About the Event

The ISoP- Africa chapter meeting, will gather over 250 pharmacovigilance experts, regulators, and industry professionals to discuss “Opportunities and key challenges for enhancing patient safety in Africa“.

Advancing Pharmacovigilance Practice in Africa: Moving from Data collection to Data Driven Decision Making.

Thematic Areas

  • Signal management and risk communication
  •  Regulatory harmonization for pharmacovigilance
  • Digital health and patient engagement in pharmacovigilance
  •  Pharmacovigilance in Africa – a manufacturer’s perspective
  •  Impact of the African genetic background on adverse events and the future pharmacovigilance
  • Active monitoring of vaccines and medicines

ISoP Africa Chapter 2024 Annual Meeting

08:00 - 09:00 Registration
  • Dr. Jayesh M. Pandit
  • Comfort Ogar
Session 1: Advancing PV Data-Driven Decision Making in Africa

Chairpersons

B. Pharm, M. Pharm (Pharmacy Practice), Bayer East Africa Ltd
United States Pharmacopeia
  • Kenneth Onu
09:10 - 09:30 Data Collection to Data-Driven Decision-Making for Patient Safety in Africa: A case of the AU-3S pilot during COVID-19 pandemic in promoting patient safety
Principal Programme Officer, AUDA-NEPAD
  • Mulugeta Russom
09:30 - 09:50 Role of VigiLyze for signal detection and regulatory decision making - Experiences and lessons from Eritrea
FISoP, Eritrean Pharmacovigilance Centre
  • Dr Kimberley Gutu
09:50 - 10:10 Envisioning database networks for safety surveillance in Africa - opportunities and challenges
Project Manager, Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
  • Lebogang Koitsiwe
10:10 - 10:30 Use of RWD for PV data-driven decision: Experience from Botswana
Pharmacovigilance Manager, BoMRA
  • Peter Usman Bassi
10:30 – 10:40 Oral Presentation: Impact of serious adverse drug reactions on the quality of life of patients on highly active antiretroviral therapy
University/University Teaching Hospital, Nigeria
10:40 – 10:45 Sponsor Presentation

Deirdre McCarthy, Senior Program Officer, Integrated Development, Bill & Melinda Gates Foundation

10:45 – 11:15 Coffee Break and Poster Session
  • Peter Usman Bassi
  • Mulugeta Russom
Session 2: Signal Management and Risk Communication

Chairpersons

University/University Teaching Hospital, Nigeria
FISoP, Eritrean Pharmacovigilance Centre
  • Dr Ronald Kiguba
11:20 – 11:40 The Role of Patient Reporting in Strengthening Signal Detection in PV Databases
Senior Lecturer, Makerere University
  • Mulugeta Russom
11:40 – 12:00 Eritrea experience in signal management and risk communication: success stories, challenges and lessons learned
FISoP, Eritrean Pharmacovigilance Centre
  • Jackson Mukonzo
12:00 – 12:20 The Journey from Safety Signals to Risk Factors to Product Label - A Case of Efavirenz Signal Management and Risk Communication
Associate Professor and Chair Department of Pharmacology and Therapeutics, Makerere University
  • EDITH ANDREWS ANNAN
12:20 – 12:40 Utilization and impact of the WHO Global Surveillance and Monitoring System database
Technical Officer, Medicines and Health Technologies, WHO
  • Henry Zakumumpa
12:40 – 12:50 Oral Presentation: Patient experiences of sexual dysfunction after transition to dolutegravir-based HIV treatment in Western Uganda
Makerere University, Uganda
  • Christopher Cox
12:50 – 13:00 Oral Presentation: Signal Management and Risk Communication in Pharmacovigilance: Exploring Dynamics, Challenges, and Strategies in Uganda
Pharmacist, Mulago National Referral Hospital
13:05 – 14:00 Lunch
  • Peter Usman Bassi
  • Mulugeta Russom
Session 3: Vaccine Safety Monitoring in Africa

Chairpersons

University/University Teaching Hospital, Nigeria
FISoP, Eritrean Pharmacovigilance Centre
  • Uchenna Elemuwa
14:05 – 14:15 Enhancing Vaccine Pharmacovigilance and vaccine safety database: The role of National immunization Program
Director Pharmacovigilance, NAFDAC, Nigeria
  • Rebecca Chandler
14:15 – 14:25 Vaccine safety and pharmacovigilance within the context of CEPI’s 100 days mission
Clinical Development Vaccine Safety Lead, CEPI
  • Ombeva Malande
14:25 – 14:35 Vaccine hesitancy and the importance of safety monitoring in enhancing coverage for new vaccines
Director, ECAVI
  • Rebecca Chandler
  • Ombeva Malande
  • Hannelie Meyer
  • Uchenna Elemuwa
14:35 – 15:15 Panel Discussion: Vaccine Safety and Mitigating Vaccine Hesitancy
Clinical Development Vaccine Safety Lead, CEPI
Director, ECAVI
Professor, Department of Public Health Pharmacy and Management, School of Pharmacy, Sefako Makgatho Health Sciences University (SMU)
Director Pharmacovigilance, NAFDAC, Nigeria
  • Damas Matiko Nyang’anyi
15:15 – 15:25 Oral presentation: Strengthening the Adverse Events Following Immunization Surveillance System for COVID-19 Vaccine Safety Monitoring and beyond: a case of Tanzania
Tanzania Medicines and Medical Devices Authority (TMDA)
  • Comfort Ogar
15:25 – 15:35 Oral presentation: Patient Reported Outcomes of Adverse Events After COVID-19 Vaccination in Nigeria: A Mixed Methods Study
United States Pharmacopeia
15:40 – 16:00 Coffee Break and Poster Session
Conference Opening Ceremony
  • Helen Ndagije
16:00 – 16:10 Remarks from the President of The ISoP Africa Chapter
PhD, FISoP, Director Product Safety Uganda National Drug Authority
  • Angela Caro Rojas
16:10 – 16:20 Remarks from the President of ISoP Global
President, International Society of Pharmacovigilance (ISoP)
16:20 – 16:30 Remarks from the Secretary to the Authority

David Nahamya, Secretary to the Authority

16:30 – 16:40 Remarks from the Chairperson of the Board NDA

Dr Medard Bitekyerezo, Chairperson Board NDA

16:40 – 16:50 Remarks from AUDA-NEPAD

Symerre Grey- Johnson, Director Human capital and institutional development, AUDA_NEPAD

16:50 – 17:00 Speech from Country representative WHO

Dr Yonas Tegegn Woldemariam, Country Representative WH

  • HON. DR. JANE RUTH ACENG OCERO
17:00 – 17:15 Opening remarks/ Speech from the minister of Health
Minister of Health, Uganda
17:15 – 17:30 Photographs
18:00 - 20:00 Drinks Reception
  • Kate Kikule
  • Victoria Prudence Nambasa
Session 4: Regulatory Harmonization for PV

Chairpersons:

Senior Principal Technical Advisor, USAID MTaPS Program
African Union Development Agency-NEPAD
  • Helen Ndagije
08:50 – 09:10 The role of ISoP in the African Medicines Agency (AMA) Pharmacovigilance Framework
PhD, FISoP, Director Product Safety Uganda National Drug Authority
  • Angela Caro Rojas
09:10 – 09:30 ISoP Strategic Vision and How to Support Africa
President, International Society of Pharmacovigilance (ISoP)
  • Vanessa Msengezi
09:30 – 09:50 Updates on Regional PV Harmonization in Africa
African Medicines Regulatory Harmonisation Programme, AUDA-NEPAD
  • Victoria Prudence Nambasa
09:50 – 10:00 Oral Presentation: Assessing the maternal vaccine pharmacovigilance landscape in Uganda
African Union Development Agency-NEPAD
  • Thuli Makhene
10:00 – 10:10 Oral Presentation: Pharmacovigilance Guideline Harmonisation in Africa
Head of PV Sub-Saharan Africa, Bayer
10:15 – 10:30 Coffee Break and Poster Session
  • Dorothy Aywak
  • NIMISHA KOTECHA
Session 5: Pharmacovigilance in Africa: A Local Perspective

Chairpersons:

Kenyatta National Hospital
Managing Director, IntuVigilance Ltd
  • Dr. Jayesh M. Pandit
10:35 – 10:55 Why is Pharmacovigilance important to Africa?
B. Pharm, M. Pharm (Pharmacy Practice), Bayer East Africa Ltd
  • Frances Philomena Namatovu
10:55 – 11:15 PV from Local Manufacturers’ Perspective
QPPV, Quality Chemical Industries Ltd
11:15 – 11:35 PV from Local Distributors’ Perspective

TBC

  • Blessed Kitentera
11:35 – 11:45 Oral Presentation: Discovering the potential of local pharmaceutical manufacturers in Africa through effective pharmacovigilance
Mbarara University, Uganda
  • Michael Muhoozi
11:45 – 11:55 Oral Presentation: A cost-effectiveness analysis of active and passive vaccinovigilance of adverse events following Measles-Rubella Immunization for Children in Eastern Uganda
Health Services Researcher
12:00 – 12:50 Lunch
  • Comfort Ogar
Session 6: Active Monitoring of Medicines / Vaccines

Chairpersons:

United States Pharmacopeia
  • Omar Aimer
12:55 – 13:15 Navigating Challenges and Successes: Leveraging New Technologies in Adverse Event Reporting in the context of active surveillance
ISoP EC member and Treasurer, NASoP President, Medical Device SIG lead.
  • Dr Edinam Agbenu
13:15 – 13:35 The role of active safety monitoring of COVID-19 vaccines in maximizing reporting and enhancing the quality of immunization campaigns – experiences from Africa
Vaccine Safety Officer, WHO Regional Office for Africa
  • Prof Bernhards Ogutu
13:35 – 13:55 Combining data from clinical trials and post-introduction active safety monitoring studies to enhance safety decision-making
Senior Clinical Scientist, KEMRI
  • Aida Hagos
13:55 – 14:05 Oral Presentation: Leveraging COVID-19 Vaccine Safety Monitoring in Ethiopia and Pakistan to Enhance System-Wide Safety Surveillance
Technical Advisor on Pharmacovigilance and Product Safety for USAID-funded PQM+ program.
  • Kato Outhman Sengendo
14:05 – 14:15 Oral Presentation: Safety Outcomes of COVID-19 Vaccines in People Living with HIV: A Prospective Cohort Study in Uganda
Infectious Diseases Institute, Uganda
  • Jonans Tusiimire
14:15 – 14:25 Oral Presentation: Building Pharmacovigilance Capacity among Health Professionals in Uganda through Curriculum Intervention
Deputy Dean Faculty of Medicine, MUST
14:30 – 14:50 Coffee Break and Poster Session
  • Kennedy Odokonyero
  • CLARICE AMBALE
Session 7: Digital Health and Patient Engagement in PV

Chairpersons:

PV Consultant
Mpharm, Centre for Health Solutions - Kenya
  • Dr Ronald Kiguba
14:55 – 15:15 Using peer support to promote patient-led digital pharmacovigilance in limited-resource settings
Senior Lecturer, Makerere University
  • Helena Sköld
15:15 – 15:35 Health Data Analytics for Pharmacovigilance in Africa
Head of VigiBase and Regulatory Services, Uppsala Monitoring Centre, Sweden
  • Mohammed Fouda
15:35 – 15:55 Artificial Intelligence in Pharmacovigilance
Head, Signal Detection Section, Saudi Food and Drug Authority
  • Mick Foy
15:55 – 16:15 Using Technology for Better Data Collection in Pharmacovigilance
Mick Foy, Director of Delivery, MHRA
  • Kudakwashe Dandajena
16:15 – 16:25 Oral Presentation: Digital Transformation Approach for African Safety Surveillance: Insights from AU-3S Programme's Deployment Towards AfriVigilance
Principal Programme Officer Technology Strategy, AUDA-NEPAD
  • Deane Putzier
16:25 – 16:35 Oral presentation: Pharmacovigilance Monitoring System PViMS (OpenRIMS-PV) – A Digital Tool to Enhance Decision-Making for Active and Passive Patient Safety Monitoring
Senior Principal Technical Advisor, MTaPS program
16:40 Transport to the Gala Dinner Venue
18:00 - 21:00 Gala Dinner
  • Victoria Prudence Nambasa
Session 8: Impact of the African genetic background on AE and future PV monitoring

Chairpersons:

African Union Development Agency-NEPAD
  • Janine Scholefield
09:35 – 09:55 Using data precision medicine solutions to address adverse drug reactions
CSIR research group leader
  • Prof Bernhards Ogutu
09:55 – 10:15 Use of local African datasets to infer and predict high-impact drug-gene pairs to monitor and minimize ADR
Senior Clinical Scientist, KEMRI
  • Eshara Chotoo
10:15 – 10:35 The Implementation of Precision Medicine, an African Agenda from a Private Sector perspective
CEO, Antares Genomics
  • Kudakwashe Dandajena
10:35 – 10:45 Oral Presentation: Digital Transformation Approach for African Safety Surveillance: Insights from AU-3S Programme's Deployment Towards AfriVigilance
Principal Programme Officer Technology Strategy, AUDA-NEPAD
  • Dan Kajungu
10:45 – 10:55 Oral presentation: Assessing the background incidence rates of adverse events of special interest in obstetric and neonatal care using the GAIA in Uganda
Makerere University Centre for Health and Population Research (MUCHAP)
  • Aston Nuwagira
10:55 – 11:05 Oral Presentation: Transitioning Children to Optimized Regimens of Pediatric Dolutegravir ( TORPEDO) Study: Pharmacovigilance Endline Results in Uganda, Nigeria and Benin
Clinton Health Access Initiative, Uganda
  • Claudia Janice Latabu
11:05 – 11:15 Oral Presentation: Strengthening Pharmacovigilance using the COM-B Model at Facilities Starting Children on Dolutegravir-based Regimens in Uganda from January 2022 to December 2022
Infectious Disease Institute, Uganda
  • Dorothy Nakanwagi
11:15 – 11:25 Oral Presentation: Increasing the proportion of correctly documented adverse drugs (ADRs) at Mulago ISS Clinic, a high volume HIV care facility in Kampala Uganda
Senior Pharmacy Technician, Makerere University
11:30 - 11:50 Coffee Break
11:50 - 12:40 ISoP Africa Chapter- Business Meeting
12:40 - 14:20 Closing Ceremony
14:20 – 15:20 Lunch

PARTICIPATE IN OUR FIRST ISOP AFRICA CONFERENCE

Advancing Pharmacovigilance Practice in Africa: Moving from Data collection to Data Driven Decision Making.

Meet the SCIENTIFIC COMMITTEE

George Sabblah

Food and Drugs Authority

Helen Ndagije

Uganda National Drug Authority

COMFORT OGAR

United States Pharmacopeia

Dorothy Aywak

Kenyatta National Hospital

PETER USMAN BASSI

University Teaching Hospital

COYIE MATHENGE

CEO, PVCC Group

Victoria Nambasa

African Union Development Agency-NEPAD

Jayesh Pandit

Bayer East Africa Ltd

Nimisha Kotecha

IntuVigilance Ltd

MULUGETA RUSSOM

Eritrean Pharmacovigilance Centre

CLARICE AMBALE

Centre for Health Solutions

CHRISTABEL KHAEMBA

Pharmacy and Poisons Board
Hannelie Meyer

HANNELIE MEYER

Professor, Sefako Makgatho Health Sciences University

Meet the SPEAKERS

Angela Caro Rojas

ANGELA CARO ROJAS

President, ISoP

Dr. Jane Ruth Aceng Ocero

Minister of Health, Uganda
Chimwemwe Chamdimba

CHIMWEMWE CHAMDIMBA

Head AMRH, AUDA-NEPAD
Rebecca Chandler

REBECCA CHANDLER

Vaccine Safety Lead, CEPI

UCHENNA ELEMUWA

Director Pharmacovigilance, NAFDAC
Omar Aimer

OMAR AIMER

NASoP President
Edinam AGBENU

EDINAM AGBENU

Vaccine Safety Officer, WHO

BERNHARDS OGUTU

Senior Clinical Scientist, KEMRI

RONALD KIGUBA

Senior Lecturer, Makerere University

LEBOGANG KOITSIWE

Pharmacovigilance Manager, BoMRA

JACKSON MUKONZO

Associate Professor, Makerere University

Ombeva Malande

Director, ECAVI

Yodit Fitsum Ghebrezgabhier

PV Officer, Eritrean PV Centre
Kenneth Onu

Kenneth Onu

Principal Programme Officer, AUDA-NEPAD

JANINE SCHOLEFIELD

CSIR research group leader
Kimberley Gutu

KIMBERLEY GUTU

Project Manager, VIDA

MOHAMMED FOUDA

Signal Detection Section, SFDA

EDITH ANDREWS ANNAN

Medicines and Health Technologies, WHO

FRANCES NAMATOVU

QPPV, Quality Chemical Industries Ltd

ESHARA CHOTOO

CEO, Antares Genomics

MICK FOY

Director of Delivery, MHRA

Helena Sköld

Head of VigiBase, Uppsala Monitoring Centre

Vanessa Msengezi

AUDA-NEPAD

Our Sponsors

ELITE DIAMOND / EDUCATION Sponsor

Uganda National Drug Authority

PLATINUM Conference Sponsor

GOLD Conference Sponsor

SILVER Conference Sponsors

EXHIBITION Conference Sponsors

Registration FEES

PARTICIPATE IN OUR FIRST ISOP AFRICA CONFERENCE

ISoP Membership

  • Members of ISoP are eligible for the “member” rate. If the ISoP Africa Chapter cannot verify your current membership, you will be charged the non-member rate.
  • Non-member rates automatically include a one-year ISoP membership based on the selected fee category.
  • Information to activate your account and enjoy all ISoP membership benefits will be sent with your final confirmation.

Hotel Accommodation

Please note that hotel accommodation is NOT included in the registration fee and must be booked separately. We have secured preferred rates at the conference venue and you can use this link below to make the bookings.

Also there are a number of hotels close to the conference venue.

  • Serena Kigo – Link
  • Meley Impala Hotel – Link
  • Kalanoga resort – Link
  • Casa Solada Hotel – Link
  • Kaazi Beach Resort – Link

IntuVigilance Africa Ltd

Event Management Organisation is IntuVigilance Africa Ltd who is acting on behalf of ISoP Africa Chapter

Registration Terms and Conditions

  • Members of ISoP are eligible for the “member” rate. If the ISoP Africa Chapter cannot verify your current membership, you will be charged the non-member rate.
  • Non-member rates automatically include a one-year ISoP membership based on the selected fee category.
  • Information to activate your account and enjoy all ISoP membership benefits will be sent with your final confirmation.

Please note that there is a separate charge to attend the Gala Dinner – please indicate this when making a booking. There will be NO access to the dinner unless you have paid for this beforehand.

Please note that hotel accommodation is NOT included in the registration fee and must be booked separately. We have secured preferred rates at the conference venue and you can use the link below to make the bookings. Also listed are a number of hotels close to the conference venue.

Ugandan tourist visa costs $ 50. Tourist visa applications can be completed and paid for online at https://visas.immigration.go.ug/.

This event is being organised by The Africa Chapter of International Society of Pharmacovigilance (ISoP). By completing this registration form, you confirm and acknowledge that you are attending the event in your capacity as a healthcare professional or scientist.

In order to qualify for any ‘early bird’ rates, booking and direct payment received before the deadline date listed in the conference marketing material. Inclusive offers cannot be split between two people

All registrations must be completed (and paid) prior to attending the conference. Please note there will NO bookings taken on site.

Delegates may nominate an alternative person from their organisation to attend up to 48 hours prior to the start of the event, at no extra charge assuming that the substitute person holds the same membership status or additional fees may be required.

Should substitution not be possible, cancellation charges apply as follows:

  • 8 weeks or more prior to start of event: 10% of the delegate fee
  • 4 to 8 weeks prior to start of event: 50% of the delegate fee
  • 4 weeks or less prior to start of event: 100% of the delegate fee

All substitutions and cancellations must be received in writing by email to [email protected]

Our preferred method of payment is credit/debit card. We accept most credit/debit cards and you will have an option to pay via MTN mobile money, AIRTEL money or EZEE money.

It is the responsibility of the delegate to ensure payment is made. ISoP Africa Chapter will not chase sponsors or employers for payment on the delegate’s behalf.

Delegates will NOT be allowed to enter the event if the registration fee is not paid in full.

ISoP Africa Chapter reserves the right to postpone, alter and/or cancel all or any part of the event (including in-person day(s)) for any reason (including, without limitation, by reason of a force majeure).

In the event that all or any part of the event is postponed, altered or cancelled for any reason, delegates will be notified as soon as practicable prior to the advertised dates of the event. ISoP Africa Chapter accepts no liability in respect of any loss or damage, whether direct, consequential or otherwise arising from any alteration (including, without limitation, a change to the format of delivery of the event or a change of event venue), postponement (including, without limitation, any delay in providing the event), or cancellation of the event. ISoP Africa Chapter shall not be liable to delegates for any costs incurred in connection with accessing/attending the event.

ISoP Africa Chapter reserves the right to alter the programme and/or speakers without prior notice and without any liability to delegates. ISoP Africa Chapter does not accept responsibility for the views expressed by the individual speakers.

Please note that this event is kindly supported by a range of exhibitors and sponsors. ISoP Africa Chapter would like to thank the sponsors and all exhibitors for their support of the event. A full list of sponsors and exhibitors will be available on the event website. Sponsors and exhibitors have had no input into the arrangements for the event, including the agenda, content and speakers.

Photographs and video recordings may be taken and made at the conference by an official ISoP Africa Chapter photographer/ videographer. ISoP Africa Chapter may use these photos and videos in post-event publicity and on future marketing materials. In registering to attend the conference, delegates agree to the official photographer/videographer taking such photographs and videos, and to ISoP Africa Chapter using the photographs and videos as set out above. If you do not wish to be in any photography or video, you must notify a member of the ISoP Africa Chapter team immediately upon arrival at the conference for further guidance.

Delegates are not permitted to make their own video or audio recordings of any part of the event or use any photographs or videos for commercial purposes, unless they have ISoP Africa Chapter’s permission.

Please note: other attendees at the conference (delegates, speakers, exhibitors and sponsors etc.) may also take photographs and videos. ISoP Africa Chapter accepts no responsibility in connection with the use of these photographs or videos.

Delegates must not share any event content (including satellite symposia content) or access to such content with anyone else, in particular lay persons.

Delegates, including those sponsored or employed by pharmaceutical companies may not promote their sponsors and/or employers, or the products or services conducted by such sponsors and/or employers outside of their allocated exhibition stand (if relevant). This includes (without limitation) promotion by way of branded items, such as the wearing of branded clothing outside of the exhibition hall.

Canvassing for orders by delegates or any unauthorised person, including the display or distribution of materials, is strictly prohibited. Canvassing is only permitted by exhibitors (on their own stands), at sponsored satellite symposia (in agreement with ISoP Africa Chapter), via official promotion options and by authorised individuals.

ISoP Africa Chapter reserves the right, without any liability, to refuse a delegate access or eject them from the digital or in-person event for failure to comply with these Terms and Conditions; or if in ISoP Africa Chapter’s opinion a delegate represents a security risk, nuisance or annoyance to the running of the event. Delegates agree to follow all Covid-19 related rules and requirements imposed by ISoP Chapter Africa or the event’s venue, even where they go beyond Government guidelines.

ISoP Africa Chapter takes data protection and your privacy seriously. We will use the personal data you provide to us to:

Process your registration and provide applicable conference updates and services. We may need to share your data with third parties working for us, such as the conference venue and security providers. We will not provide or sell your personal data to other companies for marketing purposes without your agreement (see below for circumstances in which your information may be provided to sponsors or exhibitors).

ISoP Africa Chapter will not take responsibility for any personal information or data you choose to share with exhibitors or delegates directly at the event.

Abstracts

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