Transcript No Slide Title

FEEDBACK ON MCC
PROJECT MEETING
HELD ON 14 MAY 2010
Dr Dorcas Peta
4 JUNE 2010
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Objectives of this Presentation
FEEDBACK ON THE FOLLOWING ISSUES:
 Project Management Team
 Backlog Project
 Communication with MRA
 Introduction to SAHPRA
 MRA and SAHPRA fee structure
 MRA communication with Industry
 SAHPRA communication with Industry
 Additional items raised
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Project Management Team (PMT)
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Dr Nicholas Crisp – Project Leader
Dr Johan van Heerden
Carol Fries
Dr Joey Gouws – Deputy Registrar
Dr Sybil Seoka – Deputy Registrar
Other MRA Staff
Consultants
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Backlog Project
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Consultants worked with MRA staff
Audit conducted and inventory list created
Industry assisted with audit from their side
Backlog cleared????
Suggestion to conduct audit with industry on
Clinical Trials and Amendments
Backlog project end date 30 June 2010
How to prevent a repeat????
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Communication with MRA
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PMT Received questions from associations
Questions related to SAHPRA or both SAHPRA
and MRA were addressed
MRA specific questions referred to Registrar
e.g.
- CTD and eCTD guidelines
- Implementation of safety update guidelines
- Finalisation of CAMS regulations
- SACRA request for MCC workshop
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Introduction to SAHPRA
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Act 72 of 2008 signed but never
promulgated
Abolishes MCC and creates SAHPRA
Covers products and medical devices
Minister appointed Dr Crisp as project
leader to create public entity
SAHPRA to operate from Civitas
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Introduction to SAHPRA continued
Principal Project Team members:
 Dr Nicholas Crisp
 Dr Johan van Heerden
 Carol Fries
 Elsabe Klinck
 Others: Finance, HR, Communication, IT,
Labour relation etc
 Timeline to implement new RA is Dec 2011
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MRA and SAHPRA Fee Structure
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Need for staged increase of fees
Current fee structure assessed
Industry budget planning taken into consideration
PMT to engage with industry on proposed fees by
20 July 2010
Devices to be discussed separately
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MRA Communication with Industry
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Industry Task Group (ITG) revitalised
Structured communication framework
Joint letter to Registrar
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SAHPRA Communication with Industry
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SAHPRA PWG main contact point
Establishment of sub working groups
Communication will be transparent and
inclusive
MRA specific issues to the Registrar
PMT to set agendas for meetings
2 Reps per organisation on PWG
Meetings planned for July, Sept and Nov
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Additional items raised
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Veterinary Regulatory Authority
Consumer Protection Act
MRA move to Civitas
EDMS
MRA Website
ITG
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THANK YOU
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