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Wednesday June 18, 2025 8:30am - 9:30am EDT
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-617-L04-P; CME 1.00; RN 1.00

National Regulatory Authorities (NRAs) in the Middle East have been increasingly proactive in aligning their regulatory frameworks with international standards. They are actively participating in global standard-setting platforms such as the International Council for Harmonization (ICH), the International Pharmaceutical Regulators Programme (IPRP), the International Coalition of Medicines Regulatory Authorities (ICMRA), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). In collaboration with the World Health Organization (WHO), these authorities are assessing their regulatory systems through WHO's global benchmarking initiative. This effort aims to achieve higher maturity levels. NRAs have been also committed to global harmonization efforts by obtaining membership in the ICH, as evidenced by countries like Egypt, Saudi Arabia, and Jordan. Notably, the Saudi Food and Drug Authority (SFDA) aspires to become a reference agency in the region, while reaching maturity level four (ML4) for medicines and vaccines regulation.

Learning Objectives

Discuss how evolving the Middle East region has been in the past decade in assessing/benchmarking their systems, attaining higher maturity levels & collaborating across key stakeholders; Identify the support for trainings to enable regulators & stakeholders to serve best patient’s needs; Recognize the key discussions from DIA MENA which took place in November 2024 & DIA Europe (Middle East townhall) in March 2025.

Chair

Amira Deia Younes

Speaker

Panelist
Maria Cristina Mota Pina, MBA

Panelist
Sara Torgal, MPharm

Panelist
Hamada Sherief

Panelist
Donia Albastaki


Speakers
avatar for Donia Albastaki

Donia Albastaki

Acting Director, Pharmaceutical and Herbal Medicine Registration & Control Admin, Ministry of Health, State of Kuwait, Kuwait
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →
HS

Hamada Sherief

Director of the General Administration of Registration of Pharmaceutical, EDA, Egypt
Hamada Sherief is the General Director for Human Pharmaceutical Drugs Registration at the EDA. He’s responsible for authorizing new registrations and re-registrations of human pharmaceutical drugs. His career began as a Quality Control Analyst at NODCAR & research after graduating... Read More →
avatar for Sara Torgal

Sara Torgal

Global Regulatory Policy Lead, DIA, Switzerland
Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA... Read More →
avatar for Amira Younes

Amira Younes

Director, Europe, Middle East & Africa (EMEA) Global Regulatory Policy, MSD, United Arab Emirates
Amira is the Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years of experience in regulatory science and policy. She is recognized as a thought leader in reliance, work sharing, and regional harmonization. Amira has built a strong network... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

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