Dr. Yasmine Maher El-Shebiny

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Regulatory Affairs expert with 14 years of solid Regulatory Affairs background in the pharmaceutical industry.

 

Profile and Areas of Expertise:

 

Experienced in developing different regulatory strategies in-line with business needs, leading registration, and lifecycle maintenance plans. In addition to safety management, compliance, SOPs design and audit readiness. Managed different lifecycle stages of an organization (merger, integration, and spin-off).

 

Drive interactions with Health Authorities, influence regulatory reforms and shape the external regulatory environment and health care policies.

 

Aspired to drive processes enhancements (Lean Six Sigma green belt certified). Have led and been a team member of different successful cross-functional projects including but not limited to New Product Launches, CMC and Ancillary component management, Safety management and Digital transformation in pharmaceutical industry.

 

Respect and leverage human capital – Motivate, coach, mentor and lead talented professionals helping teams to reach high integrated performance.

 

 

DR. HEBA NABIL

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She graduated in the Faculty of Pharmacy Cairo University then started her career in the academic field as a teaching assistant up to senior supervisor in pharmaceutical technology department, Faculty of Pharmacy, Misr International University (MIU).

 

After that she moved to the regulatory affairs field where she joined the Registration General Directorate in the Central Administration for Pharmaceutical Affairs (CAPA), Ministry of Health and Population of Egypt. she worked as the Rapporteur of The Technical Committee for Drug Control then she became the Head of Human Pharmaceutical Drug products Registration Directorate before moving to her current position.”

Dr. Aliou Ndiaye

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I hold a Doctorate in Pharmacy from the Faculty of Medicine, Pharmacy, and Dentistry (FMPO) and a Master’s degree in Health Facility and Program Management from the Faculty of Economics and Management Sciences (FASEG).

Additionally, I have received training in the evaluation of drug Marketing Authorization Applications (MAAs) and the digitization of the healthcare system. Throughout my career, I have been involved in the digitization of the healthcare system, particularly in the digitalization of patients’ medical records, care pathways, and healthcare services in Senegal. I have also worked on situational analysis and problem-solving related to the dispensing and misuse of codeine-containing medications.

Currently, I am working at ARP, where I am involved in the implementation of a drug serialization system. I am also engaged in market control and surveillance activities.

 

 

Mr. Samuel Asante-Boateng

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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.

 

Dr. Samia Gamal El Din Seleem

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EDUCATION:

 

–     B.Sc. of Pharmaceutical science – Alexandria University, 1988.

 

  • Business Administration & Marketing Certificate (AUC) 1994

 

  • Health Economics – VSCR (Vienna School for Clinical Research ) 2008

 

  • Total Quality Management for Health care (AUC) Jan-2012

 

 

Joined Egypt Health Authority for 2 years after graduation as registration officer

Worked as regulatory officer for MUP (Egyptian pharmaceutical company –Egypt)

In 1992 Moved to multinational German company (Madaus / Rotta pharm/ Viatris pharma) as medical representative, then different function has been added to her responsibility as planning & production coordinator, Marketing, sales supervisor, till became Deputy General Manager

In 1999 Moved to Eli –Lilly working as Regulatory & Corporate affairs Manager and Quality for Egypt, Sudan & Libya

In 2013 joined the newly established research-based company AbbVie with enthusiasm to patient centric team

 

At the same time I am active with different pharmaceutical associations in Middle East, chairing RWG for pharma in Egypt for 10 years.

Support & coordinate pharmaceutical Industry & health authority to shape the regulatory environment in Egypt. Partnership with Health authority for capability building programs to support patients for better access & affordable medication.

 

Active Member of organizing committee of MERC 2015 & 2017, 2019, 2020 (virtual) and 2023.

 

Dr. Folasade Osho

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Folasade is a Chief Regulatory Officer, at the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria’s Medicine Regulatory Agency.

While Folasade’s primary role in NAFDAC is to implement Quality Management Systems in line with ISO 9001, ISO 17025:2017 and WHO Standards at the National Quality Control Laboratory. She works on the Technical Working Group of the NAFDAC Traceability Office, supporting the execution of the five-year roadmap for implementing pharmaceutical traceability in Nigeria.

Folasade also serves on the NAFDAC-WHO Global Benchmarking Team. This team was constituted in 2018 to drive implementation and institutionalization of WHO Global Benchmarking Requirements in Nigeria’s regulatory System. Folasade coordinates the Laboratory Testing Function on this project. In 2022, the team’s efforts led to Nigeria attaining the WHO GBT Maturity Level (ML) 3 i.e. status of a stable, well-functioning and integrated regulatory system

Folasade trained as a pharmacist, at the University of Lagos, Nigeria. She has a master’s in public health (MPH) from the University of Western Cape South Africa and a Master of Public Policy (MPP) from the University of Oxford, UK.

Dr. Rania Ibrahim Hassan

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She has 19 years’ Experience as Regulator Covering different roles in in various fields as Good Clinical Practice – Good Pharmacovigilance Practice – Regulatory Affairs – Pharmaceutical Production – Quality Assurance – Technical Methodology – GMP Inspection – Health Care Quality , key functions such as Quality Compliance, Documentation, Personnel, Biosafety, Performance Improvement, Validation, and, Strategic Planning, Quality System Management, Management of Quality Function, Project Planning and Initiation, Quality Control Techniques, Production Steps through GMP Trainings and reviewing Manufacturer`s Master files and production summary protocols and working as operation and facility Manager in a Pharmaceutical Company During its renovation phase. And also responsible for assessing and evaluating and monitoring Conduction of different phases of Clinical Trials and also as being QPPV.

 

Furthermore, she has gained significant experience working through EDA task force through the journey of achieving ML 3 in Vaccine scope according to World Health Organization GBT

Dr. Winnie Ng’ang’a

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She has over 10 years of experience in Regulatory Affairs and Government Affairs. She has worked at GSK as the Regulatory Affairs Director for FWCA, OWA and East Africa region. She is well versed with the Africa Regulatory environment and has wide array of achievements in product registrations, divestments, license maintenance, renewals, artwork, labelling, government affairs and strategic planning to support business objectives.

She has a strong skill set in advocacy, legislation, government affairs and is currently the Chairperson of the Kenya Association of Pharmaceutical Industry (KAPI). She has led the industry association in advancing regulations, advocacy, and stakeholder engagements to positively shape the pharmaceutical Industry within East Africa. She is also a council member of Africa Engagement Committee, committee member of the Africa Regulatory Network and Regulatory Science Committee in IFPMA.

Dr. Rehab Mehrez

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Rehab is the Manager of the general Administration of Pharmaceutical References and inserts, Central administration of Pharmaceutical Care, Egyptian Drug Authority

She is a board-certified Pharmacist in pharmacotherapy with a Master’s Degree in the field of clinical biochemistry and oncology

She has completed the clinical research scholarship at Harvard Medical School, postgraduate studies in Policy Development and Advocacy for Global Health at the University of Washington and The advanced leadership skills” training program by the National Training Academy.

Over the span of more than 15 years, Rehab has gained extensive experience in various areas of the life sciences sector, with a focus on Regulatory Affairs, Pharmacovigilance, Patient Safety, Drug/Medicine Information, Medical Affairs, Clinical Pharmacy, and Hospital Accreditation Standards.

In her role as the General Manager of Pharmaceutical References and Leaflets, She and her team lead the Electronic Labelling Project and they feel honored to be pioneers in the Middle East and Africa.

She participated in a number of strategic projects, such as the WHO rational Drug use survey, And also was among many expert Working Committees responsible for achieving the “Egyptian Clinical Pharmacy Standards of Practice”, “Egyptian guidelines of Medication Management standards” and Guidelines for Classification as Nonprescription Medicinal Products (OTC).

 

Dr. Nabiha El Khaldia Boutarene

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Dr. Boutarene El Khaldia Nabiha, Director of Technical Monitoring, Inspection and Vigilance.

Previously head of the technical monitoring unit at the national agency of pharmaceutical products. Head of the Registration Department, then Head of Department at the National Laboratory of pharmaceutical products.