SAPRAA 2012 Presentations


November 2012


eCTD


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


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


PPTCurrent Master outline (100.95 KB)


PPTSequence Master outline (108 KB)


PPTeCTD Next Major Release Business Requirements Collation (105 KB)


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


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





PPTForecasted guideline changes 2013 (596 KB)


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

 

OR


PPTSlides 1 - 4 (3.48 MB)


PPTSlides 5 - 6 (4.04 MB)


PPTSlides 7 - 10 (2.80 MB)


PPTSlides 11 - 16 (1.59 MB)


PPTSlides 17 - 22 (1.15 MB)


PPTSlides 23 - 30 (1.11 MB)


PPTSlides 31 - 37 (2.14 MB)


PPTSlides 38 - 41 (2.19 MB)


PPTSlides 42 - 45 (1.82 MB)


PPTSlides 46 - 49 (2.78 MB)


PPTSlides 50 - 56 (4.15 MB)


PPTSlides 57 - 62 (1.15 MB)


 

 

September 2012


PPTCAMS Update from HPA Perspective (3.10 MB)


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


PPTSA Marketing Code of Practice (152 KB)


June 2012



PPTAfrica Regulatory Conference Feedback (119 KB)


PPTMedicine Regulation Regulatory Departments GoodD Regulatory Practice (467 KB)


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


PPTM&L Disaster Recovery Experience (6.73 MB)


PPTTHE MCC - Today and the Future (76.4 KB)




March 2012


PDFARC Flyer (1.32 MB)


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


PPTSAPRAA Financial Report 2012 (1.024 MB)


PPTFeedback on Industry meeting with Nicholas Crisp (573 Kb)

 



MCC Presentation


WMV2.25_PA_CTD_Jun11_v3 (368 KB)


WMV5x5 (4.120 MB)


WordAmendment Submissions: Format (24 KB)


word3.2.R.1.4 Pharmaceutical availability studies (12.4 KB)


WMVCEPT as per guidelines (13 KB)


WordAPI report of Comparative study (12 KB)


WordMCC contact information (13.1 KB)


WordAPPENDIX A2 Example (15 KB)


WordAS Example Perfect Cure 500 mg (17 KB)


WordComprehensive table of contents (12 KB)


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


WordCover Letter Section 6 (13 KB)


WordCTD stability data (12 KB)


WordCTD vs MBR1 vs MRF1 (247 KB)


WordcTOC for MRF1 to CTD transition example (38 KB)


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


WordExample Pharmaceuticals Pty Ltd (68 KB)


WordEXAMPLE PHARMACEUTICALS cover page of submission (15 KB)


WordEXAMPLE PRODUCT, 12345 CTD update (14 KB)


WordPART B: MODULE 1 (14 KB)


PPTTabs used in CTD submissions (2.4 MB)


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


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


WordTOC working doc (32 KB)


WMVWinter (3.959 MB)


PPTZA CTD: 9 months later (395 KB)