Medicines for Europe - 18th Regulatory and Scientific Affairs Conference

31 January 2019


  • Tackling the effects of the globalisation of pharmaceutical operations – challenges, opportunities and priorities
  • Countdown to Brexit – the latest update on the withdrawal agreement and regulatory consequences
  • Implementation of the Medical Device Regulation – how is it going to affect combination products?
  • Recent developments in the EU telematics environment and the way forward in 2019
  • Global development for generics/ complex generics – can a dream come true?
  • Evolution of the Environmental Risk Assessment for Medicines – what should the regulatory experts know about future changes?
  • Electronic product information – what is the best model and standard for the future?
  • API Supply chain – the interplay between GMP and regulatory obligations – how to find the right balance between compliance, transparency and operability?

SPECIAL SESSION: Put questions to the Regulators. An opportunity to address questions to the European Regulators


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The Tower Hotel
St Katharine's
London E1W 1LD, UK