SA Marketing Code of Practice (152 KB)

June 2012

Africa Regulatory Conference Feedback (119 KB)

Medicine RegulationRegulatory Departments GoodD Regulatory Practice (467 KB)

How can we Manage Performance in Regulatory Affairs? (2.86 MB)

M&L Disaster Recovery Experience (6.73 MB)

THE MCC - Today and the Future (76.4 KB)

March 2012

ARC Flyer (1.32 MB)

Medical Devices and Regulations: Feedback from SAMED's Meeting with Benguela EOH 27 February 2012 (315 KB)

SAPRAA Financial Report 2012 (1.024 MB)

Feedback on Industry meeting with Nicholas Crisp (573 Kb)

MCC Presentation

2.25_PA_CTD_Jun11_v3 (368 KB)

5x5 (4.120 MB)

Amendment Submissions: Format (24 KB)

3.2.R.1.4 Pharmaceutical availability studies (12.4 KB)

CEPT as per guidelines (13 KB)

API report of Comparative study (12 KB)

MCC contact information (13.1 KB)

APPENDIX A2 Example (15 KB)

AS Example Perfect Cure 500 mg (17 KB)

Comprehensive table of contents (12 KB)

P&A POST-REGISTRATION AMENDMENT - Deadline 12 March 2012 (15 KB)

Cover Letter Section 6 (13 KB)

CTD stability data (12 KB)

CTD vs MBR1 vs MRF1 (247 KB)

cTOC for MRF1 to CTD transition example (38 KB)

Example: APPLICATION FOR REGISTRATION OF A MEDICINE (147 KB)

Example Pharmaceuticals Pty Ltd (68 KB)

EXAMPLE PHARMACEUTICALS cover page of submission (15 KB)

EXAMPLE PRODUCT, 12345 CTD update (14 KB)

PART B: MODULE 1 (14 KB)

Tabs used in CTD submissions (2.4 MB)

PERFECT CURE 500 mg cTOC EXAMPLE PHARMACEUTICALS (PTY) LTD (36 KB)

Someone should tell this girl this can't be done (6.769 MB)

TOC working doc (32 KB)

Winter (3.959 MB)

ZA CTD: 9 months later (395 KB)

				2019