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FEEDBACK ON MCC PROJECT MEETING HELD ON 14 MAY 2010

FEEDBACK ON MCC PROJECT MEETING HELD ON 14 MAY 2010. Dr Dorcas Peta 4 JUNE 2010. 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

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FEEDBACK ON MCC PROJECT MEETING HELD ON 14 MAY 2010

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  1. FEEDBACK ON MCC PROJECT MEETING HELD ON 14 MAY 2010 Dr Dorcas Peta 4 JUNE 2010

  2. 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

  3. Project Management Team (PMT) • 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

  4. Backlog Project • 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????

  5. Communication with MRA • 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

  6. Introduction to SAHPRA • 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

  7. 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

  8. MRA and SAHPRA Fee Structure • 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

  9. MRA Communication with Industry • Industry Task Group (ITG) revitalised • Structured communication framework • Joint letter to Registrar

  10. SAHPRA Communication with Industry • 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

  11. Additional items raised • Veterinary Regulatory Authority • Consumer Protection Act • MRA move to Civitas • EDMS • MRA Website • ITG

  12. THANK YOU

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