Ahmed Aly

Medicine unit registration supervisor & - Rapporteur of Permanent Registration Committee of Pharmaceutical Companies & ProductsFull Time

• Job Details:- Rapporteur of Permanent Registration Committee of Pharmaceutical Companies & Products with all related tasks of preparing meeting agenda, presenting and discussing different topics and issues to the committee members, liaising with different stakeholders and issuing approval and rejection letters. - Double-checking the assessment reports for new pharmaceutical products and companies before presenting to the committee - Preparing the recall, safety and quality concerns circulars for the affected pharmaceutical products. - Reviewing and assessing the CTD & eCTD files for new pharmaceutical products submitted for registration (around 160 files) - Reviewing and assessing the CTD, NeeS files submitted for registration centrally in GCC countries - Assessment of minor changes including changes in safety, clinical, quality, shelf life, stability & all manufacturing processes (around 600 files) - Rapporteur of Permanent Registration Committee of Pharmaceutical Companies & Products with all related tasks of preparing meeting agenda, presenting and discussing different topics and issues to the committee members, liaising with different stakeholders and issuing approval and rejection letters. - Liaising where needed with different sections to ensure the quality and compliance of different products intended to be placed in the market - Acting as a front disc pharmacist taking responsibility of receiving the new registration files - Actively participated in the updating of the minor change and renewal guidelines of pharmaceutical products(2017) - Actively participated in the registered pharmaceutical products database update project 2013 - Actively participated in pricing registered pharmaceutical products project with the main objective of unifying the prices of all pharmaceutical products across GCC region (2014 – 2018)

Senior Regulatory Affairs Specialist – Assessor of clinical pharmacology committeeFull Time

• Job Details:- Reviewing memos received from The Egyptian Pharmacovigilance Center (EPVC) concerning reported adverse drug events, precautionary measures or contra-indications for any health product, and taking the necessary actions in relation to updating products information and package leaflets - Reviewing and approval of package leaflets for all pharmaceutical products in accordance with the most updated information published by international health authorities (FDA, EMEA, AFSSAPS, TGA, …), and ensuring the addition of any safety recommendations circulated from CAPA technical, specialized and pharmacology committees as well as EPVC safety concerns - Evaluation of any claimed therapeutic indications for any pharmaceutical product by conducting comprehensive systematic search for clinical databases as well as clinical guidelines and reports published by international health organizations

Community PharmacistFull Time

• Job Details:- Undertake all actions related to ensuring the compliance of the pharmacy with the establishment and health authorities’ requirements - Dispensing medicines and provide the required knowledge related to the medicine use and their precautions - Connecting with the wholesalers and stores to ensure adequate supply of all products and prevent any shortage