The power of regulatory reliance to improve patient access and deliver on the promise of the African Medicines Agency

8 March 2023 Kigali, Rwanda
Date

8 March 2023

Time

14:00 - 15:30 Kigali local time

Hosts

IFPMA

Location

Kigali Convention Centre, Rwanda

Attendance

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Regulatory reliance is an important tool to strengthen regulatory capacity and to make health systems more resilient. Agencies are using a risk-based approach for their local decision-making while taking regulatory assessments and actions from trusted peer regulators into account. Hence, reliance can be useful to increase the availability of medicinal products, while focusing regulatory human resources on higher risk activities. It has successfully been tested during the COVID-19 pandemic and should be used by regulators more broadly. 

This session will explore how regulatory reliance is leading to increased regulatory harmonization across Africa and is the foundation on which the African Medicines Agency will operate.

  • How does regulatory reliance work in practice?
  • How can its implementation accelerate access to medicines for patients?

These are the questions the session will seek to explain, using examples of successful regulatory reliance initiatives at the national, regional, and continental levels. The session will serve to build capacities in regulatory science amongst patient groups, community workers, CSOs, and grassroots health NGOs in Africa.

This session is organized as part of the 2023 Africa Health Agenda International Conference (AHAIC2023). IFPMA is proud to be a partner of AHAIC2023.

To follow the event live, please go to: https://2023conference.ahaic.org/177/participation_form

How does regulatory reliance work in practice? How can its implementation accelerate access to medicines for patients? To find out the answer to these & more questions, join us at #AHAIC2023! https://ahaic.org/ Share on X

 

Speakers

Jacqueline Acquah EMEA Vaccines Regulatory Affairs, J&J; Co-chair, IFPMA ARN

Jacqueline Acquah is a trained pharmacist with about fifteen years of experience in the pharmaceutical industry.

Jacqueline works with Johnson & Johnson as an associate director responsible for vaccines regulatory affairs in emerging markets in Europe, Middle East, and Africa (EMEA).

Part of her work is to prioritize and optimize regulatory strategy to potentiate access to vaccines in Africa, identify policy issues to shape the regulatory affairs landscape, and to work with other functions at regional level as well as with local regulatory affairs engagement teams in support of life cycle management and clinical trial activities.

She also currently serves as the Co-Chair for the Africa Regulatory Network (ARN) of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The association works in partnership with regulatory authorities and the pharmaceutical industry in Africa to encourage greater harmonization of regulatory requirements on the African continent. This partnership enables patients to gain access to good quality medicines, including innovative medicines and vaccines.

Jacqueline has supported Medicines Regulatory Harmonization across the subregion, through her representation of the IFPMA on the African Medicines Regulatory Harmonization Partnership Platform since 2018.

Chimwemwe Chamdimba Head of Health Programme, AUDA-NEPAD

Chimwemwe Chamdimba is the Head of Health Programme at the African Union Development Agency (AUDA-NEPAD). She responsible for the management of continental and regional health priority project including the African Medicines Regulatory Harmonization (AMRH) Programme. She is leading partner engagement towards African Medicines Regulatory Harmonization (AMRH) and support to the operationalization of the AMA. As a health policy specialist, she has spearheaded health policy and regulatory reforms, regional harmonization and partner coordination. Chimwemwe has contributed to key continental policy processes including the African Union Model Law on Medical Product Regulation; the Treaty for the establishment of the African Medicines Agency (AMA); the AU Private Sector Engagement in Health Framework; the Science, Technology and Innovation Strategy for Africa (STISA-2024); and African Union Health Strategy.

Asmaa Fouad EDA

Ms. Asmaa Fouad Ismail is currently General Manager of the Biological Products General Administration, the Central Administration of Biological and Innovative Products and Clinical Trials at EDA managing marketing authorization, lot release and laboratory evaluation, analysis & technical support of biological products.

Ms. Asmaa is delegate of EDA in ICH & IPRP.

Ms. Fouad is also a member of the Emergency Committee at EDA and has participated in the formulation of many national guidelines in Egypt. Ms. Fouad worked in the COVID-19 Vaccines Global Review team with the WHO. Ms. Fouad has 18 years of biological products regulatory experience.

Ms. Fouad obtained a BSc in Pharmacy from Cairo University & MBA from Arab academy of managerial, finance & banking sciences.

Dr George Kimathi Director, Amref ICD

Dr George Kimathi is the Director, Amref Institute of Capacity Development (ICD) and provides  overall leadership to Amref’s Human Resources for Health (HRH) agenda. In this role he oversees diverse initiatives geared towards building a fit-for-purpose health workforce across Africa.

He leads transformational human resources for health partnerships with WHO, Africa CDC, USAID, JICA, Gates and various private sector players among others. Further, he sits on the WHO HRH Leadership Hub of the Global Health Workforce Alliance, among others.

Dr David Mukanga Deputy Director Africa Regulatory Systems, Bill & Melinda Gates Foundation

Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports the development of harmonized, transparent, and predictable regulatory systems covering the lifecycle of medical products in Africa across the national, regional, and continental levels of the ecosystem. His work also involves support for regulatory emergency preparedness. 

Cynthia Olotch Board Member, IPOPI

Cynthia Olotch is a Board Member at the International Patient Organisation for Primary Immunodeficiencies (IPOPI), which is a non-profit international organisation that advocates for primary immunodeficiency (PID) patients worldwide.

She is also the founding member and current chairperson of a patient organisation in Kenya known as the Primary Immunodeficiencies Association of Kenya (PIDS-Kenya) and a member of Rare Disorders Kenya, which is the umbrella patient organisation for rare diseases in Kenya.

In addition to her role in the patient groups mentioned above, Cynthia works full time as a lawyer and is a partner at DLA Piper Africa, Kenya (IKM Advocates), in Nairobi.

Gabriela Zenhäusern Deputy Head Stakeholder Engagement, Swissmedic

Gabriela Zenhäusern joined the Stakeholder Engagement Division at Swissmedic, Switzerland in 2019. Gabriela Zenhäusern used to work in the sector authorization at Swissmedic, Switzerland from 2010 to 2015 before joining the Regulatory Systems Strengthening team (RSS) at WHO from 2015 to 2019.

Greg Perry (moderator) Assistant Director General, IFPMA

Greg is responsible for IFPMA’s Africa Engagement and Alliance Building strategies, focusing on innovation, access, and the regulatory environment. He has a long track record of leadership and advocacy in public healthcare and pharmaceuticals at international and European levels.

Before he joined IFPMA, Greg was Executive Director of the Geneva based Medicines Patent Pool.

Greg is a Member of the Advisory Council of the Organization for Professionals in Regulatory Affairs (TOPRA) and is a former member of the Standing Advisory Committee before the European Patent Office (SACEPO).

 

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