Anna Naef

a.naefnoSpam@axxos.noSpamch

    • MSc Human Movement Sciences and Sport, Major in Biomechanics, ETH Zürich
    • Teaching diploma in Sport, ETH Zürich
    • Swiss Olympic Sports Coach with Federal PET Diploma
    • Trainings in Regulatory Affairs, Pharmacovigilance, Project Management

    Head of Clinical Evaluation
    Senior Consultant at Axxos GmbH since 2016 

      Experience

      • Clinical Evaluation Reports according to MEDDEV 2.7.1 / Revision 4 
      • 5 years pharmaceutical industry
      • Medical Affairs: Promotional compliance, medical product support
      • Regulatory Affairs: Registration in Switzerland, Life Cycle Management
      • Pharmacovigilance/Materiovigilance
      • Over the counter medicinal products
      • Laws and standards relevant for the medical device industry
      • Lecturer at SAQ Qualicon for clinical evaluation (www.saq-qualicon.ch)

      Projects

      • Clinical Evaluation according to MEDDEV 2.7.1 / Revision 4 among others for orthopaedic implants including spinal cages and anchor systems, CMF implants, navigation systems, disinfecting solutions, ophthalmologic instruments, breastmilk pumps
      • Successful preparation of processes and documentation for internal pharmacovigilance audit
      • Medical and juridical evaluation of several marketing and sales projects
      • Inhouse training for clinical evaluation reports
      • Process owner of the Axxos update service for laws and standards

      Skills

      • Materiovigilance / Pharmacovigilance
      • Promotional compliance of medical devices and medicinal products in Switzerland
      • Over-the-counter medicinal products
      • Development and implementation of Standard Operating Procedures (SOP) in a highly regulated environment
      • Systematic scientific literature search and evaluation

      My personal scrabble