Dublin, the venue
It was our pleasure to host the EuDRAcon conference for 2017 in Ireland on 1st and 2nd of June. We welcomed representatives from 21 Member States, including our new member from Cyprus, Nicolas Constantinou from Niconex Medical. EuDRAcon currently has participating members in 25 of the current 31 EEA member states, plus Switzerland, providing unrivalled EU/EEA coverage and support.
We were also grateful to Kevin Horan, Director of ICT and Business Services, HPRA who participated and provided us with valued insights into the future of ICT in the EU.
What was discussed
The discussions included
- 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
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