Nawar Hamza

Responsible for all the RA activities within Qualiphar NV. Leading a team of 7 RA Officers as direct reports. Activities: includes but not limited to: Ensuring effective planning, proper coordination and oversight of activities in line with the overall project plan and RA milestones. Providing robust regulatory advice and plans to ensure understanding and alignment of company objectives with applicable regulations and/or regulatory advice received from the agencies. In consultation with the other department managers/directors, arrive at well founded decisions on operational matters. Obtaining and keeping up-to date registrations and notifications. People management and ensuring the necessary knowledge, skills, attitudes required to realize the proposed strategy within the RA department. Qualiphar portfolio: consists of different pharmaceutical/health products: Medicines (e.g. Medica, Toularynx), Medical devices (Physiologica, Shampoux), Food Supplements (e.g. Biocure Megatone, Biocure Resist) Biocides (Mouskito Tropical, Mouskito Anti-tick) & Cosmetics (e.g. Lamiderm).

RA Consultancy provides services for the pharmaceutical companies within Regulatory Affairs, Quality Assurance and Pharmacovigilance for Benelux and EU region. Can act as Local RA Responsible Can act as RIP (Responsible Pharmacist for Information & Publicity) Can act as RP GDP (Responsible Person for Distribution of Medicines) Can act as LP PV (Local Person for Pharmacovigilance)

Responsible for all the RA activities within EG (company of STADA group). Leading a team of 4 RA Officers (pharmacists) as direct reports. Activities: includes but not limited to: Coordination and participation in the activities of the Pharmaceutical Affairs (PA) department; compile, analyze and submit new registration dossiers; following up registration procedures and maintaining existing registrations; provide assistance to internal (e.g. sales and marketing department) and external (e.g. health professionals, customers) stakeholders; following up on evolutions within Regulatory Affairs to obtain registrations of new medicines (including notification of food supplements and medical devices) and to maintain existing registrations so that these products can be brought to the market as quickly as possible and a good sale can be realized. Acting as main contact

to the Regulatory Agencies (e.g. FAMHP, Luxembourg Ministry of Health). Guidance and training of the Regulatory Affairs employees in the various tasks and projects. Participation to the Quality Management Meeting. Develop RA/PV/QA strategies within PA department. EG portfolio: Generic medicines (Rx & OTC) like Propranolol EG, Ibuprofen EG, Paracetamol EG, etc. Food supplements like Protectis, Curcufen, Hirudoid, Fultium, etc. Medical devices like Silikom, Viruprotect and Glandosane.