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23-25 October 2018
Hotel Palace Berlin,

Achieve EU harmonisation and track critical regulatory changes through authority access and industry expertise

Thank you for attending the 2017 event - check back soon for more details about 2018!

new Strategies to navigate the changing EU regulatory landscape

Direct feedback from Regulatory Agencies
  • Insight from EMA, EU Commission, DG SANTE, MHRA and the Danish Medicines Agency
  • Latest initiatives to improve and streamline harmonisation processes
  • PRAC share updates on new signal assessments and pharmacovigilance 
  • Preparing for changes to eSubmissions: implications and timelines
  • Orphan legislation: supporting the development of medicines for special populations
Key Regulatory Updates
  • Learn from innovative and generic companies including: Roche, AstraZenca, Pfizer, GlaxoSmithKline, Sanofi and Teva
  • Clinical Trials Regulation 536/2014: best practice for timely implementation
  • Falsified Medicines Directive: impact on serialisaton and coding requirements
  • Improve consistency and readability in pharmaceutical labelling
  • Market Authorisation in various jurisdictions: improve dossier alignment 
Co-located with EU Pharmaceutical Law Forum
  • In-house counsel and private practice explain the legal side of regulatory affairs
  • Feedback from the EMA framing emerging technologies: nanomedicines
  • Analysis of regulatory data protection and market protection
  • Understand the increasing requirements for market access and managed entry agreements
  • Examining advertising on mobile apps: what are the legal challenges?


Bringing together regulatory professionals from all functions

For the first time ever, our regulatory affairs conference brings together pharmaceutical regulatory professionals from each function, with discussions on the hottest topics that are affecting the industry.

Meet with the pharmaceutical regulatory affairs community for improved knowledge, networking and experience the exchange of knowledge and best practices

Maximise time efficiency onsite with the new networking app
  • Set up one-to-one meetings
  • Browse the delegate list
  • Access speaker presentations
  • View the latest agenda
  • Vote on industry hot-topics
The Venue

Hotel Palace Berlin, Budapester Str. 45, 10787 Berlin, Germany

More information on the reduced rate accommodation to be announced shortly. 

2017 Sponsors

In Partnership with

2017 Media Partners