SAHPRA

Webinar | Importance of Reporting Adverse Events to SAHPRA | #MedSafetyWeek
2023-11-06 18:00 - 19:30 (Africa/Johannesburg) | Virtual
The South African Health Products Regulatory Authority (SAHPRA) is commemorating the #MedSafetyWeek2023 campaign, in collaboration with South African Pharmacy Council (SAPC), by hosting a webinar focused on the Importance of Reporting Adverse Events.
The #MedSafetyWeek is an international social media campaign organised every year by the Uppsala Monitoring Centre (UMC) to raise awareness of adverse events and national reporting systems.
You have an opportunity to learn and engage with SAHPRA and SAPC colleagues on key safety and reporting issues.
What you will learn about:

Reporting side effects
Side effects experienced at health facilities
Role of pharmacies and patient safety

Date: 06 November 2023
Time: 18:00

Presentations:
JHB Health District
Expanded Program On Immunisation In South Africa

Webinar recording:

Radiation Control’s Regulatory Compliance Webinar
2023-10-25 10:00 - 11:30 | Virtual
The Radiation Control (RadCon) Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an informational webinar to increase awareness and understanding of radiation control regulatory processes.
You have an opportunity to learn and engage with SAHPRA colleagues on key regulatory compliance processes within the RadCon unit.
What you will learn about:

Regulatory processes
Understanding the licensing process
Role of sub-units within RadCon
Diagnostic and inspection process

Presentations:
SAHPRA Compliance Requirement
RADIATION CONTROL REGULATORY COMPLIANCE
Webinar Recording:

Webinar on Demystifying Hepatitis
2023-07-26 10:00 - 11:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted an exciting conversation on Demystifying Hepatitis to bring more awareness to World Hepatitis Day, celebrated annually on 28 July.
We have invited panellists from various sectors to share their knowledge, experience, and expertise to begin this important conversation focusing on the:

Understanding the basics of hepatitis
How to identify symptoms
Prevention of hepatitis

Date: 26 July 2023
Time: 10:00
Presentations:
Understanding Hepatitis B and C and the 2030 elimination targets
Hepatitis B infection status among South Africans attending public health facilities over a five-year period: 2015 to 2019
Recording below:

Upcoming Workshop: QOS/QIS and Variation Validation Template
2023-05-22 09:00 - 11:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a workshop to share useful information on populating the QOS and QIS as a replacement for the SCoRe document, as well as information on the Variations Validation template.
Date: 22 May 2023
Time: 09:00 – 11:00
Watch Recording

Webinar on Unpacking Malaria on World Malaria Day
2023-04-25 10:00 - 11:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar to increase awareness and understanding of malaria this World Malaria Day.
The purpose was for the public to learn and engage with experts on malaria.
We had invited panellists from various sectors to share their knowledge to continue this important conversation focusing on the:

Basics of malaria
Approved health products to combat malaria
Malaria prevention and control
Drug resistance surveillance

Watch recording below

Date: 25 April 2023
Time: 10:00
Register NOW: bit.ly/3KTF8Ho

Webinar on Radiation Control Engagement with Inspection Bodies
2023-02-24 10:00 - 12:00 | Virtual
The Radiation Control Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an engagement with Inspection Bodies.

We have invited several Inspection Bodies to share their knowledge, experience, and expertise to begin this conversation focusing on the:

Accreditation process by the South African National Accreditation System (SANAS)
Approval process by SAHPRA
Conditions and scope of the Approved Inspection Authorities (AIA)
Improving the workflow of electronic submissions
Improving the quality of QC reports

Recording below:

Webinar on Increasing Awareness and Reporting of Medication Errors
2023-02-23 10:00 - 11:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a conversation on what medication errors are and why it is vital that patients or healthcare professionals report them.
We have invited panellists from two hospitals to share their knowledge, experience, and expertise to begin this important conversation focusing on:

What are medication errors and their impact on patients
Importance of reporting medication errors
Role of SAHPRA in preventing medication errors

Date: 23 February 2023
Time: 10:00 – 11:30
Download presentations
Recording

Webinar | SAHPRA – What We Do And How We Work
2022-11-22 12:00 - 13:30 | Virtual
The South African Medical Association, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), invites you to a webinar that will provide a detailed introduction to the regulator and how it ensures the safety, efficacy and quality of medicines, medical devices and IVDs in South Africa.
The legislative mandates of SAHPRA, as per the National Health Act, 2003 (Act No. 61 of 2003); the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended; and other relevant legislation, regulations and policies will also be explained.
Webinar recording

The Interpretation of Calibration Certificates for Radiation Monitoring instruments
2022-11-10 09:00 - 10:30 | Virtual
The Radiation Control Unit of the South African Health Products Regulatory Authority (SAHPRA) held a short and free webinar that intends to educate you on how to interpret the calibration certificates for radiation monitoring instruments.
We have invited panellists from two sectors to share their knowledge, experience, and expertise to begin this conversation by focusing on the:

Primary objectives of calibration,
How to use calibrated instruments correctly,
How to interpret calibration certificates, and
How to apply the information provided on the certificate.

Hear from various speakers within the South African Nuclear Energy Corporation and the National Metrology Institute of South Africa.
Watch Recording here:

SAHPRA unpacks global accolade upon receiving WHO Maturity Level 3 (ML3)
2022-10-26 12:00 - 13:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a conversation on our recent accolade of attaining the World Health Organisation (WHO) Maturity Level 3 (ML3) for vaccine production.
We had invited some of our Executives, CEO Dr. Boitumelo Semete-Makokotlela, CRO Portia Nkambule, and COO Christelna Reynecke to unpack this global accolade by sharing insights and the impact of receiving this WHO rating.
Our conversation focused on:

Understanding of the opportunities that come with an ML3 ranking for South Africa
Improved understanding of the influence of ML3 on the African vaccine production industry
The impact of ML3 on the South African economy and its citizens

Watch webinar recording below:

Conformity assessment bodies meeting with SANAS
2022-10-05 09:30 - 12:30 | Virtual
SAHPRA invited all local and foreign Conformity assessment bodies to a joint meeting with SANAS.
The session is scheduled as follows:
Download Agenda
Recording below:

A Conversation on Medicine Safety - Increasing Awareness and Reporting of Adverse Events
2022-09-26 10:00 - 11:30 | Virtual
In commemoration of World Patient Safety Day and World Pharmacist Day (observed annually on 17 and 25 September, respectively), the South African Health Products Regulatory Authority (SAHPRA) hosted a Medicine Safety Webinar on 26 September 2022.

The webinar focused on increasing awareness and reporting of adverse events including medication errors, as we create a healthier world.

We have invited panellists from various sectors to share their knowledge, experience, and expertise to begin this important conversation focusing on the:

Global Perspective on World Patient Safety Day | World Pharmacist Day
Role of the South African Pharmacy Council (SAPC) in the promotion of medicine safety
Role of SAHPRA in the promotion of medicine safety | Med Safety App

Hear from various speakers within the South African Pharmacy Council, the University of KwaZulu-Natal and industry.

Webinar recording:

Workshop - Pharmacovigilance Systems
2022-08-30 09:00 - 12:00 | Virtual
The SAHPRA Vigilance and Inspectorate units hosted a workshop on the Pharmacovigilance Systems’ Guideline for Holders of Certificate (HCR).
The workshop is scheduled for:

Date: 30 August 2022
Time: 09h00 – 12h00
Registration link: https://bit.ly/pv-systems-workshop

Event recording:
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Webinar - Good Regulatory Practices and its implementation in the Medical Devices Sector
2022-08-11 14:00 - 16:00 | Virtual
We are pleased to invite you to participate in an online webinar on “Good Regulatory Practices and its implementation in the Medical Devices Sector” that will take place on 10 and 11 August 2022 under the joint work of the COVID-19 Medical Device Regulatory Convergence Project (MDRC) and the South African Health Products Regulatory Authority (SAHPRA). The program for the event is attached which includes recognized subject matter experts from the World Health Organization and World Trade Organization, amongst others.
This is the first in a series of workshops being organized under the MDRC coordinated efforts with SAHPRA on capacity building with relevant stakeholders regarding the development of capacities on Good Regulatory Practices and Good Reliance Practices for Medical Technology Regulation through the utilization of international references and standards.
To participate, please register via the following link through which you will receive a personalized link to connect to the two sessions
https://us06web.zoom.us/webinar/register/WN__zCfGnPqQO6JRKwrhZpGjQ
We look forward to your engagement,
Sincerely,
Sandra Ligia González Dimakatso Mathibe
Tier 2 (MedTech) Lead – MDRC Snr Manager, Medical Device Unit – SAHPRA
slgonzalez@standardsalliance-mdrc.org dimakatso.mathibe@sahpra.org.za

Webinar: Updates on Adverse events following Immunization
2022-08-04 09:00 - 10:30 | Virtual
South African Health Products Regulatory Authority (SAHPRA) held a live media briefing where we provide an update on Adverse Events Following Immunisation. Representatives of SAHPRA and the Minister of Health, Dr Joe Phaahla were in attendance.
When did it happen?
04 August 2022

Watch the webinar recording below:

Webinar: Launch of SAHPRA’s Online OTC Medicines’ directory
2022-06-30 09:00 - 10:30 | Virtual
South African Health Products Regulatory Authority (SAHPRA) hosted a live webinar launching our new and first-of-its-kind Online Directory for over-the-counter (OTC) medicines in South Africa.
When did it happen?
30 June 2022

Watch webinar recording below:

Webinar: Codeine-Containing Medicines - Unpacking the dangers and abuse
2022-06-21 10:30 - 12:00
SAHPRA hosted a Live Webinar: Codeine-Containing Medicines – Unpacking the Dangers of Irresponsible Behaviour and Abuse.
Recording below:

SAHPRA Industry workshop
2022-04-14 09:00 - 12:30 | Virtual
The purposes of the webinar are to provide clarification on the responsibilities of SANAS and SAHPRA with regards to Conformity Assessment Bodies (CABs) operating in South Africa and to have a discussion on the renewal process and expectations from the industry and SAHPRA.
Date: Thursday, 14 April 2022
Time: 09h00 – 12h30

Download presentations

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3rd World Conference on Pharmacometrics (WCoP)
2022-03-29 08:00 - 2022-04-01 17:00 | Century City Conference Centre, Cape Town, Western Cape, South Africa
The South African Health Products Regulatory Authority (SAHPRA) in collaboration with the Bill & Melinda Gates Foundation, CP+ Associates GmbH and Fundisa African Academy of Medicines Development, and after consultations with other African Regulators, convened a regulators expert meeting at the upcoming World Conference on Pharmacometrics (WCOP) that was held in Cape Town, South Africa in 2022.
SAHPRA organisers hosted side meetings during the conference where two (2) sessions were convened. The first reported on progress on capacity strengthening for African regulators, and the second had a specific focus on capacity development for using model-based analyses and pharmacometrics to support regulatory decision making.
The meeting was aimed at achieving the following objectives:
Primary Objective: Seek alignment and consensus from regulatory leadership on the continent on regulatory science capacity development.
Secondary Objectives:

Explore options to build capacity in regulatory agencies in Africa
Determine tools that would be put in place to assess/grade the level of capacity developed
Explore approaches to increase regulators capabilities to review clinical data in dossiers
Develop a Roadmap for capacity development
Collate input from other regulators regarding training programmes that should be implemented going forward

Date/Time:

29 March 2022 – 15:00 – 17:00 SAT
30 March 2022 – 17:00 – 18:00 SAT

Event programme Note of Gratitude Download Presentations

Gallery:

Vaccine Safety: Side Effects & Adverse Events Following Immunisation (AEFIs) Webinar
2022-03-15 10:00 - 11:30 | Virtual
As part of its ongoing response to COVID-19 communications and following a series of successful public events, the South African Health Products Regulatory Authority (SAHPRA) will be hosting a Webinar on “Vaccine Safety and Adverse Events”. The propose of the Webinar is to provide a platform for dialogue and information sharing on AEFIs.
Date: Tuesday, 15 March 2022
Time: 10h00 – 11h30
Speakers
1. Prof Hannelie Meyer, NISEC committee chairperson
2. Prof Marc Blockman, Chair of SAHPRA’s Pharmacovigilance advisory committee
3. Ms Mafora Matlala, SAHPRA Pharmacovigilance Manager
Download speaker bio’s

Watch recording

Update on COVID-19 Therapies
2022-02-21 11:30 - 12:30
SAHPRA was joined by experts to discuss the latest updates on Covid-19 therapies.
Date: Monday, 21 February 2022
Time: 11h30 – 12h30
Speakers
1. Dr. Boitumelo Semete-Makokotlela, SAHPRA CEO
2. Prof. Hannelie Meyer, NISEC committee chairperson
3. Prof Andy Parish, HOD of Internal Medicine (Walter Sisulu University)
4. Dr Jeremy Nel, Infectious Diseases Specialist (Wits University)
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Mitigating COVID-19 Vaccine Hesitancy in South Africa
2021-11-10 10:00 - 11:30

Enhancing the public trust in COVID-19 vaccination
2021-11-09 12:30 - 13:30
Enhancing the public trust in COVID-19 vaccination: Progress and challenges in the regulation, administration and rollout of vaccines in South Africa.
The race for countries to reach herd immunity continues globally. The prolonged Covid-19 pandemic has adversely affected the social and economic standing of many nations and South Africa is no exception. While vaccines bring a glimpse of hope the reality remains, that the successful administration and rollout of Covid-19 vaccines is largely dependent on the enhanced public trust of the vaccines and related institutions. It is also appreciated that the rise of vaccine-related conspiracy theories and myths counter noble global efforts in fighting the Covid-19 Pandemic.
Scifest Africa hosted a webinar that explored the progress and challenges related to the regulation, administration and rollout of Covid-19 Vaccines in South Africa.
The discussion tackled the role of enhanced public trust in attaining vaccination goals as set by the government. The webinar will also investigate the projected impact of Covid-19 vaccine passports in accelerating vaccination for the South African population.

Watch the video below:

Self-reporting suspected adverse drug reactions (ADRs) of medicines and vaccines webinar
2021-09-13 11:00 - 12:30 | Virtual
In February 2021, South Africa’s National Department of Health (NDoH) embarked on a nationwide COVID-19 vaccine rollout plan. The phased approach to immunisation ramped up in July 2021, with a record number of individuals (over a million in a single day) registering for their doses.

AEFI reporting microsite media briefing webinar
2021-08-20 14:00 - 16:00
The South African Health Products Regulatory Authority (SAHPRA), invites you to the launch of the Adverse Events Following Immunisation (AEFI) reporting microsite.
The microsite will keep the public updated on reports of adverse events following immunisation (AEFIs) associated with COVID-19 vaccine administration. All medicines, including vaccines, can cause side effects. In the case of vaccines, side effects or adverse events that occur after vaccine administration are known as AEFIs. However, the benefits of COVID-19 vaccination outweigh the risks. COVID-19 vaccines have proven to prevent severe forms of disease, hospitalisation and death.
Watch the webinar below:
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SAHPRA COVID19 Response Webinar
2021-07-01 10:00 - 11:00
SAHPRA and PATH hosted a webinar panel discussion on the coordinated introduction of COVD19 vaccines and tools and the important role of the South African Health Products Regulatory Authority (SAHPRA) and the National Department of Health in COVID19 vaccine planning and roll-out whilst ensuring equitable access and safety for all South Africans.
Watch the webinar below:
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The Process of Vaccine Approval webinar
2021-06-24 10:00 - 11:00
The normal process for the evaluation of a vaccine necessitates that all the required information regarding product safety, efficacy and quality be provided at the time of submission. In other words, all the clinical trial data for safety and efficacy from phase one to three should be provided together with manufacturing information of the product quality.
In an effort to respond to the pandemic, SAHPRA introduced another mechanism to facilitate the review of COVID-19 applications, which is the rolling review process. The rolling review is a mechanism that facilitates the submission of data as it becomes available. This webinar will focus on the vaccine approval processes.
Watch the webinar below:
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eCTD Go-live in South Africa
2016-11-19 09:00 - 16:00
The Medicines Control Council (MCC) went live with eCTD for New Chemical Entities on 01 April 2016, and the intended go-live date for generic applications is 02 January 2017.
Find out more

Immunogenicity of Biopharmaceuticals workshop
2016-07-05 09:00 - 2016-07-10 17:00 | Osaka, Japan, Japan
The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016. As part of the objective to extend its global outreach, ICH is pleased to welcome the Agência Nacional de Vigilância Sanitária (ANVISA) from Brazil and the Ministry of Food and Drug Safety (MFDS) from South Korea as the first new regulatory Members, together with the Biotechnology Innovation Organization (BIO) as a new industry association Member.
Find out more
