Niconex Medical participated in the EuDRAcon conference for 2017 of the pan-European network of Drug Regulatory Affairs consultancy companies, hosted by Ivowen Limited in Ireland. We had the opportunity to share many discussions including:

  • an overview of local requirements specific to Cyprus (MAAs, PV, fees, pricing and reimbursement),
  • a summary of a recently successful Article 29 referral to the CHMP
  • Electronic submission roadmap
  • Substance, Product, Organisation, Referential (SPOR)
  • Regulatory Optimisation Group of HMA – background and work plan
  • BREXIT – what it means to us

The conference for 2017 was additionally marked with an honour and a privilege for Niconex Medical to become a EuDRAcon member as the representative company from Cyprus.  Our sincere appreciation towards all partner companies.