MR. JOHN MWANGI

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John currently works at Bayer as Head of Regulatory Affairs responsible for East & West Central Africa Region based in Kenya, responsible for Pharmaceuticals and Consumer Health divisions and doubling up as Regulatory Policy & Intelligence Lead for EEMEA Region.  He has previously held different roles in Pharmacovigilance and Quality Control within the Pharmaceutical Industry. He has been an active member of several industry associations including KAPI (Kenya Association of Pharmaceutical Industry) where he has served as member since 2013 including as past executive secretary and continues to serve in in various committees within KAPI and as Board Member.

John is passionate about supporting the streamline of Pharmaceutical Regulatory Systems & Policy and is currently a member of the Africa Regulatory Network (ARN) within the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) where he is the immediate past co-chair. Additionally, John represents Bayer in the Africa Engagement Committee of the IFPMA and is currently a member of the Africa Strategy for the Global Self Care Federation (GSCF).

MR. ALEX JUMA ISMAIL

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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.

MR. HONORE AYINKAMIYE

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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.

 

DR. SYBIL NANA AMA OSSEI-AGYEMAN-YEBOAH

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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. BURHANI OTHMAN SIMAI

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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.

MR. KUDAAKWASHE KAPFUMVUTI

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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

MS. NURAN IDRIS

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Nuran Idris joined GS1 Global Office in January 2020. She works in the Healthcare team as Healthcare manager for Africa. She is based in Nairobi, Kenya and is originally from neighboring Tanzania.

 

Nuran’s main role at GS1 is to support countries in Africa in establishing pharmaceutical traceability systems using GS1 standards.

 

Prior to joining GS1, she worked for multiple USAID funded projects in Tanzania and Malawi with short term engagements in Zambia and Ivory Coast. Nuran also briefly worked for one of Global Fund’s project in The Netherlands.

 

Nuran’s experiences have seen her engage multiple stakeholders from the grass root level up to senior levels in local and international settings. From the digital health angle, Nuran has conducted trainings and managed teams that deployed systems that have contributed positively to improvements in local supply chain operations.

 

With the power of standards, Nuran strongly believes that even more efficiencies and mostly, improved care to patients can be achieved in developing countries.

 

Nuran is a Political Scientist and a global eHealth specialist by training.

 

MR. STAVROS NICOLAOU

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Stavros Nicolaou is the Aspen Pharmacare Group’s Senior Executive responsible for Strategic Trade Development. Previously he was CEO of Aspen’s Export Business. Aspen is Africa’s largest pharmaceutical manufacturer and a now world leader in Anaesthetics and injectable anti-coagulants. Aspen is one of South Africa’s most globalised multinational companies with a presence in over 50 geographies globally, with 26 manufacturing facilities across 6 continents. He was instrumental in introducing the first generic ARV’s on the African Continent developed by Aspen, which has gone on to save hundreds of thousands of lives in South Africa and on the African Continent.

Nicolaou has over 30 years’ experience in the South African and International Pharmaceutical Industry and is a previous winner of the SA Institute of Marketing Management (IMM) Health Care Marketer of the year Award. He was a previous recipient Monty Rubenstein Award for proficiency in Pharmaceutics from the Wits University Pharmacy Faculty. He was awarded, the Order of the Lion of St Mark by the Greek Orthodox Pope Theodoros II and recently received the title of “High Commander of the Order of the Apostle & Evangelist Mark” of the Patriarchate of Alexandria.  He has been inducted as a Fellow of the Pharmaceutical Society of South Africa (PSSA), one of the highest honours bestowed by the PSSA, and was recently awarded an Honorary Doctorate in Medicine from Wits University.

He has been a speaker at a number of conferences, including the Economist Roundtable, the World Economic Forum (WEF) and recently delivered a lecture on ARV developments at the Raigon Institute, a JV between Harvard Medical School and the Massachusetts General Hospital.

He has previously and continues to serve on a number of Industry & associated structures, some of which include

MR. NATHAN SEYOUM

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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.

MR. EMEKA CHUKWURAH

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Emeka Chukwurah currently leads the Regulatory Affairs Projects Team at CQRAFF Solutions Ltd. His focus is in simplifying regulatory complexities in West African countries for business growth by creatively interpreting and influencing regulations, bridging knowledge gaps and relationship building between Regulators and the industry. He understands the thinking of regulatory authorities and the regulatory challenges facing businesses in West African markets.

 

In his current role he advises clients on: Regulatory Strategy for Market access / entry. Regulatory Submissions and Intelligence, Marketing Authorization applications and Post Marketing maintenance, Product Registration and License Management, Site cGMP Inspection Readiness, regulatory audit support services for manufacturing facilities and any other regulatory activity that may arise.

 

CQRAFF Solutions is a company incorporated by law in Nigeria to render Corporate Regulatory Affairs services to Cosmetics, Pharmaceuticals, Medical Devices & Diagnostics, Food & Nutraceuticals companies/manufacturers with strong presence in Nigeria and Ghana.