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 5th 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: 26-27 July 2011 Objective:

Strengthening the Research, Innovation and Development.

NATIONAL HEALTH RESEARCH SUMMIT(2/7)

Day 1S.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 25 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 2011. 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 R32 000 of the R40 000 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 collaboration1. September- nominations2. October voting

SACRA Excellence awards: November 18 AGM1. Online submissions from end May 2011. 2. Submission close September 20113. Read Criteria carefully

2010 SACRA Award Recipients