Yousef Alharbi

Background

About Yousef Alharbi

Strong academic background in pharmaceutical science and medical device combined with over 15 years work experience in regulation.• A very wide experience at- Registration documents and requirements as per the CTD format and eCTD format for different classes of products including food, medicine and medical devices- Seating and updating regulatory guidelines and guidance for industry- Classifying the therapeutic goods which require or not require premarket approval- inspecting ( auditting) the Pharmaceutical manufacturing companies to assure compliance with GMP guideline- Professional analysis for the advocacy and position letters from various industry and trade associations- Representing formal meeting with SFDA relevant stakeholders- Serving as SFDA formal representative at various levels of stakeholders including public media, professional associations, industry associations- Effective contribution in meetings, conferences and relevant SFDA meetings both at local and international level- Supporting various regulatory authorities across the middle east (ME) with regulatory and policy developments- Excellent world communication across 34-member states Regional/Sub-regional bodies though the Mednet platform provided by WHO- Identify the risks and mitigate /manage them in the most effective ways possible.Past membership • International regulatory cooperation for Herbal Medicines, WHO.• Herbal and health product registration committee, Saudi FDA.• Classification committee, Saudi FDA.• An import permit of narcotics, ministry of interior.• Blood products committee, Saudi FDA.• Food with medical claims committee, Saudi FDA.• Complementary and alternative medicine, Saudi Health Council.