Mr. Sidibé is a renowned tireless champion of African-owned solutions and has been an outspoken advocate for local pharmaceutical production of medicines and other essential health commodities. He contributed to the efforts towards access to quality and safe medicines and vaccines and in fighting global inequities.

In April 2021, he was appointed African Union Special Envoy for AMA. Thanks to his high-level advocacy efforts, the treaty entered into force on 5 November, much more quickly than expected.

A former Minister of Health and Social Affairs for Mali (2019-2020), Sidibé has championed a people centered approach to health and development for over 40 years.

He served as Executive Director of UNAIDS, holding the rank of Under-Secretary-General of the United Nations (2009-2019). Prior to joining UNAIDS, Mr. Sidibé worked at UNICEF and for Terre des Hommes, where his passion for advancing global health and social justice began.

Under his leadership at UNAIDS, more than 25 million people started life saving HIV treatment.

In 2021 he was appointed a board member of The Global Commission on Drug Policy.

An economist by training, Michel Hamala Mr. Sidibé is the recipient of various African and global awards, including honorary doctorates from world’s leading universities.

Samuel Asante-Boateng is a Ghanaian by birth and about 56 years of age. He is a professional pharmacist trained at the Kwame Nkrumah University of Science and Technology (KNUST) Ghana 30 years ago and has also done further studies in MSc Pharm. Technology at the University of Bradford in UK. He has taken certificate courses in leadership, management and administration at the Ghana Institute of management and Public Administration (GIMPA). He currently works with the FDA Ghana as the Head of the Drugs and Herbal medicine Registration Directorate. He has been working in regulation for the past 17years. Before joining the FDA, Samuel Asante-Boateng worked in the pharmaceutical industry in Ghana for 12years.

He is part of the team of assessors at the FDA Ghana for the past 14years and has also participated in a lot of foreign GMP inspections.

In support of the West Africa Medicine Regulation Harmonization (WA-MRH) project, Samuel has been working as the chairman of the Expert Working Group for Medical Product Dossier Evaluation and Registration (EWG-MPDER) involved in the Regional joint assessment procedure in the ECOWAS region since its commencement in the year 2017.

Margareth Ndomondo-Sigonda, works for AUDA-NEPAD as the Head of Programme. She is responsible for providing technical lead and strategic oversight on health and pharmaceutical programs such as the African Medicines Regulatory Harmonization (AMRH) Initiative, the establishment of African Medicines Agency as a specialized agency of the African Union (AU), and promotion of local production of pharmaceuticals in Africa.  She currently leads the regulatory workstream of the AU Partnerships for African Vaccines Manufacturing (PAVM) Framework.

She previously served as Chief Pharmacist and Registrar of Pharmacy Board of Tanzania (1998-2003) and as the first Director General of the Tanzania Food and Drugs Authority (2003-2010).

She holds a PhD in Pharmacology from the University of the Witwatersrand, Johannesburg, South Africa.

A Pharmacist with 33 years’ experience and 23 years’ experience as Pharmaceutical and Quality Assurance Analyst. She holds MSc. in Pharmaceutical and Quality Control (1999) from KNUST-Ghana and currently a PhD candidate in Public Health Administration and Policy. She is a Fellow of the West Africa Postgraduate College of Pharmacists (2018) as well as a Fellow Ghana Post Graduate College of Pharmacists (2016).

Sybil has been working with WAHO for the past 12 years as the Professional Officer in charge of Pharmaceuticals, and now the Ag. Principal Program Officer and Head of Public Health Division.  She has expertise in policy and strategic plan development, medicines regulatory systems, quality control systems for laboratories, ensuring the accreditations of the national regulatory agencies and laboratories to international standards, building local pharmaceutical manufacturing capacities and establishing good manufacturing practices. She has coordinated the ECOWAS Regional Medicines Regulatory Harmonization process since 2014, trained and developed regional experts in the pharmaceutical sectors to strengthen the human resource for the work force, as well as led various initiatives to improve access to quality, safe and affordable medical products in the ECOWAS region. Has good working relationships with stakeholders and partners. Currently coordinating the ECOWAS COVID-19 vaccines Taskforce to ensure effective access of COVID-19 vaccines and other vaccines production in the region.

Dr Manal Younus is currently the head of Iraqi Pharmacovigilance Center based in MOH. Manal is a pharmacist with a Ph.D. in Clinical Pharmacy. Key achievements include the establishment and the expansion of the Iraqi pharmacovigilance system. Represent Iraq in the WHO international drug monitoring program (PIDM). She is an International Society of Pharmacovigilance (ISoP) Advisory Board member  and represent ISoP in the Council of International Organizations of Medical Sciences (CIOMS). Manal is the vice president of the ISoP Middle East chapter,  ISoP Pharmacovigilance Professional Qualification Framework SIG member and she had authored more than 30 articles in different drug safety related subjects. Finally, a member of the specialized committee for Antimicrobial Resistance of the International Academy of Public Health (IAPH).

In addition to his current title, he is also the founding Deputy Director, and, in these roles, he has led the strategic work and oversight of Africa CDC. He works closely with African Union Member States and partners to deliver on the mandate of Africa CDC of preventing and controlling diseases in Africa.

Ahmed has led the operations of Africa CDC during the COVID-19 pandemic, coordinating the planning, acquisition, and delivery of life-saving health products to African countries including test kits, personal protective materials, therapeutics, and vaccines. Formerly, he worked with the WHO at both the HQs and Regional Office for Africa, in combating NCDs & tobacco control.

Prior to that, Dr. Ahmed worked at country level in the Ministry of Health, Kenya, as Director for NCDs and then Head of the Office for International Health Relations. He has been at the forefront of advocacy and action to reform the health system in Africa including the need to establish an efficient & effective response mechanism for disease threats and health emergencies. He has over 25 years’ experience in public health and is an alumnus of the University of Nairobi in Kenya and the University of Bergen in Norway.

S/Directrice de l’Homologation des Médicaments et des Autres Produits Pharmaceutiques – AIRP

Membre de la Commission Nationale du Médicament et des autres Produits Pharmaceutiques (CNMPP) représentant l’AIRP

Membre du comité des experts pour l’évaluation technique des demandes d’homologation

Pharmacien inspecteur assermenté au sein de l’AIRP depuis Juin 2022

Experte en Affaires règlementaires avec plus de 15 ans d’expérience dans l’Industrie Pharmaceutique

Membre fondateur de l’ARAF (Association des Règlementaires de l’Afrique Francophone) créé en 2009

Ancien membre des GTT organisés par le LEEM.

Dr. Janet Byaruhanga is a qualified medical doctor and public health expert that obtained her postgraduate diploma in public health research from the University of Edinburgh and has over 14 years of experience in international development with special focus in human and social sectors. Served as health policy officer at the African Union Commission since 2007 where she provided technical leadership and oversight in development and delivery of key strategic continental policy frameworks, programmes and initiatives geared towards strengthening the continent’s healthcare delivery system, food security and nutrition, and promoting the social well-being and rights of women and children.

Dr. Byaruhanga since 1st September 2017 joined the African Union Development Agency- NEPAD as a Senior Programme Officer-Health. She is in charge of coordinating and facilitating development and implementation of policies on health and medical products and ensuring their alignment with industrial development; trade; science, technology and innovation polices in advancement of the African Union’s African Health Strategy and the Pharmaceutical Manufacturing Plan for Africa (PMPA).

She is a registered pharmacist with an MSc in Pharmaceutics (Bioavailability). After spending 22 years in the pharmaceutical industry in regulatory affairs, quality assurance and pharmacovigilance roles with companies such as Merck KGaA, Boehringer Ingelheim and Merck Sharp & Dohme, she joined the South African Medicines Regulator, SAHPRA, in June 2020 to head up the organisation’s Backlog Clearance Programme. When SAHPRA was established in 2018, it inherited approx. 16,000 in-process applications from its predecessor, the Medicine Control Council.

A dedicated Programme was set up to clear the application backlog and, to date, the backlog is 99% finalised due to the various initiatives piloted and implemented within the project.

Bio:

• Passionate about Health Products Regulation
• Access to Safe, Quality & Efficacious Health Products
• Motivated by success
• Favorites: Music, Fitness, Travelling, Sport

Career:

• Pharm (Hons), PG DiP Medicines Development & MBA
• Senior Manager at SAHPRA since Jan 2021
• Regulatory Officer/ Assessor at MCAZ (2.5 yrs.)
• Regulatory Affairs in Pharma (6.5 yrs.) & FMCG (1.5yrs)
• 5 years’ experience in R&D

Florah is a pharmacist by profession currently heading the pharmacovigilance unit of South African Health Products Regulatory Authority (SAHPRA). She holds BPharm and master’s in pharmacy with specialisation in Pharmacovigilance & Pharmacoepidemiology. She joined SAHPRA in 2011 as Medicine Registration Officer in the Pharmaceutical & Analytical Directorate and later Head the Vigilance unit since October 2015 to date. She has experience in different pharmacy sectors, including medicines regulation, retail and hospital pharmacy. She has attended different pharmacovigilance courses offered internationally including training by Uppsala Monitoring Centre.

She supports the National Immunisation Safety Expert Committee and member of African Union Smart Safety Surveillance (AU-3S) Joint Signal Management Group, aimed at facilitating cross-country signal management for COVID-19 vaccines in Africa, to support action in the interest of public health and safety.

She is the Head of Regulatory Compliance at the South African Health Products Regulatory Authority (SAHPRA). She’s a pharmacist with over 20 years of experience in various sectors of Pharmacy within South Africa from clinical, drug utilisation review, regulatory and policy making. Qualifications are B. Pharm, MSc in Pharmacy and MBA from the University of the Witwatersrand.

She manages the activities of market surveillance and control function of medicines and medical devices in terms of the Medicines and Related Substances Act, 101 of 1965. This includes control of import activities; market surveillance program for monitoring the quality of medical products throughout the supply chain prevention; detection of and response to substandard and falsified medical products; control of promotional, marketing and advertising activities.

Her duties also include managing activities relating to consumption and reporting consumption (manufacture, import, export, distribution, possession and use) of narcotics and psychotropic substances to UN’s International Narcotics Control Board (INCB) in terms of the Conventions requirements. This includes supervision of activities relating to licensing, medical and scientific cannabis and she also represents the organisation in this regard.

Additional roles includes leadership coaching: Wits MBA students and she’s an ad hoc external examiner and assessor of postgrad pharmaceutical education qualifications/programmes.

2006:Diplôme National en pharmacie

Faculté de Pharmacie de Monastir-Tunisie

2014:Diplôme National de Docteur en Pharmacie

Faculté de Pharmacie de Monastir. Tunisie

2017:Mastère Professionnel de Management de la qualité dans ledomaine de la Santé.

Faculté de Pharmacie de Monastir. Tunisie

2019-2020 : CEC Pharmaco-économie et Market Access :

Faculté de Pharmacie de Monastir. Tunisie

2021: Certificate: « Project management in Global health »

Certificate: « Leadership and management in health »

University of Washington-USA/Polygone Learning El Kram Tunisie

2022: Certificate: « Project Management in HIV »

University of Washington-USA/Polygone Learning El Kram Tunisie

EXPERIENCES PROFESSIONNELLES

2008-2013 : Officine Privée à la Marsa-Tunisie

Poste occupé : Pharmacien assistant

Missions :

• Gestion d’une officine privée : (préparations officinales, dispensation des médicaments, gestion de stock, conseil en officine)

2013-Présent :Direction de la Pharmacie et du Médicament : Ministère de la Santé-Tunisie

Poste occupé : Pharmacien Principal de la santé Publique et chef de service de l’enregistrement des produits pharmaceutiques locaux

Missions :

• Enregistrement des médicaments humains
• Coordination du plan d’action National de lutte contre la résistance aux antimicrobiens

He graduated from Doctor of Pharmacy (MCPHS University, USA).

After graduating he worked as a clinical pharmacist, owned, and ran a pharmacy, co-founded a Silicon Valley healthcare technology company, and ran a preventive healthcare company. Dr. Lucas is a co-patent holder for a neuropathic pain product. He is a certified pharmacogenetics/ pharmacogenomics pharmacist, Certified Immunization pharmacist since 2009, Certified Medication Therapy Management, among other.

His professional passions are:

1. The provision, of Appropriate, Effective, Efficient and Safe pharmaceutical care…
2. The recognition of the crucial and important role of pharmaceutical care to healthcare and economic productivity
3. The reimbursement of cognitive pharmaceutical care services offered by pharmacist…
4. The acknowledgement that Health Products and Technologies are pharmacist’s tools to achieve positive patient Outcome and as such we need to be heavily involved in ensuring quality…
5. The capacity building of the pharmaceutical care service force

He serves as co-founder and Director at NewSpring Foundation that supports bright kids from Kibera. He is a Rotarian of the Rotary Club of Nairobi. His hobbies include Soccer Golf, Cycling, CrossFit and coaching his son soccer team.

External Medicine Dossier Assessor at Ethiopian Food and Drug Authority (EFDA) and

the Co-founder & Vice President of East Africa Regulatory Affairs Professionals Association (EARAPA). Mr. Nathan is also an assistant lecturer at the Addis Ababa University, School of Pharmacy, Department of Social Pharmacy and Pharmaceutics, Medicine Regulatory Affairs program.

He graduated from Clinical Pharmacy at the Addis Ababa University, and he’s currently finalizing his Master’s Degree in Medicine Regulatory Affairs.

I am an academician at the School of Pharmacy, in the Department of Pharmaceutics and Social Pharmacy.

Max Goldberg leads the global medical device reporting team for Worldwide Patient Safety at BMS. He holds a bachelors and master’s degree in engineering and has expertise in medical devices and combination products throughout the entire product lifecycle. Max has been involved in product development, risk management, manufacturing, and post market surveillance for medical devices, combination products, and biologics. He is involved in forming and implementing global combination product post market safety reporting regulation.

Drug Registration Officer at the Tanzania Medicines and Medical Devices Authority (TMDA)

I work as a Drug Registration Officer at the Tanzania Medicines and Medical Devices Authority (TMDA) where I am involved in the evaluation of medicinal products dossiers.  Within TMDA, I have been the focal person for the SADC Medicines Regulatory Harmonization Programme (SADC MRH) for the past two years. Under the this Programme I have participated in many activities and initiatives to include co-chairing the SADC Variations Technical Working Group, and currently serving as a member to the current Technical Working Group (TWG) responsible for developing SADC Emergency Use Authorization Framework under the support of the German Federal Institute for Drugs and Medical Devices.

I am currently the Focal Person and the Regional Technical Officer for the East African Community Medicines Regulatory Harmonization Programme where I coordinate all matters related to EAC joint activities including assessment of dossiers and quality assurance of reports as well as a serving as a member of the Expert Working Group on Medicines Evaluation and Registration of the Programme.

She is an American board certified for pharmacotherapy specialty, she has two master degrees, one in clinical. pharmacotherapy and the second in public Administration from the American University in Cairo.

She is a fellow at the Egyptian board for healthcare management. She has profound working history in regulating pharmaceutical practices in the Egyptian public and private sectors, she used to be managing the PV General administration for more than 2 years, supporting the additionally, she represents the Egyptian drug authority as an Observer at the international cooperation on cosmetic regulations working group ICCR. Previously, she used to be the antimicrobial stewardship national coordinator and participated in the development of the National Action Plan for Antimicrobial Resistance.

Mr HONORE AYINKAMIYE is a Pharmacist with experience of more than 10 years in the pharmaceutical sector, both in private and public institutions, where he has been involved in technical and managerial positions. Currently, he is working with Rwanda Food and Drugs Authority (Rwanda FDA) as a Finished and Active Pharmaceutical Products Registration Specialist.

HONORE has been involved in different regulatory activities at the country level and he is also contributing to the Medicines Regulatory Harmonization initiatives as the assessor of product dossier applications at the East African Community (EAC) level to insure the products’ quality, safety and efficacy.

He is also the Focal Person for the WHO/SRA Collaborative Registration Procedures (CRP), a facilitated procedure that aims to accelerate the registration process through improved information sharing between WHO PQ and national regulatory authorities (NRAs).

HONORE is passionate about ensuring equitable access to safe, efficacious and quality health commodities.

Currently Executive Director of Zanzibar Food and Drug Agency (ZFDA). Over 20 years’ experience in strengthening Zanzibar Medicine Regulatory Authority from less resourced Pharmacy Board to the middle-income Food and Drug Agency.

He Participated in WHO assessment of Medicine Regulatory System in Sub Saharan African Countries, Devoted, Pioneering and Volunteering in Regional Medicine Regulatory Harmonization Initiatives and African Union Medicine, Policy and Regulation Reforms Expert Working Groups.

Dr. Peter Mbwiiri Ikamati is a Medicines Evaluation & Registration expert at Pharmacy and Poisons Board (PPB, Kenya) and EAC MRH programme (Assessment). He is the current Chief Principal Regulatory officer, Product Evaluation and Registration and has been overseeing all the PPB regulatory functions (on behalf of the Chief Executive Officer) towards achieving WHO Maturity Level 3 from May 2021. He has interest in research and has published work on analytical methods development and development of microspheric systems for drug delivery. Dr Mbwiiri additionally has interest in clinical trials regulations.

Dr. Mbwiiri earned his Bachelor of Pharmacy degree from the University of Nairobi in 2000. He holds a master’s degree in pharmaceutical sciences with Management Studies from the Kingston University in London and a doctorate in Health Sciences (Targeted drug delivery systems) from the Aston University, UK.  He is an associate fellow of Higher Education (UK).

Dr. Mbwiiri started work at Ministry of Health as a Hospital Pharmacist and held various capacities upto the year 2005 when he joined the Pharmacy and Poisons Board (PPB; the National Medicines Regulatory Authority, Kenya). At Mbagathi district hospital, where he had risen to superintendent Pharmacist, he was part of the team that initiated piloting of HAART (Highly Active Anti-retroviral Therapy) programme that allowed for provision of antiretrovirals in public hospitals in Kenya.

Dr. Mbwiiri has a wealth of regulatory experience having served in various capacities within the Pharmacy and Poisons Board. He has been instrumental in initiating reforms on medicines evaluation and registration at the Pharmacy and Poisons Board (Kenya) and regionally (at East Africa Community (EAC) and Intergovernmental Authority on Development (IGAD).

Dr. Mbwiiri is also a consultant with World Health Organization Prequalification Team (formerly WHO Prequalification programme).

Farai joined the MCAZ in 2011 and has been involved in regulatory affairs for over 10 years.

He has been involved with the ZAZIBONA collaboration since its inception in 2013.

Farai has coordinated the ZAZIBONA dossier assessment activities since 2015.

A visionary entrepreneur and an industry captain, Dr. Amit N. Thakker, has been a ground-breaking pioneer in the integration of private sector within the healthcare system in Africa. Dr Thakker actively supports governments, corporates, health organizations and development partners to foster effective public private partnership initiatives towards improved health outcomes.

He is the executive chairman of Africa Health Business, a health consultancy, advisory and investment firm that aims to improve access to quality affordable healthcare in Africa. He is also the president of Africa Healthcare Federation, chairperson of the Kenya Health Professionals Oversight Authority, and the former chairman of Kenya Healthcare Federation.

He has served as a director at LumiraDx, Seven Seas Technology, AMREF Flying Doctors. Action Aid and Ghanima Limited. As an active member of several institutions including international business group YPO Gold (Nairobi Chapter), Dr. Thakker also chairs the University of Nairobi Alumni Medical Chapter and serves as an advisor to Asia Africa Investing & Consulting Ltd, Coalition for Blood in Africa (CoBA) and Ministry of Health, Kenya.

Dr. Thakker founded Avenue Healthcare, a Kenyan based integrated private health service provider in 1995 which lead him to receive the “Best Male Entrepreneur of the Year” award by Rotary International in 1999. He also won the “Best CEO” award by Titans Global in the Business and Professional services category in 2017 and proudly received the Chairman’s Award for Kenya Medical Association in 2004.

Lenias Hwenda is the Founder and CEO of Medicines for Africa, a social enterprise that improves access to treatment. She is a recognized influential thought leader and practitioner who continues to contribute at the highest stage of international health affairs working with African governments in the World Health Organization for more than a decade. She has participated in and led a number of intergovernmental and industry negotiations seeking the best solutions to meet the health needs of vulnerable people around the world. Lenias recently co-chaired the historic World Health Organization negotiations between governments on improving the transparency of markets for medicines, vaccines, and other health products during the World Health Assembly in 2019. She is a tireless advocate using her deep knowledge of public health, international affairs and health security to drive initiatives that improve access to healthcare by underserved communities. She hosts “Let´s Talk about health in Africa” Podcast conversations highlighting challenges and opportunities for improving the health of Africans.

Nevena Miletic is a Regulatory and Policy professional, passionate about bringing innovative therapeutic solutions to patients in need around the world.

She is a pharmacist, with postgraduate studies in Pharmacoeconomics, regulatory affairs and quality assurance, and a certified QP, with almost twenty years of experience in pharmaceutical industry.

Currently she works in the Global Regulatory Policy group in F. Hoffmann-La Roche, Switzerland, and for the last six years, she is chairing IFPMA Africa Regulatory Network and IFPMA CPP Network.

She is also a member of research-based pharmaceutical companies associations and boards (IFPMA Regulatory Science Committee, IFPMA Africa Engagement Committee, DIA Middle East & Africa Advisory Board, EFPIA ERAO, IATF etc.), involved in numerous meetings, workshops and projects with regulators, cross-industry and public-private collaborative platforms (e.g. Pre-ICDRA, ICDRA, SCoMRA, IMI/IHI etc.).

Ms. Miletic is strong advocate for regulatory convergence and harmonization, as well as for modernization of regulatory frameworks to enable innovative approaches in drug development and review.

She is a pharmacist by training. She has specialized in Pharmacoepidemiology and Pharmacovigilance, currently enrolled for PHD studies in Clinical Pharmacology and Pharmacovigilance at Karolinska Institutet in Sweden focusing on strengthening safety monitoring in public health programs with a focus on mass drug administration.

She is the Head of Pharmacovigilance at the Pharmacy and Poisons Board, Kenya, and the Vice President of International Society of Pharmacovigilance, Africa Chapter. She has 15 years working experience in Pharmacovigilance related work and is responsible for leading the PV team in Kenya to develop regulatory systems to strength Pharmacovigilance within the health sector and pharmaceutical industry.

She is a member of the Pharmacovigilance and PMS technical working groups in Kenya, within the East African Community and The Intergovernmental Authority on Development Regional Economic Blocks and has contributed to development of various tools and guidelines for strengthening of PV in the region. Recently appointed as a member of the AMRH Technical Committee on Regulatory Capacity Development in Africa (ToR RCD)

She is passionate about patient safety and keen on strengthening pharmacovigilance systems and patients’ contribution to safety monitoring of medical products and health technologies, she is also keen in contributing to a pool of trained PV specialists in Kenya and gives honorary lecturers to both undergraduate and masters students at University of Nairobi.

My current title is EMEA RA Lifecycle manager at Janssen. I am handling lifecycle management activities for the Pharma portfolio for countries in the Non-European Economic area region (includes Africa).

I have 10 years of Regulatory experience in different Regional/Global roles from 4 different pharma companies like Pfizer, GSK, Amgen and Janssen. I keep it brief, but please let me know if you want more details.

• Depuis 2017 : Pharmacienne de santé publique  à la Direction de la Pharmacie et du Médicament (DPM) chargée de :

• La réception et l’évaluation des dossiers d’Autorisation de Mise sur le Marché (AMM)
• La participation aux travaux des commissions spécialisées (Neurologie, Psychiatrie, Ophtalmologie, Dermatologie, …) et la Commission d’Achat des Médicaments (CAM) à la Pharmacie Centrale de Tunisie (PCT).
• La validation des bons de commandes fermes (ATU)
• Suivi de la pénurie des médicaments

• 2013-2017: Pharmacienne assistante  en officine privée.
• Octobre 2012-Septembre 2017: Pharmacienne formatrice à l’Institut Tunisien de Santé

• 2012: Préparation de thèse de doctorat en Pharmacie (Recherche à l’Institut Pasteur de Tunis : Laboratoire Parasitologie et Immunologie)

• Septembre -Novembre 2011 : Stage officinal au sein d’une Officine privée «  Pharmacie Hattab Naouar Nouvelle Médina»: Dispensation de médicaments, Conseils, Préparations officinales, Préparations magistrales, Gestion officinale…

• Décembre- Février 2012 : Stage en biologie clinique au sein de laboratoire de Biochimie et de Toxicologie de Centre Hospitalo-Universitaire la Rabta Tunis
• Septembre 2009 – Février 2010 :

• Stage de 1 mois en Pharmacie hospitalière à l’EPS Aziza Othmana Tunis: pharmacie interne, pharmacie externe, préparatoire, dépôt des médicaments et dépôt des dispositifs médicaux.
• Stage de 5 mois d’Initiation à la Pharmacie clinique au Centre Hospitalo- à l’EPS Aziza Othmana Tunis: Service hématologie.

• Juin- Juillet 2005 :

• Stage d’Initiation aux soins infirmiers au service de maternité/Gynécologie de l’Hôpital Régional de
• Stage au sein de la pharmacie de l’Hôpital Régional de

• Juin 2004 : Stage d’Initiation à la pratique officinale au sein  d’une Officine privée  «  Pharmacie Hattab Naouar Nouvelle Médina»: Dispensation de médicaments, Conseils, Préparations officinales, Préparations magistrales, Gestion officinale…

COMPETENCES

• Maîtrise des  Préparations hospitalières et officinales.
• Maîtrise des  Préparations Magistrales.
• Maîtrise des  logiciels de bureautique : Word, Excel, Power Point …
• Permis de conduire

LANGUES

• Français : lu, écrit et parlé
• Anglais : lu, écrit et parlé
• Arabe : langue maternelle
• Allemand : lu et écrit

DIVERS

• SPORT
• LECTURE
• VOYAGE

Pr Nadjat LOUMI-MEDEDJEL, Director of the Centre National de Pharmacovigilance et de Materiovigilance (CNPM), is a doctor graduated from the University of Algiers, holding a Diploma of Advanced Studies from the Faculty of Medicine of Paris (France), a university degree in pharmacovigilance from the university Claude Bernard of Lyon and a doctoral thesis in clinical pharmacology at the Faculty of Medicine of Besançon (France).

She took part in the creation of the CNPM with its founder Professor A Helali in 1998, whereshe has always been devoted to pharmacovigilance and materiovigilance.

Since 2016, she has introduced the concept of Phytovigilance, Réactovigilance, Cosmetovigilance, in addition to the vigilance of the drug, the medicaldevice and the vaccine alreadyestablished.

Teacherat the Faculty of Medicine of Algiers, wheresheteaches the module of pharmacology. She supervises the training of resident physicians in clinical pharmacology.

She supervises also the training of health professional in :

“Pharmacovigilance and Materiovigilance” ; “Medical good prescribing” ; “Monitoring plasmatic of medicine” ; “Rational drug use program”.

She is Editor of the independent Medical journal “la Revue Prescrire” since 2007.

Kate Kikule is the Principal Technical Advisor for the pharmaceutical regulatory systems portfolio under the Medicines, Technologies and Pharmaceutical Services (MTaPS) initiative of the Medicines Sciences for Health (MSH), with expertise in regulation of medicines and health technologies. Kikule supports country programs by providing technical assistance to strengthen medicine regulatory functions, including medicine registration, regulatory inspections, licensing of premises, market surveillance, and pharmacovigilance. She also provides technical guidance for the development and implementation of policies, regulations, guidelines, and tools for strong and effective pharmaceutical regulatory systems. She is an experienced public health professional and pharmacist with more 20 years of experience in medicine regulation in emerging and low- and middle-income countries across Africa, Asia, and Europe. Kikule holds a Bachelor of Pharmacy (Hons) from the University of Dar-es- Salaam, United Republic of Tanzania, and an MPH specializing in health economics from the University of Capetown, South Africa.

George is a pharmacist by profession and had a Master degree in Public Health from the University of Ghana and a certificate in Pharmacovigilance and Pharmacoepidemiology from London School of Hygiene and Tropical Medicine. He is currently a PhD candidate at the University of Groningen where his thesis is focused on patients’ contribution to pharmacovigilance in Sub-Saharan Africa.

He is a Chief Regulatory Officer and the Head of the Safety Monitoring Department at the Food and Drugs Authority.

He has authored several abstracts and original research articles on medicine safety in peer reviewed journals.

George’s interest is in strengthening pharmacovigilance systems and patients’ contribution to safety monitoring of medicines and other health products.

Santosh Balbhadra Trivedi has a Bachelor of Engineering (Chemical) degree from G H Patel College of Engineering and Technology, Vallabh Vidyanagar, Gujarat, India, where he studied from 1998 to 2002. He has almost 20 years of overall experience and has worked in the Pharma & Life Sciences industry vertical for over 12 years in various roles from a Developer to Business Analyst, Product Owner, Serialization and Track & Trace expert, etc.

His current role since Feb-2022 is with Honeywell as the Senior Product Manager – Track & Trace facilitating governments/customers implementing Serialization and Track & Trace solutions to adhere to/implement the legal regulation requirements and/or to implement the value added solutions to improvise the supply chain visibility and integrity.

Brève présentation : Pharmacien, marié et père de trois enfants. J’ai treize (15) ans d’expérience professionnelle dont dix (10) ans dans le domaine de la réglementation et de la régulation pharmaceutique. Je suis dans l’amélioration continue du travail et j’ai une bonne capacité d’adaptation. Mes objectifs professionnels : Acquerir une excellente compétence dans la régulation pharmaceutique et Partager ces connaissances acquises en tant qu’expert.

Ashifi founded Sproxil® in 2009 and currently serves as the company’s Chief Executive Officer. Under his leadership, Sproxil developed its award-winning solutions that have been used on over 2.5 billion product units available to consumers in 6 countries to verify the authenticity of their products and earn instant rewards for their loyalty.

In 2015, Ashifi was named to Fortune’s 40 under 40 list. He was awarded the Social Entrepreneur of the Year award in 2014 by the Schwab Foundation and joined the Fast Company Most Creative People in Business 1000 community. In 2013, Sproxil was named the world’s most innovative company in health care by Fast Company, and #7 most innovative worldwide, beating 99 of the Fortune 100 companies. Most recently, he has been picked as a finalist for the 2020 Global Business Hall of Fame presented by JA Worldwide.

Ashifi served on the World Economic Forum’s Global Agenda Council on Social Innovation and on the Meta-Council on the Illicit Economy. He holds a US Patent and earned a Ph.D. in Engineering from Dartmouth College, where he delivered the 2020 alumni remarks at Investiture. Ashifi holds a B.A. in Mathematics and Physics from Whitman College. He was Whitman’s 2018 commencement speaker and received an honorary doctorate. He is Dartmouth’s first-ever Ph.D. Innovation Fellow and teaches an executive seminar and a course in New Business Ventures Technology Management at Columbia University.

Ashifi volunteers for the Whitman College President’s Advisory Board and the Board of Advisors at Dartmouth’s Thayer School of Engineering.

Dr. Amira Amin received her Bachelor degree of pharmaceutical science. faculty of pharmacy, Cairo University in 2006 and Diploma in clinical pharmacy from faculty of pharmacy (Ain-Shams university) in 2010.

Today she is the deputy head of Egyptian pharmaceutical vigilance administration at Egyptian Drug Authority since September 2020 and joined from pharmacovigilance specialist at Egyptian pharmacovigilance center (EPVC) – (CAPA) – Ministry of health (MOH) where she honed her skills for 6 years.

Tshepiso has assumed a role of a Clinical Operations Manager within one of the rapidly growing CRO organizations, Tigermed. She has prior experience as Head of Clinical Monitoring at one of the leading pharmaceutical companies, GSK.

Previously gained experience as a Local Study Manager, CRA, Study Coordinator.

In her recent clinical research journey and different roles, she gained experience in providing leadership, cultivating good relationships with internal and external stakeholders. Tshepiso is committed in delivering what is expected of her with integrity: by being dependable, accountable, with primary focus on doing what is right and of high quality.

Greg Perry joined IFPMA on 1st February 2018 and has responsibility for IFPMA’s external outreach and stakeholder engagement in global health topics including innovation, access, and the international regulatory environment. Greg Perry brought with him more than 20 years’ leadership and advocacy experience in the public healthcare arena.

Prior to joining IFPMA, Greg worked as Executive Director of the Medicines Patent Pool, which he joined in 2013 and as Director General of the European Generic Medicines Association (1999 – 2013) in Brussels. Previously he worked as a partner in a UK public affairs company as a European Union policy advisor to corporate and non-governmental organizations, and before that as a Parliamentary Advisor to Members of the European Parliament. 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). Greg also holds the Golden Cross of Merit of the Republic of Poland.

Inas is a holder of Pharmacy diploma, and Master in EU and International Regulations and Healthcare Laws from Paris V University.  Inas has 18 years expertise in the European and Emergent markets regulations; she worked for various MNCs, and currently she is heading the Regulatory and Policy departments for MEA region in Novartis.

Her focus and interest are the Healthcare reforms and legislations, policy shaping with main objective to accelerate patient access to innovative medicines.

Inas chaired the EFPIA regulatory group for 3 years; And she chaired the PhRMA association regulatory group for 4 years. She also chaired the program committee for the Middle East regulatory conference in 2019, and actively participating as a speaker in regional and international conferences.

He has more than 7 years of consulting experience within a variety of industries including, Financial Services, Energy and Resources and Life Sciences and Health Care. Prior to joining Deloitte, Mitesh gained 4 years of clinical experience as a Physiotherapist. His recent focus areas have been Data Strategy, Data Management, Data Privacy and Insights Driven Organisation.

Sisay Endale Biru is an academician and researcher at Addis Ababa University, College of Health Sciences, School of Pharmacy, Ethiopia. He completed his Bachelor of Pharmacy from Addis Ababa University and Master of Sciences in Regulatory Affairs (Medicine Regulation Track) from the same university.

He also graduated from Admas University with a bachelor’s degree in Marketing Management. He is currently engaged in research, teaching, and advising. He is the coordinator of Pharmacovigilance (PV) at the Tikur Anbessa Specialized Hospital’s PV center in Addis Ababa, Ethiopia. He works with the Ethiopian Pharmaceutical Association as a trainer, PV course lead, and CPD course evaluator.

Additionally, he actively contributes to the development of policy, research, the development of PV training materials, and the assessment of medication dossiers for the Ethiopian Food and Drug Authority (EFDA). His research interests include health and drug policy analysis, drug regulation, and drug safety (PV).