A preview of DIA’s upcoming Regulatory Conference, where ArisGlobal will unveil its revolutionary regulatory information management system software.
It’s no secret, the main role of any pharmaceutical company’s regulatory affairs (RA) department is to interact with the regulators of different countries throughout the development, registration and marketing phase of the product life cycle – all with the goal of meeting compliance and getting the approval needed so that clinical trials can be conducted and products can be manufactured and safely marketed. And, behind the scenes, RA must ensure that information is collated from different departments in the organization and that the required information is shared with the health authorities. But why do the regulations shifting have to cause such difficulty? Why do pharmaceutical companies end up with such a complicated, hornet’s nest of systems?
Do these challenges sound all-too familiar?
Given this reality, companies need to focus on being ahead of the audits and building internal mechanisms and procedures to ensure that compliance is achieved. Regulatory departments not only have to focus on collecting and sharing information with regulators, but also need to look at the needs of their internal customers.
Not a complete list by any means, but challenges in this area include:
- An increasing stream of requests for publishing information which is approved
- Proactive sharing of planned information on upcoming approvals and timelines
- A more agile approach to sharing the approved information with other departments
- Interactions with different authorities, requiring preparation for, and managing to, changing regulations such as IDMP
- Finding an intelligent way to get the participation of affiliates in the regulatory information management process
This all may sound practical – but execution, we all know, is a different thing. But, at ArisGlobal, we have a different take on how to solve this problem.
If these challenges sound familiar, we encourage you to meet us at the DIA Regulatory, Submission, Information and Document Conference (Booth #102) where our regulatory experts will be there to share how our suite of solutions – regulatory information management system software (RIMS) and compliance management (xEVMPD, IDMP) software – integrates compliance with business processes over the entire product management lifecycle.
On February 6, we will be announcing an exciting, innovative regulatory information management solution at this show, so be sure to watch this space for more details.