Mr. Udit Singh

/in /by

His primary role is to achieve the milestones set to meet the strategic vision and direction of the organisation. He has 18 years of expertise in anti-counterfeit packaging technology, global pharmaceutical Serialization, Supply chain traceability, Product Authentication and Quality Control for the pharmaceutical industry and strives to develop better technological practices in the sector. His mission is to enhance productivity and quality, ultimately providing end consumers and patients with better outcomes. His vision is for ACG to lead in the technology and solution space for the pharmaceutical industry beyond regulation, setting new benchmarks to make it better.

Dr. Ropafadzai Hove

/in /by

Ropafadzai Hove is a public health professional, with more than thirty years experience in medicines regulatory affairs and policy co-ordination at national, regional, and international levels.

 

As Chief Regulatory Officer at BoMRA, she provides technical and strategic direction to the Technical Teams in the regulation of medicines, medical devices, and cosmetics.

She chaired the Pharmaceutical Advisory Committee in the Southern African Development Community (SADC) resulting in the establishment of the SADC work sharing initiative for medicines regulators, ZaZiBoNa.

 

Ropah is a pharmacist, with a Masters of Science degree in Pharmaceutical Services and Medicines Control from Bradford University, United Kingdom.

DR. HAYTHEM SABRY

/in , /by

He graduated from the Faculty of Pharmacy in 2008, then he joined the marketing, sales and Business administration diploma at the American University in Cairo and the Naval Academy as well.

He started his career in the Egyptian Drug Authority (formerly the Ministry of Health and Population) in 2013 and worked gradually until he reached the Head of Digital Transformation in EDA.

His big focus was managing the track and trace project in Egypt from 2018 until 2020 adding to that he managed to transform the registration to be automatically and having company profile for each entity registering in EDA then he decided to move to GS1 Egypt, where he is responsible for helping in implementing the GS1 standards in the healthcare sector and continuing to manage track and trace and other projects such as the UDI project for medical supplies, which was implemented in Egypt in 2021-2022 and other projects related to the health care sector in Egypt.

DR. SAHAR EBRAHIM

/in /by

Dr. Sahar Ebrahim is a seasoned Public Health Physician with over 28 years of experience in the biopharmaceutical industry. She obtained her medical degree from Alexandria University and has since dedicated her career to clinical research. Currently serving as the Regional Head of Clinical Operations for the MENA region, Sahar is based in Egypt.

For the past 17 years, Dr. Sahar has been an invaluable member of Quintiles/IQVIA, where she has made significant contributions to the field. Her expertise extends across various regions, including Egypt, Levant, Gulf countries, and North Africa. As a certified Good Clinical Practice (GCP) trainer, Sahar has trained numerous professionals in the industry.

Throughout her career, Dr. Sahar has been involved in over 750 clinical trials, spanning phases I to IV, and has successfully recruited more than 55,000 subjects across 250 sites. She has collaborated closely with regulatory agencies in Arabic-speaking Middle Eastern and North African countries, conducting landscape assessments and benchmarking against more mature markets. Sahar has also organized regulatory workshops to share best practices and develop transformation roadmaps.

With an impressive track record, Sahar has conducted 80 site audits, 12 system audits, and 18 regulatory inspections. Additionally, she has played a pivotal role in streamlining business processes through strategic partnerships. Sahar’s contributions have been instrumental in supporting the expansion of a Prime and partner sites Network in the Middle East.

With her wealth of experience and deep understanding of the biopharmaceutical industry, Dr. Sahar Ebrahim continues to make significant strides in advancing clinical research and healthcare outcomes across the MENA region.

Dr. Hala Abu Ghazalah

/in /by

Hala Abu Ghazalah, Head of Regulatory Sciences, Africa & Middle East, Pfizer

Hala has over 25 years of experience in Pharmaceutical and Healthcare industries and had several leadership roles within Regulatory Affairs, External affairs, and Marketing

Pharmacist by education, licensed in both UAE and Canada

SAFA’ ABU GHARBIAH, PHD

/in /by

BSc in Pharmacy from Jordan University, 1991

MSc in drug analysis from Monastir University, Tunisia, 1998

PhD in Pharmaceutical sciences from University of Lille II, France, 2005. PhD thesis was awarded with distinction, and it was nominated for “State Prize” at the Pharmaceutical Academy in Paris.

 

I have been working in the pharmaceutical industry for around 30 years. Joined Hikma Pharmaceuticals in 1991 and worked in different technical departments, with many years of hands-on experience in the formulation and process development, as well as analytical development of oral and injectable generic products. I held the position of Technical Director in Medicef (a newly established sister company for Hikma in Tunisia) for seven years, where I established all the technical departments: QA, QC, Product Pipeline, technical transfer and Regulatory Affairs. I also headed the Research and Development – Injectables department in Amman for around 10 years and successfully developed and registered new generic products targeting global markets in USA, EU and MENA.

 

Currently, I am heading the Regulatory Affairs activities in the MENA region, contributing to the development of the Regulatory strategy as well as setting the required implementation plans and programs that ensure effective and efficient function’s performance to best serve business needs across the region; while overseeing the Regulatory Affairs operations considering compliance with the internal and external policies and legislations, including submissions of new products in the pipeline and the maintenance of the existing portfolio in more than 14 countries in the MENA region, with local regulatory affairs teams in the majority of these countries. Work closely with health authorities and work on shaping the regulatory environment through liaising with the local agencies, local pharmaceutical organizations and associations and other stakeholders.

 

Other Activities in the Educational Field:

Jordan University of Science and Technology-Deanship of Scientific Research:

  • Member in the “Scientific Research Committee” during the scholar year 2019-2020.

Yarmouk University:

  • Member in the Faculty of Pharmacy board during the scholar year 2018 – 2019.

Jordan University of Science and Technology (JUST) & Yarmouk University:

  • Deliver lectures to 5thyear Pharmacy students on the application of certain concepts and technologies in the pharmaceutical industry, focusing on bridging the gap between theorical knowledge and practical application (started in 2017 till now).

Jordanian Association for Pharmacists:

Received an appreciation and recognition award from the “Jordanian Association for Pharmacists” for the significant contribution to the development of pharmaceutical industry in Jordan (March 2019).

DR. AMIT N. THAKKER

/in /by

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.

MR. ABEBE ALAMNEH KASSAHUN

/in , /by

Abebe Alamneh Kassahun is a dedicated professional with a strong background in the field of medicine regulatory affairs. He holds a Bachelor’s degree in Pharmacy and a Master’s degree in Medicine Regulatory Affairs from Addis Ababa University.

 

Currently, Abebe serves as a Medicine Registration Expert at the Ethiopian Food and Drug Authority (EFDA), where he plays a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products in Ethiopia. With his expertise, he actively contributes to the regulatory processes involved in the registration and approval of medicines, ensuring compliance with national and international standards.

 

In addition to his role at EFDA, Abebe also holds the esteemed position of Vice Chairman at the East African Regulatory Affairs Professionals Association (EARAPA). As the Vice Chairman, he demonstrates exemplary leadership skills and actively participates in shaping the regulatory landscape within the East African region. Abebe collaborates with fellow professionals to develop harmonized regulatory frameworks, facilitate information exchange, and promote best practices in medicine regulation.

Dr. Neveen Kamel

/in /by

Neveen holds degree of Bachelor of Pharmacy – Faculty of Pharmacy – Cairo University. She is currently Head of Regulatory Affairs North Africa, Egypt  & Africa Developing Markets at Merck, supporting regulatory policy advocacy efforts for the region. She has over 20 years of experience in industry and 16 years of them as Regulatory Affairs, Prior to Regulatory Affairs she worked in several Multinational companies in different roles Commercial, Quality, Pharmacovigilance, Market Access & pricing. Neveen is also an active member of several trade associations including IFPMA Africa Regulatory Network (ARN); PhRMA Egypt Regulatory working Group; She participated in writing the Position paper for Registration Sampling & QC testing (IFPMA ARN)

DR. SYBIL NANA AMA OSSEI-AGYEMAN-YEBOAH

/in , /by

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.