Medicines for Europe - 18th Regulatory and Scientific Affairs Conference

• 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