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Houssein IBRAHIM HOUMED

Regulatory Affairs

Regulatory affairs
Medical Devices
Safety Drug
Quality Assurance
Clinical Trials
Houssein IBRAHIM HOUMED
Professional Status
Employed
Available
About Me
Msc Medicine, Msc Business Law, Msc Philosophy

I offer you my expertise in the field of Regulatory Affairs Pharmaceuticals or medical devices. Immediate availability.
Resume created on DoYouBuzz
  • International English Language Testing System (IELTS)
  • -Implementation ISO 15189 of the Quality Manual of the P4ML Laboratory
    -Good knowledge EU 2017/745 and Regulation EU 2017/746
    -Good Knowledge of ISO 15189 v2007, v2012, v2014
    -Good knowledge of ISO 17025 v2005 and cor 2006/- Knowledge of ISO 9001
    -Good Knowledge of ISO 13485: 2016 Quality management for medical devices
    -Good Knowledge of ISO 14971/ ISO 11607
    -Respect of the recommendations of the Royal College of Pathologists of Ireland (RCPAth) for pathology laboratories
    -translation in French of the booklet "The value of non-invasive prenatal testing (NIPT)" of the brochure "the reassurance of knowing" + Eolas Plus Prenatal Test
  • 1 / Ensure the administrative management of projects
    2 / Ensuring the update of the administrative platform of managed projects
    3 / Ensure the management of the files of classification of the studies,
    4 / Ensure the follow-up of the service providers for the printing, translation and supply of specific equipment activities
    5/Realize, at the request of the promoter, help tools for the centers Therapeutic areas: Oncology, organ transplantation and self-modulation,Heavy heumatology, Interventional Cardiology, Degenerative Neurology, endocrinology, IDS )
  • Regulatory Affairs (September 2016 to March 2017)
    1. Watch out for future regulatory trends ahead of public communication
    2. Provides within the LFB all the positions on the regulatory impact that can be have the pharmaceutical regulatory news on its activities,
    3. informs internally and mobilizes trades skills on regulatory texts pharmaceutical
      products under design, consultation or revision,
    4. Promote these positions with health regulatory agencies during meetings
    5. Update the Regulatory Competitive Intelligence Database (AMM, PIP, SDG)
      .
      Safety Drug (March 2017 to September 2017)
      -Management Procedures: ICSR spontaneous and solicited/
      -Management of the SDEA file -Safety Data Exchange Agreement (writing
      management of an SDEA, update of the templates compliance with local regulations)
  • Companies of business lawyers from major French and English firms, who advise
    (companies and managers) on a daily basis in the definition of strategies and decision
    making throughout the life of business.
  • -Provide theoretical or practical instruction to students.
    -Pursue and publish basic and applied research.
    -Provide work methods to students and coach them
    -Assist and advise students in their work.
    -Participate in the development of research programs

Master’s Degree Courses Health Law -

University of Rennes 1

September 2015 to June 2016
UE1 - Health Law
UE2 - Social protection law
UE3 - International and European protection of fundamental rights/
UE4 - Public budgets and accounting
Citizenship of the European Union
UE5 - Hospital Law

Master's Degree Pharmaceutical Sciences Drug- Regulatory Affairs

Faculty of Pharmacy -University of Strasbourg

September 2016 to September 2017
  • MAA files: technical and regulatory aspects
  • Registration of medicines derived from biotechnology processes
  • European institutions and registration procedures
    health products
  • Registration of medicines in Africa / Asia / United States / Japan
  • Pharmacovigilance and materovigilance
  • Pharmaco-economics
  • Regulatory aspects of clinical trials
  • Factory tour
  • Communication and development of behavioral technicals

Master’s Degree Private Law-Business Law

University of Rennes 1

October 2014 to January 2016
Semester 1
UE1 - Tax law of the company
UE2 - Competition Law
UE3 - Methods of the legal exercises
UE4 - Upgrading in business law

Semester 2
UE5 - Company law in difficulty
UE6 - Corporate Tax Law
UE7 - Civil law for business
UE8 - Orientation subjects for the Master 2

Master’s Degree Philosophy

University Paris-IV-Sorbonne

September 2009 to June 2010
  • MA files and variations
  • Medical Devices: MDD 93/42/CE and MDR 2017/745 and 2017/746, ISO 13485 and ISO 17025
  • Strong communication and organizational skills
  • Autonomous and quick learner
  • Flexible and open-minded