4th Annual Pharmaceutical Regulatory Affairs Summit

15 – 16 May 2024 | Vienna



Summit will host speakers from the world’s leading companies

Frederic Ivanow

Head of Global Regulatory Intelligence & Policy

Martine Zimmermann

SVP, Head of Regulatory & R&D Quality

Joerg Stueben

Head of Regulatory Information Management and Senior Expert

Solange Corriol-Rohou

Senior Director Regulatory Affairs & Policy

Janos Gyimesi Ph.D.

RA/QA//PV Head for MCO EE

Hottest topics that will be discussed this annual

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!

Cover Over 8 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

I really enjoyed the programme and different speakers I had opportunity to hear.

Bayer– Head Regulatory Affairs Radiology Medical Devices EMEA

I really enjoyed learning from highly relevant presentations and lively discussions, and I will be definitely very happy to join the summit next year.

Merck– Associate Director Global Regulatory Affairs, Translational Medicine & Devices

It was a great conference and I was also very impressed with the topics and presentations.

Alexion Pharmaceuticals– Executive Director, International Regulatory Affairs

Informative, has great content, friendly, open. The size of the conference is ideal - wared as a group

Gedeon Richter PLC- Head of Global Regulatory CMC & Operation Department

Few photos from our summits

Event programme

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Inside you will find

  • What keynote speakers will be taking part in the exclusive speaking panel
  • What Case Studies will be discussed by our senior corporate speakers
  • The minute by minute breakdown of the conference