TayganPoint and Bluecrux organized a round table discussion on Resource Management in Regulatory Affairs departments. RA experts from Merck (MSD), GlaxoSmthKline (GSK), Johnson & Johnson, Covance and Gens and Associates gathered around the topic that was introduced by Apostolos Mamakis and Pierre Roussel from GSK Vaccines.
Based on their 2016 World Class Regulatory Information Management Survey of 54 RA departments, Steve Gens, Managing Partner at Gens and Associates, confirmed that Submission and Resource Planning is viewed as inefficient operationally and generally seen as an unmet need in the market. Several providers have very basic capabilities, but most sponsors end up using Excel based solutions which are not sufficient to cover the problem. Apostolos presented how they approached resource planning in their Global Regulatory Affairs department of about 400 people. Supported by Pierre, who is leading the demand and capacity management team, he explained the challenges, the change management and the advantages of Binocs as a resource management platform for their organization. These were summarized in five key success factors for a sustainable planning process:
- Minimize the demand data input through an innovative method to automatically generate accurate work sequences out of submission event data.
- Ensure that the resource management application is accessible around the globe and very easy to use by all users of the Global Regulatory Affairs department. That was one of the unique advantages of Binocs.
- Design a compelling balance scorecard of KPIs that demonstrate the improvements in resource utilization and planning adherence.
- Apply embedded change management during the implementation and hypercare period after go live.
- Deploy in waves of about six weeks duration and start a new wave every three weeks. This pace makes sure the implementation is not an endless mission on one hand, but on the other hand is not stretching the capabilities of the organization too much.
The case proved to be quite compelling for the audience and propagated a lot of interesting questions and discussion topics. We plan to repeat this event on September 22th. In case you are interested to join, just leave us a note. Suggested reading: