From chemicals to consumer goods to cosmetics, most industries’ regulatory landscapes are becoming increasingly complex. Heightened scrutiny and restrictions across key markets like China and the EU are expected to continue through 2019 and beyond.
Keeping pace with this ever changing landscape is already a strong suit for most high performing regulatory professionals. The new twist is maintaining this adaptability while regulatory moves from the excel and paper-based systems they’re accustomed to, to cloud-based management systems that are increasingly required for efficient collaboration and traceability.
I remember preparing those enormous paper copies of submissions
that were just mountains and mountains of folders; now of course
submission management has evolved and electronic submissions through
various gateways exist.
- Aman Khera, Head of Regulatory Strategy, PRA
For many regulatory professionals, this shift from paper or on-premise software to cloud can be intimidating. Excel and paper are what you know, even if it is slow and cumbersome.
2019 is looking increasingly likely to be the year that resistance to technology change in areas like regulatory is overpowered by business demands.
“There is pressure to ensure alignment of regulatory affairs strategy, people, processes, data and technology with the rest of the organization to ensure data transparency and enable the company to be truly insights-driven,” reflected Pratyusha Pallavi at the eRegulatory Summit. “But in order to have data at their fingertips, regulatory affairs needs a technology solution that can access data across the product life cycle.”
To better prepare yourself and your team for the changes regulatory will face in 2019, download your copy of our report “Quality and Regulatory Professionals: 4 Trends that Will Impact Your Role in 2019”.