IDMP implementation in Europe could contribute to alleviate the drug shortage problems in the region if implemented swiftly and with the right process.

Speaker:

Rodrigo Palacios
Regulatory Technology Policy Lead
Roche

While Regulatory continues to expand on RIM solutions, how are we developing these systems to better support the next wave of innovation? The future is in cross-functional integration, connecting Regulatory to other organizations where natural synergies exist. RIM systems must be designed to share common data and processes with areas such as Quality and Pharmacovigilance in order to work more efficiently and accurately.

This presentation will explore:

• Current and next gen regulatory technologies
• Identifying gaps and barriers to integration
• Automation and AI, where do we draw the line and remain compliant?
• How next gen will facilitate integration with Safety, Quality, and more
• The need for process reformation to support the future of regulations

Speaker:

Michelle Gyzen,
Senior Director
Integrated Global Compliance, IQVIA

Throughout the different verticals within life sciences, the uptake of AI software solutions has been growing at different rates. Regulatory Affairs and their solution providers have been conservative in their update of AI. However, the drive to embrace AI solutions within regulatory affairs is increasing due to multiple current and future challenges, e.g. due to the ever-increasing focus on standardisation by the regulators, a solution to aid stringent data management is essential.
In this session, we will explore:

• What are some known barriers to implementing AI?
• Why AI is one answer to addressing regulatory challenges?
• What elements of AI are driving value for RIMS (e.g. Machine Learning, Natural Language Processing, Robotic Process Automation)
• How RIMS are utilizing AI to ease and accelerate regulatory processes today and, in the future.

Speaker:

Christina Johnston
Associate Director, Regulatory
ArisGlobal

TBD.

Speakers:

Vada A. Perkins
Executive Director, Regulatory Policy & Intelligence Head
Regulatory Intelligence, Bayer

Remco Munnik
Associate Director
Iperion