4th Annual Pharmaceutical Regulatory Affairs Summit

Our world is in a constant state of evolution, with advanced technologies and digitalisation reshaping the landscape. Implementing AI and Cloud technology raises important questions about how they will impact the regulation of pharmaceutical products. Are pharmaceutical companies prepared for this new era?

The 4th Annual Pharmaceutical Regulatory Affairs Summit has been meticulously crafted to comprehensively address the pressing issues in Regulatory Affairs, including the transformative impact of digitalisation and AI. In addition, our event will spotlight the following hot themes: patient-centeredness, fostering innovation, and navigating the 'adjustments to EU Pharmaceutical Strategy' and many others. 

Take the opportunity to network with senior-level decision-makers, share your ideas, gain crucial insights, and get inspired by the future of pharmaceutical regulation. Join us to learn, implement, and benefit from the remarkable developments in this dynamic industry!

Join us and register today

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Key speakers

Helena Corte-Real Correia

Helena Corte-Real Correia

VP Regulatory Portfolio Data and Content Lead
Anna Litsiou

Anna Litsiou

Regulatory Policy and Intelligence Director — International Region & China
Tim Powell

Tim Powell

Director, Regulatory Submission Sciences
Martine Zimmermann

Martine Zimmermann

SVP, Head of Regulatory & R&D Quality
Anne Marie Jonker-Huisman

Anne Marie Jonker-Huisman

VP Regulatory Affairs, Established Markets and Global Regulatory Operations

Key topics

  • Digitalisation in Regulatory Submissions: The latest trends in electronic submissions (eSubmissions) and the shift towards paperless regulatory processes
  • Data integrity and security: Challenges in ensuring data integrity and security in the digital regulatory environment and the way to solve it
  • How are regulatory affairs shaping the development of cutting-edge pharma innovation?
  • Exploring AI’s Impact on Drug Regulation and Approval
  • Examining successful case studies of data-driven regulatory decision-making: How have data analytics and real-world evidence contributed to more informed and efficient regulatory processes?
  • Regulatory framework for emerging technologies: Developing a robust regulatory framework that accommodates emerging technologies, such as AI, digital health, and advanced manufacturing
  • Driving Progress in Pharmaceutical Regulatory Affairs with the EU Pharmaceutical Strategy
  • Updates on regional regulatory policies and their implications for market access and patient care

Who Should Attend

Members of board, C-level, Senior/Global Vice Presidents, Directors, Heads of departments from pharmaceutical industry involved in:

  • Regulatory Affairs
  • Regulatory Intelligence
  • Regulatory Policy
  • Regulatory Compliance
  • Regulatory Operations
  • Regulatory Project Management
  • Regulatory Information Management
  • Regulatory Devices
  • Regulatory Strategy
  • Regulatory Submission
  • Regulatory Sciences
  • Regulatory Documentation
  • Regulatory Labelling
  • Regulatory Development
  • Data Collection
  • Data Management
  • Lifecycle Management
  • Regulatory Writing
  • Scientific Affairs