Navigating Reg Ops Evolution - Regulations, AI & Automation

Navigating Reg Ops Evolution - Regulations, AI & Automation
This session focuses on how the Regulatory Operations (RegOps) function is evolving driven by several technology and regulation factors.

A webinar organised by the TOPRA Regulatory Operations SPIN





Date: Wednesday 15 January 2025
Time: 14:00 - 15:00 GMT / 15:00 - 16:00 CET
Duration: 1 hour

Suitable for TOPRA Members & TOPRA Special Interest Groups (SPIN) interested in:

  • Regulatory
  • Regulatory Operations
  • Regulatory Information Management

Webinar Overview:

This session focuses on how the Regulatory Operations (RegOps) function is evolving driven by several technology and regulation factors. It will reference several large Regulatory and AI / Automation studies by Gens & Associates coupled with extensive experience working with organizations to answer:

     - What will RegOps look like in 2030 (skills, roles, remit).
     - What is real vs hyped to AI/Automation impact on RegOps.
     - How does the Evolving Regulatory landscape influence business considerations for AI/Automation.

Presenters:


Danielle McVey, Director, Regulatory Innovation & Compliance Excellence

With a strong foundation in people management, Danielle began her career developing and leading teams to their highest potential. Transitioning into the pharmaceutical regulatory field, Danielle started as a Regulatory Submission Specialist, quickly advancing to managerial and leadership roles. Driven by a passion for continuous improvement, Danielle moved into strategic initiatives, focusing on Program & Change Management. Danielle has led numerous change management workstreams, developing strategies to facilitate smooth transitions and foster a culture of adaptability.

Throughout Danielle’s career, she has demonstrated a commitment to excellence, a keen aptitude for learning, and a dedication to achieving improved results. Danielle’s journey blends people management expertise and strategic leadership in the pharmaceutical regulatory domain, with a strong focus on change management in Regulatory Innovation.