2011 August 5 Johannesburg

Updates of 2011 activity Sector Updates  Service Providers (Natalie): SACRA/TNT Information pack / IATA workshop (JNB meeting)  CRO & Pharma: Manager’s meeting on monitoring 26Aug10  Investigators: Inclusive topics at SACRA meetings Sector Updates  Workshop August 5, 2011 SACRA Awards of Excellence (Barbara) DoH Health Summit July 2011 (Tebogo) ITG update (Judith) MCC task group (Judith) PIASA/SACRA initiative

Service Providers (Natalie Sandeman) Export Permit Information Pack: Questions gathered from members and answered by Department of Health Information compiled in an information pack/booklet (A6 format) Distribution to all members nationally Address members on 5 th of August 2011 (JNB) - best practice distribution; maintaining confidentiality; whom should receive information packs

Sample view:

Service Providers (Natalie Sandeman) Finalize information pack: Mid August 2011 Finalize printing of pack: End August 2011 Distribution to members: September 2011 Possibility of an electronic “working” document on website – additions / changes SACRA member feedback session: last member meeting 2011

Service Providers (Natalie Sandeman) Export Permit Information Pack Content: Background DoH Line Management Structure Application document completion Application process Export permit issue process Follow up process Escalation process FAQ’s

Service Providers (Natalie Sandeman) IATA: World Courier Service Provider Workshop – August meeting (JNB) – CPT & BFN meetings TBC Workshop content: IATA training certification / accreditation requirements Roles & responsibilities Workshop outcome: SACRA member feedback session: November meeting

CRO (Catherine Lund) On-going discussions surrounding consistency and availability of training of CRA’s across all sectors in SA Difficult to define or measure Hence managers meeting – August 2011 – discussion of level of quality, actual and potential obstacles and way forward

Investigators (Dr Luthando) SACRA Collaboration with MCC inspectorate to feedback common trend findings and SACRA to develop training to boost site performances (was meant to have kicked off at this meeting but due to scheduling conflict for MCC – postponed)

Update from Meetings/Industry (Judith Ramuthaga) DoH Health Summit : (Tebogo/Judith) ITG update (Judith) MCC Task group (Judith) Netcare Research collaboration PIASA/SACRA initiative (Savi)

NATIONAL HEALTH RESEARCH SUMMIT(1/7) Date: July 2011 Objective: Strengthening the Research, Innovation and Development.

NATIONAL HEALTH RESEARCH SUMMIT(2/7) Day 1 S.W.O.T analysis on the 6 domains:-  Analysis of Research in HIV/AIDS and TB  Analysis of Research in Maternal Health  Analysis of Research in Non-communicable diseases  Analysis of Research in Violence and injury  Analysis of Operational and Health Systems  Analysis of Basic and Clinical Research in SA

NATIONAL HEALTH RESEARCH SUMMIT(3/7) Day 2 5 Parallel Commissions  What research is required to achieve an increase in life expectancy  What research is required to reduce maternal and child mortality rates  What research is required to combat HIV/AIDS  What research is required to strengthen the effectiveness of the health system  How can SA build its health innovation system and ensure that the objectives of the “WHO Global Strategy and Plan of Action for Public Health Innovation and Intellectual Property” are achieved

NATIONAL HEALTH RESEARCH SUMMIT(4/7) Way forward: Process Report to be submitted by NHRC on 15 Aug 2011 Delivery of White paper through Delphi process 4 expert panel to be set – from the meeting delegates to advice. 10 people in each panel = 40people

NATIONAL HEALTH RESEARCH SUMMIT(5/7) The group will have x2 rounds of meeting to identify priority areas Revice views based on discussion in the meeting Timelines to be set. Achieve consensus on x3 priorities early Dec 2011.

NATIONAL HEALTH RESEARCH SUMMIT(6/7) Resolution of the Summit: Acceptance of the process for identification of the priorities Complete White Paper by Dec 2011 and submit to the Minister of Health. Submit Publication on “Research for Health” or other appropriate topic in the May 2012 issue of Plus Medicine?

NATIONAL HEALTH RESEARCH SUMMIT(7/7) Clarification of other concerns: NHRC will set research questions. White paper will advice future policy. The process will assist in getting funding for Research for Health from Treasury with more guidance from the White Paper. Expert Panel will be multidisciplinary. Monitoring system to be put in place by NHRC. This process will be evaluated every 5years.

ITG update (1/3) Summary of meeting held on 31 May 2011 Portia Nkambule represented the clinical trial committee Administration: 3 of the 4 vacancies filled Vacancy for Pharmacovigilance to be filled. Clinical trials: CTF1 and other forms are in review process- input from industry welcomed EU guidelines for AE reporting recently updated and will be sent to Portia.

ITG update (2/3) Clinical trials submission: Extraordinary meetings scheduled for Fridays to review of all submission per cycle. Applicants to respond to queries speedily Protocol amendments to be submitted simultaneously in word format on a CD. Quality of submission has improved. Payments to be made per submission- avoid advance payments Avoid bulk payments of different submissions

ITG update (3/3) Phase IV studies : Notification if in line with PI and locally registered medicine will be used. CTF1 to be submitted if product sourced overseas. Section 21: Companies to inform MCC if payments have been made even if made in advance Problems are experienced from hospitals and patients State institutions don’t pay for section 21.

MCC task group All submission forms to be reviewed

Research in Netcare facility (1/5) Meeting held on 5 July 2011 with the General manager (Education) and Project manager (Bursaries and Research) All research within Netcare facility has to be submitted to Netcare Research Committee. Netcare Research Committee is not an Ethics committee. Application process clearly documented in The Standard Operating Procedure: Application for approval of research, Version 1. Each protocol is submitted separately

Research in Netcare facility(2/5) Requirements for application: The applicant must always be the Principal Investigator. Independently submitted. Both MCC and Ethics signed approval letters. Acknowledgement letter from Netcare Hospital manager. Note: this is not an approval letter. Indemnity letter if Netcare staff is used. This is effective from 1 July No facility or submission fee required.

Research in Netcare facility(3/5) Progress report to be submitted as per SOP. PI must provide approval letter before any study starts. Review process takes 2-3 weeks – communicate any urgency for review in advance. Any two members of the committee may sign the approval letter if all requirements fulfilled.

Research in Netcare facility (4/5) Suggestions agreed upon: Sponsor may assist PI to ensure complete submission dossier – PI must sign all relevant documents. One submission for multiple hospital provided: All PIs sign own application form & CVs Individual netcare acknowledgement letters Proof of all PI approved by Ethics and MCC. ICF may be in line with Ethics requirements.

Research in Netcare facility(5/5) Clarifications: Archiving is dependant on requirements according to legislation – 15years can be done. All netcare sites have to apply Application process is quick if all docs are complete. Sponsor may overcome potential delay- communicate the urgency of the study in advance File retrieval process differ from one hospital to the other.

PIASA/SACRA marketing initiative Raised R of the R target. Pending pledge confirmations still Plan for investigator database on the SA Clinical Research Website ( need funds!) Draft content prepared. For review and feedback Launch of initiative by PIASA at the Research Summit 26-27July Collaborator input will be invited soon…

Dispensing License Legal review completed Proposals to still be tested at the DG level : In terms of the Medicines Act, section 21 authorisations are granted with permission to dispense at such sites, without the site and professionals requiring a dispensing licence, but that conditions be set to ensure the trial medication is kept in line with proper Good Pharmacy Practice principles. This power would need to be exercised by the MCC. Report proposal to be discussed with the DG of DOH to agree on a solution That nurses in clinical trial sites obtain dispensing licences in terms of section 22C to the Medicines Act, dispensing the medicine on the prescription of the investigator(s) at the site. This power would be exercised by the DG (DoH). That nurses in clinical trial sites be designated under the special circumstances envisaged by section 56(6) of the 2005-Nursing Act. This designation would require the DG to consult with the Pharmacy Council prior to making such a designation

SACRA Document Review DOH Imports Export Bill Input into the Tax Amendment Bill Plan to review: Medicines and Substances Related Act Medical Devices Medicines and Substances Related Act – general ADR – post marketing

Up-Coming events 2011-Barbara  Conference 2012: September 13 & 14  Online abstracts from June 2011  General information and registration from early June 2011  SACRA Exco Elections 2012: September nominations  Think about Sector collaboration 1. September- nominations 2. October voting  SACRA Excellence awards: November 18 AGM 1. Online submissions from end May Submission close September Read Criteria carefully

2010 SACRA Award Recipients