17th Regulatory and Scientific Affairs Conference

• Availability of medicines – How to prevent and better mitigate shortages
• Regulatory consequences of Brexit
• Simplifying variations – update on regulatory optimisation
• Implementation phase of the EU/USA Mutual Recognition Agreement (MRA) – How to maximize the benefits
• New ICH quality guidelines under development: Q11 and Q12 – what is new and what impact can be expected?
• Falsified Medicines – what should the regulatory experts know about practical implementation?
• How can patients be provided with up to date and relevant information on their medicines?
• Regulatory challenges for repurposing established medicines
• From junior to senior regulatory affairs – How to shape the best regulatory team

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