Mohammed Hakami Email & Phone Number

Riyadh, Saudi Arabia

Saudi Arabia

Al-Riyadh Governorate, Saudi Arabia

• Reviewing and evaluating pre-registered files, which covers many qualityaspects of pharmaceutical products (Phase II projects).• Verifying assessment decisions on drug substances conducted by subordinatepharmaceutical assessors, ensuring national standards are maintained andassessment needs of candidates are being met.• Identifying and addressing the learning and development needs of Assessors.(Training new employees).• Liaising with the other departments to ensure progress and conclusion of theapplication within the agreed-upon time frame.

Al-Riyadh Governorate, Saudi Arabia

• Drug registration files validation (phase I and Phase II Project).• Evaluation of quality parts of medicinal products’ applications ensuring theymeet both national and international standards. This covers the quality of rawmaterials, finished products, and analytical procedures with their validations.• Reviewing and evaluating registration applications of pharmaceutical productsapplied to GCC. Evaluation of renewal dossiers of pharmaceutical products.• Reception of les from GCC central committee for drug registration.• GCC files validation (for drug registration, variations, and renewals).• Submission to evaluating departments and following up.• Strong understanding of SFDA guidelines and current thinking of theorganization in addition to other guidelines of international authoritiessuch as FDA, EMA, Health Canada, ICH, and WHO.• Quality audits (GMP inspection) conducted by SFDA on pharmaceutical plants.• Participating and training in other International authorities: EDQM, EuropeanPharmacopoeia, HALMED (Agency for Medicinal Products and Medical Devicesof Croatia), Malta Medicines Authority.

Al-Riyadh Governorate, Saudi Arabia

• Reception, validation of variations requests.• Submission of variations to evaluating departments and following up.• Reviewing and evaluating post-approval variations’ les which cover manyquality aspects of pharmaceutical products• Writing responses and nal approval letters for variations topharmaceutical companies.

Al-Riyadh Governorate, Saudi Arabia

• Assuring certication payments were received by SFDA.• Assuring all registration/renewal requirements are fullled.• Reviewing the product registration information.• Updating products information on SFDA systems, including SDR.Website (registration, renewal, and variationsubmissions), SFDA website, registration system.• Issuing registration and renewal certicate.• Responding to company inquiries (either letters, phones or emails).

I worked as pharmacist in different pharmacies "out-patient, in-patient and IV-room". For three months then I was assigned at the in-patient pharmacy for another four months.