SACRA & Industry July News

Welcome to the SACRA July News update

In order to ensure that we balance communicating urgent industry news in a timely manner with keeping members informed of upcoming meetings, regulatory updates and sector project progress, and achieve all this without overloading your inbox, we will try to condense some items into newsletter style update.

If you have any constructive feedback on this new format, please send your comments to barbara@sacraza.com.

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CIVITAS

Operational hours for Submissions.

We have been notified that the operational hours at the Department of Health is up until 13h00 each day until further notice. Please ensure that all deliveries are scheduled to be completed before 13h00.

Contact details are now contained in the CTF 1v2 document linked here.

If you have questions about this trial, you should first discuss them with your doctor or the Ethics Committee. After you have consulted your doctor or the Ethics Committee and if they have not provided you with answers to your satisfaction, you should write to the South African Health Products Regulatory Authority (SAHPRA) at: The Acting Chief Executive Officer Medicines Control Council

South African Health Products Regulatory Authority Department of Health, Private Bag X828, PRETORIA, 0001

Tel: 012 395 8126 Email: Portia.Nkambule@health.gov.za

We have received the following four (4) revised documents from SAHPRA: (Click the link to download)

CTF 1 - 05.2018 v3.pdf

Post Clinical Trial Access 05.2018 v1.pdf

Participant Compensation Model.pdf

Progress Report - 05.2018 v2.pdf

DoH National Health Research Committee Summit

September 13th & 14th, 2018.

National Health Research Committee (NHRC) extends the invitation below to all Pharmaceutical companies that participate in the Industry Task Group.

Find here a formal Invitation letter to Pharmaceutical Companies, to attend the 2018 National Health Research Summit that will be held from 13 - 14 September 2018 for pharmaceutical Companies affiliated to Industry Task Group.

Please note that the proposed venue for the event is The Garden Court OR Tambo but yet to be confirmed by the Director-General: Health.

Meeting Concept note

Kindly circulate to all the affected pharmaceutical companies.

Kind regards

Mpho Kgasi

NHRC Secretariat

Directorate: Health Research

Tel: 012 395 9029

Mpho.Kgasi@health.gov.za

Rachael.Sanyane@health.gov.za

RSVP by 24 August 2018

To: Dr Tshilidzi Muthivhi

Email: Tshilidzi.Muthivhi@health.gov.za

Tel: (012) 395 8125

SACRA Conference 2018

PLEASE TAKE NOTE OF DATE CHANGE!! 26th - 28th September

SACRA September dates have been changed to 26th - 28th September due to SAHPRA Summit taking place at the same time as the initial date: September 12th-14th, 2018. Please register and save the date for a Conference that promises to be outstanding.

Conference Sponsorships are still open: There is an opportunity to sponsor our national conference or book advertising space in the 2018 Conference Brochure. Our exhibition is fully booked!

Contact barbara@sacraza.com for more information.

Durban CPD Accredited Workshop and Certified IATA Training at subsidised rates:

July 26th & 27th is scheduled for SACRA’s Regional Workshop to take place in Durban.

A CPD and Ethics Accredited Workshop will be held at the UKZN Medical School Krith Towers - Room K1 on Thursday 26th July at 17:00 -21:00.

The Workshop will be charged at a fee of R350 per person.

The IATA Accredited Training will be carried out at the same venue on Thursday 26th & Friday 27th from 8:30 - 16:00.

To book your space among the 20 seats available, or to confirm your attendance for the Workshop.

Contact barbara@sacraza.com for more information.

Click the links below to download the course outline and agenda.

IATA Training Outline

Workshop Agenda

REVIEW

We have been made aware of the following regulatory document that has been released for comment:

Medicines and Human Reproduction

This guidance document is intended to provide guidance to applicants regarding the safety assessment and labelling of medicines with regard to human reproductive health.

Please submit any comments to barbara@sacraza.com (for collation and submission by SACRA) before Tuesday 24 July 2018. The deadline for comments submitted directly to SAHPRA is Tuesday 31 July 2018.

Guidance Document.pdf

INDUSTRY NEWS

Various PIC/S meetings took place in Geneva, Switzerland from 16-18 April 2018.

Please find the press release from PIC/S. CLICK TO VIEW

The Ethics and Governance Framework for Best Practice in Genomic Research and Bio-banking in Africa was released by the H3A Working Group on Ethics on 18 April 2018 in the journal Nature. CLICK TO VIEW

SACRA SECTOR PROJECTS

Investigators

SOPs have recently been in the spotlight with some sites and CRAs reaching out to SACRA to look for guidance on the compilation of these documents.

See Dr Essack Mitha’s take on this in the SOP Blog posted on the SACRA website in June.

CLICK TO VIEW

Please see an update on the Clinical Trials in a Nutshell programme from Dr Tayob.

CLICK TO VIEW

CROs

SACRA is working on a blog post to provide useful information regarding the structure and functioning of our new regulator. Please keep a look out for it.

Mr Andy Gray published an article on Medicines Control Council - a century of regulatory process, before the transition to SAHPRA in the South African Pharmacy Journal.

CLICK HERE

Please email us with any suggestions, comments or feedback: barbara@sacraza.com