Maximizing the business outcomes of IDMP compliance: Sun Pharma’s RIM-related ambitions
At BE THE EXPERT 2023 this month, I will share insights into the benefits his company expects to derive from IDMP compliance, as it moves towards the final go-live for its holistic RIM platform in December.
It can be so tempting to focus on the mandatory priority of new regulatory standards, but the shift from document-based regulatory submissions to something much more inherently data-based offers pharma companies a real chance to change their internal working practices for the better.
Implementing a good, holistic regulatory information management (RIM) system is becoming increasingly essential for pharma companies, because of the way regulatory processes will be managed in future.
But the scope for change is actually much greater, as companies look beyond compliance to the opportunities that arise once they have improved data quality and integrity; and as collaboration and communication (e.g. around change management) becomes much easier – once there is a centralized platform and there are agreed data standards.
Why stop at Regulatory Affairs?
The EU’s adoption of ISO IDMP data standards is the prompt all companies need to overhaul their internal processes. If, as an industry, we don’t embrace this opportunity, we risk missing out on a whole range of productivity and efficiency gains – not to mention the chance for increased market competitiveness.
At Sun Pharma, we’re extending the benefits of our investment to regulatory information management, pharmacovigilance and patient safety monitoring across the whole lifecycle of our products, using our Amplexor holistic RIM platform as the vehicle to track and manage all of this evolving information as it comes in.
It is important to be prepared for all the resources that will need to be allowed for in terms of time, technology and expertise, to properly plan and implement an effective end-to-end RIM platform, but the potential long-term benefits will more than justify this investment.
The view from here
Our own end-to-end RIM platform implementation continues. We had our first, technical go-live in December 2022 for the designated new applications, and we expect to complete our data migration phases by this coming December.
At BE THE EXPERT this month I’ll be talking through our experiences of our Amplexor deployment to date, from how we set our ambitions and scope for the project, to where we’ll be looking for the wider benefits – and how we expect these to translate into sharper market competitiveness.
It’s inevitable that complying with IDMP (not just in Europe, but in the US market too as the FDA embraces its own take on the standards) is going to add complexity – initially, in terms of the data transformation work that’s needed, and what that means for current processes. But the potential gains are substantial.
Having a centralized platform to track and manage everything definitively – data which by now is robust, consistent and reliable – will be an immense asset for pharma companies, from now right into the distant future. It will enable the different pharma functions to be sharper and more timely in their decisions and actions, which in turn will help them strengthen and enhance their market position.
I hope to see you at my session (or that you’ll view it online), where I’ll be going into more detail about our decision process, our implementation plan, and our hopes and expectations once we’re fully up and running on our new holistic RIM platform.
- Satappa Kambale, based in Mumbai, India, is a Regulatory & Business Continuity professional at Sun Pharmaceutical Industries Limited.
- At BE THE EXPERT 2023, he will discuss his company’s broader hopes for IDMP compliance and more structured regulatory data management, as Sun Pharma enters the final stages of its migration to a holistic RIM platform from Amplexor.
Discover our Life Sciences solutions
Connect with us today!
Managing Partner of Gens and Associates
About the author
Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., A Life Science benchmarking and advisory firm specializing in performance improvement, strategy, regulatory information management, and organizational transition. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he led global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton.
His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor of Science in Business Computer Science and a Master in Organizational Development. He is a frequent speaker, has many publications, and was named to the 2017 PharmaVoice 100 and as an innovator in the 2021 Innovations in Pharmaceutical Development™ for his contributions to industry.