-35+ INDs/CTAs (no clinical holds), multiple indications -20+ marketing applications (no refuse to file or complete response letters), multiple indications -More than 60 “best practices” talks at DIA, RAPS, other associations, and law firms -Active in management of Regulatory Affairs, and Clinical Safety and Pharmacovigilance best practices communities -Located near FDA, attend FDA Advisory Committee […]
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I performed GMP audits for API (ICH Q7 guideline) & Packaging manufacturers in China, India & Malaysia; pre-inspection for pharmaceutical finished products as Thornton & Ross LTD/UK as well. I am Analytical &Technical affairs responsible for the ISO 17025 team and one of the teams responsible for being accredited for ISO 17025 by EGAC & […]
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I have achieved, regarding my portfolios (Pharma/Consumer health/OTC/MD/ Specialities) in the MENA/Levant, during these two years 2019/2020 in a well-known company summarized mainly as: 1. 2019 new applications approvals: 51 SKUs. 2. 2020 new applications submissions: 88 SKUs 3. 2020 new applications approvals/ready for launch: = 50 SKUs. 4. 2020 renewal submissions: 54 products. 5. […]
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Simple, distinctive, and memorable designs representing a variety of products and services.
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Package redesign that included a color-coding system that improved shelf impact and made product selection easier for the consumer.
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Package design and branding update/refresh for Walgreens Theragran-M® multivitamin line.
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Design and branding for a national brand probiotic product with patented GI Guard® technology that protects delicate probiotics from stomach acid. The project included packaging, displays, and national ads to support an $18 million business.
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Package and collateral design for an innovative line of patented medical-grade, silicone-based products for orthodontists and their patients.
READ MOREHighlights of qualifications: Logical data modelling Seasoned architect with strengths in creating integrated designs, across financial, operational and transactional data structures across business domains Data visualization Skillful in creating data visualizations across business hierarchies for executive dashboards and balance scorecards, for drill up / drill down or slicing / dicing Campaign management Proficiency in digital […]
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https://www.phusewiki.org/docs/WorkingGroups/Deliverables/Best%20Practices%20for%20Quality%20Control%20and%20Validation-%20White%20Paper%20.pdf
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Was one of three members of a consulting team designing an national bioequivalence center establishment and operations presenting the project to the MoH in Sudan.
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Delivered dozens of courses to pharma, CROs, IRBs and MENA Regulators. Co-developed LMS and designed dozens of courses on Moodle platform for a CRO. Registered Presenter at CPD (Continuing Professional Development), UK. The most demanding training so far was a 2-week course for a BE CRO on Good Clinical Practice, Good Laboratory Practice, Good Documentation […]
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Implemented latest regulations, guidelines, and guidances, such as the TransCelerate Common Protocol Template, CORE Reference CSR structure, and advanced software for final proofreading, editing, and QC (PerfectIt). Engaged in continuing professional development as a member of DIA and EMWA (the European Medical Writers Association).
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To date, performed 59 audits and quality oversight visits in 7 countries. The most complex audit so far was a BE vendor qualification system audit lasting one week. The auditees included a Clinical Site, a Bioanalytical Laboratory, and a BE CRO, all in different locations; the audit required a process mapping for a BE study […]
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Have been working on projects in MENA since 2003, visited repeatedly most of MENA countries and lived in the region for 7 years. Co-established MENA operations for a global CRO and established the same for a regional CRO. Knowledge of the society, health care systems, regulatory landscape for clinical studies.
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Designed client-specific clinical risk management system, including SOPs and tools (Clinical Risk Management Plan template, Clinical Risk Assessment Protocol, RBM data sheet specification, etc.) and trained personnel in two mid-sized CROs. Co-authored a DIA publication on clinical risk management in Therapeutic Innovation and Regulatory Science (Springer, Jan, 2020).
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