Amr Adel

Experience

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  PHARAONIA Pharmaceuticals

  Feb 2017 - Dec 2017

  Pharmaceutical inspection Specialist

  -Searching for innovator product of newly required generic product, to acquire complete scientific feedback concerning the product active raw materials, their strengths, delivered dosage form and the product potency.-Complete all inquiries requests and applications originating from government agencies for registration & re-registration of different pharmaceutical products.-Co-work with R&D department, which supply the registration with steady stream of data and technical details required for registration files.-Filling all data for the company and government agencies according to specific requirements of each file: Technical file, NODCAR file, Stability Study file, In vitro Comparative Dissolution Show less

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  Ultimate Pharma

  Dec 2017 - Jul 2022

  Regulatory Affairs Specialist

  Regulatory Affairs Specialist :• Handling all regulatory issues with the concerned local authority • Preparation and timely submission of registration requested documents for Human drug products and medical devices according to ministerial decrees (applying for new registration- creation naming lists- layout - pricing files -Hard file submissions –stability studies & in vitro dissolution studies submission – Bioequivalence studies submission) and follow up till receiving final registration certificate in accordance with production, Marketing and sales needs.• NODCAR responsibilities: Preparation NODCAR registration files and fulfill all requirements, follow up analysis process and Securing the routinely release of already registered and marketed products duo to variation required. Put and secure the launch dates of the products.• Maintenance of the already existing marketed products and preparing and submission of variation files and follow up till final approval.• Follow up Re-Registration files.• Pharmacology and artwork related activities (Inserts creation and translation, Handling Safety labeling updates• Preparing and submission of Promotional material files.• Handling Inspection related complains.• Communicating globally to fulfill all required needed by MOH.• Importation of raw material related activities, Creation import permission files and annual import plan and consequently releases. • Communicating with others companies in case of Toll-In and Toll-Out• Cooperating with business development in selecting new generic products and discovering new opportunities and box availabilities.• To anticipate and resolve complex regulatory issues independently and via influencing the authorities using strong access and good relations to shape the environment. Show less

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  RA Community

  Dec 2021 - now

  Professional Regulatory Affairs Trainer & RA Community Founder

  RA Community FounderLink:https://t.me/+cki1vB1S_HtlNjM8- Making a Free Online Sessions About Regulatory Affairs Field, For Helping My Colleges Whoes want Joining Regulatory Affairs Feild Sharing With Them My Passion, Knowlege, Experience - Organizing a Payied Proffisional Regulaory Affairs Course

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  Grifols

  Jul 2022 - now

  Regulatory Affairs and Quality Compliance

  •Prepare All The Documentation Related To Technical Information Referred To BloodEstablishments (Plasma Centers, Plasma Logistic Centers (PLC), And Plasma TestingLaboratory).•Prepare Site Master File Of All Blood Establishments.•Submission Of All Documentation Related To The Application Of Blood EstablishmentsInvolved Along the Plasma Supply Chain, To Health Authorities.•Coordinate Through The Different Areas Involved The Responses To Provide To HealthAuthorities And Government Authorities When It's Required.•Compile All The Information Related To The Different Processes Referred To Key ProcessIndicators Established.•Prepare And Provide Support To The Quality Committee.•To Assist On Preparing Quality Review Report For Further Evaluation By senior management•Preparation And Timely Submission of Registration Requested Documents for BiologicalProducts According to Ministerial Decrees (Applying for New Registration- CreationNaming Lists- Layout - Pricing Files -Hard File Submissions – & Stability Studies ) And Follow Up till receiving Final Registration Certificate in Accordance with Production, Marketing, and sales Needs.•NODCAR Responsibilities: Preparation of NODCAR Registration Files and Fulfill All Requirements, Follow Up Analysis Process, and Securing the Routinely Release of AlreadyRegistered and Marketed Products Duo to Variation Required. Put And Secure the launch Dates of The Products.•Maintenance Of the Already Existing Marketed Products and Preparing and Submission of Variation Files and Follow Up till Final Approval.-Follow Up Re-Registration Files.•Pharmacology And Artwork Related Activities (Inserts Creation and Translation, Handling Safety Labeling Updates•Handling Inspection Related Complains.•Communicating Globally to Fulfill All Required Needed By EDA.•Importation Of Raw Material Related Activities, Creation of Imports Permission Files and Annual Import Plan and Consequently Releases. Show less