BOOK BY 9 MAY SAVE £1100:
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21-23 October 2025
Hotel Palace BerlinBerlin, DE21-23 October 2025
Hotel Palace Berlin,
Berlin, DE
Hotel Palace Berlin,
Berlin, DE
Tackle Regulatory Changes with Confidence: Unlock Your Next-Level Playbook to IDMP, RIM & Global eSubmissions
The premier conference to reunite with regulatory authorities and industry leaders and discuss the latest guidance, tools, and strategies in pharmaceutical legislation, regulatory information management and eSubmissions
Empowering Pharma Professionals to Modernise Regulatory Operations: Expert Submissions, Data Integrity & Digital Transformation
Building on the valuable insights from our dynamic community, we’re set to deliver another game-changing event. Whether you’re returning or joining us for the first time, get ready for an enhanced agenda filled with innovative topics to elevate your regulatory processes. Don’t just hear about it — get a sneak peek into what awaits at GPRAS 2025!
Regulatory Information Management and Digital Transformation
- Dive deep into cutting-edge strategies for implementing and supercharging Regulatory Information Management systems
- Embark on an exhilarating journey through the digital transformation of regulatory processes
- Unlock the potential of artificial intelligence and cloud technologies in revolutionizing regulatory affairs
IDMP (Identification of Medicinal Products) Implementation
- Gain insider insights into the current status of IDMP implementation from European regulators' perspectives
- Unravel complex industry hurdles and discover innovative approaches in IDMP adoption
- Explore groundbreaking applications of IDMP data across diverse regulatory initiatives
EU Pharmaceutical Package and Legislative Updates
- Unpack the key components of the new EU Pharmaceutical Package with expert precision
- Navigate the intricate updates to the EU Variations Framework with confidence
- Strategise and streamline the implementation process of the Health Technology Assessment Regulation
The Future of eCTD and Beyond
- Conduct a comprehensive analysis of eCTD implementation worldwide, highlighting regional nuances
- Engage in forward-thinking discussions on the evolution of eCTD standards, with a focus on version 4.0
- Dissect real-world case studies of triumphant eCTD submissions, extracting valuable lessons
AI and Technology in Regulatory Affairs
- Uncover game-changing AI applications in medical and technical writing
- Delve into cutting-edge AI techniques for streamlining IDMP data extraction and validation
- Evaluate state-of-the-art AI tools designed to transform and expedite regulatory submissions
Data Management and Standardization
- Sharpen your ability to distinguish between master data management and regulatory information management
- Explore the intricate world of global identifiers and substance management standardisation processes
- Develop strategies to enhance data ownership, quality, and exchange practices in regulatory processes
The All-Star Speakers Leading the Charge Global Pharmaceutical Regulatory Affairs Summit 2025
Connect and Network with Key Decision-Makers at Global Pharmaceutical Regulatory Affairs Summit
Whether you’re looking to generate quality leads, showcase thought leaders or reinforce your brand, collaborate with us to identify custom sponsorship opportunities to help you reach your business objectives
Contact Lisa Marzoli to learn more about sponsorship opportunities: LisaM@informaconnectls.com