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
- ISO IDMP
- 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.
