• LinkedIn
SFL Regulatory Affairs & Scientific Communication Ltd.
  • About SFL
    • Why SFL
    • Team
    • Associations
    • History
    • Awards
    • Ethics
  • Services
    • Regulatory Affairs
    • Quality Assurance & GxP Compliance
    • Medical Affairs & Communication
    • Market Access & Reimbursement
    • Public Affairs & Regulatory Intelligence
    • Medical Devices, Combination Products and IVDs
    • Pharmacovigilance & Clinical Safety
    • Supply Chains of Medicines and Devices
    • Legal & Healthcare Compliance
    • Swiss Support
    • UK Support
    • Clinical Trials support
  • Clients
    • Testimonials
    • Cases
  • Trainings
    • Customized training
    • Webinars
  • News
    • News
    • Newsletter
  • Careers
  • Contact
  • Search
  • Menu Menu

Per Helboe

Professor Per Helboe is an expert in regulatory affairs and provides strategic advice to clients on quality and regulatory-related product matters. He is a Professor in Regulatory Affairs at the University of Copenhagen, Faculty of Health and Medical Sciences and was Senior Director and Head of the Licensing Division of the Danish Medicines Agency from 2001 until his retirement in 2011.

Professor Helboe was instrumental in formalizing cooperation between the Danish Medicines Agency and China’s State Food and Drug Administration (SFDA), with Denmark being one of the first EU countries to enter into this type of agreement with China. He was also active in the ICH harmonization process, serving as an EU representative on quality issues, and acted as the EU ICH Coordinator for Quality between 1995 and 2001.

Professor Helboe was actively involved in setting the EU standards on requirements for the quality part of marketing authorization dossiers. From its founding until 2001, he was a member of the CHMP Quality Working Party and chaired the group for two years. He has also been involved in several working groups on issues relating to the digitalization of licensing procedures in the EU.

Per Helboe

Per Helboe

SFL Regulatory Affairs & Scientific Communication Ltd.

Switzerland – Main Office

SFL Regulatory Affairs & Scientific Communication GmbH
Aeschenvorstadt 52 | CH-4051 Basel
Email: office@sfl-services.com
Phone: +41 61 361 9443

© Copyright 2023 - SFL Regulatory Affairs & Scientific Communication GmbH | Terms and Conditions | Privacy Statement | Cookies Policy
Scroll to top