filmeu

Class Regulatory Affairs I

  • Presentation

    Presentation

    The Regulatory Affairs curricular unit allows to acquire skills and knowledge, in the most important areas of regulation of health products (including medical devices, cosmetics and body care) and food supplements.

  • Code

    Code

    ULHT2629-17176
  • Syllabus

    Syllabus

    Unit 1. Regulation of health products

    Device Regulation Doctors and Cosmetics
    General concepts of regulation of health products and Medical devices:
    - Border Demarcation and classification of medical devices
    - Conformity assessment
    - Registration of medical devices

    Cosmetic products:
    - Manufacture and import
    - Safety Assessment

    Cosmetic market control
    Pharmacovigilance and Surveillance Medical Devices
    National and European system Pharmacovigilance
    Risk management and mitigation measures
    additional monitoring

    Unit 2. Regulation of food supplements
    - General concepts of regulation of dietary supplements
    - European System of Regulation and Competent Authorities
    - Products-border Supplements and Medications
    - Border Demarcation with medicinal products

    • the multivitamins, vitamins and minerals
    • the "diet products" and "Naturopathy"
    • The sweeteners and fat substitutes
    • the Food Innovations and functional foods



  • Objectives

    Objectives

    The aim of the course is to provide advanced training and the acquisition of skills and knowledge in a systematic way, in the most important areas of regulation of health products (including medical devices, cosmetics and body care) and food supplements.
    Skills developed during the classes:
    - Search and retrieve regulatory information about health products and food supplements
    - Knowledge and aplication the concepts related to regulation of health products and food supplements
    - Strengthening the knowledge that allow the performance of professional duties in this area or to improve their professional performance if already working in the area in question.

    The Course consists of two training units (Regulation on health products and regulations applied to food supplements).

  • Teaching methodologies and assessment

    Teaching methodologies and assessment

    Innovative methodologies to support the teaching-learning process used:
    
    1. Tutoring of professionals from Competent Authorities with "hands-on" Sessions of real Cases (notification of a Supplementos Alimenatr on the DGAV page, issuance of Scientific Opinion to ASAE, etc.) for internalization of real professional skills in a real context.
    
    2. Design of a "Product" with all justifications of Quality, Safety and Effectiveness compliance regardless of regulatory degrees of freedom - perception of what professional responsibility is.
  • References

    References

    • União Europeia Com EU - Regulamento (UE) nº 432/2012 . [ 16 de maio de 2012, que estabelece uma lista de alegações de saúde permitidas relativas a alimentos que não referem a redução de um risco de doença ou o desenvolvimento e a saúde das crianças. JO, L 136:1-40
    • Comissão Europeia , Parlamento EU, Regulamento (CE) nº 1924/2006. 20 de dezembro de 2006, relativo às alegações nutricionais e de saúde sobre os alimentos.JO,L404:9-25

     

SINGLE REGISTRATION
Cookie Policy
This site uses cookies to offer you a better browsing experience.
Accept
Lisboa 2020 Portugal 2020 Small Logo EU small Logo PRR republica 150x50 Logo UE Financed Provedor do Estudante Livro de reclamaões Elogios