Regulatory Intelligence: Distribution Methodologies Session Preview

 

One of the many experienced regulatory intelligence executives presenting at Q1’s first ever Life Science Regulatory Intelligence and Strategy Conference on October 18-19 in Arlington, VA is Daanish Ashraf, Global Regulatory Intelligence Lead at Biogen. His presentation, “Regulatory Intelligence Distribution Methodologies to Inform and Train Internal Stakeholders on Policies and Current Compliance Guidelines,” will cover many different approaches used by regulatory intelligence leaders to ensure companywide understanding of policies and compliance. Read more below for a preview of the methodologies!

 

Can you please give a quick summary of your presentation?

The presentation will focus on how best to distribute regulatory intelligence within an organization. I’ll discuss the research that has been done on how best to distribute information to internal stakeholders and how it has been applied at Biogen. I’ll then move on to case studies on what has been done at Biogen, what has worked, what has not worked and some best practices that we’ve learned. One case study will focus on our newsletter platform and how that works for us, why we created it and how we went about deciding how to develop it. I’ll discuss the benefits and drawbacks of outsourcing and the necessity of having internal people focused on regulatory intelligence distribution. Another case study will focus on various in-person meetings that can be held within regulatory departments and R&D groups to distribute information. I’ll cover how best to capture that information to turn it into content, such as webinars, that can be digested after the meeting. I’ll also cover the benefits of having different types of meetings for different types of information and why it’s better to distribute information in specific types of meetings, rather than distributing everything in one meeting.

 

Can you give one example of a case study or medium that is being used to train internal stakeholders?

The newsletter case study would start out with a problem statement, which is that within Biogen we thought the regulatory department, along with the entire R&D group, wasn’t aware of what was going on in the external regulatory landscape as much as they would like. However, the issue was that our team was small, and it was unclear whether we were staffed enough to handle the distribution of information ourselves. So, we looked outside and saw what vendors were available that could offer us help to accomplish what we wanted to do. I’ll speak on the criteria we were looking for in a vendor, what we were looking for when we were designing the newsletter and the entire process from front to end. To conclude, I’ll talk about its success, how we measure its use and how we’re constantly looking to see how we can improve the platform.

 

What do you hope is one thing attendees walk away from your presentation knowing?

I would say an understanding of how best to distribute regulatory intelligence regardless of how big or small an organization is.

 

Want to hear more from Daanish Ashraf on effectively delivering regulatory intelligence to relevant internal stakeholders? Join us for the inaugural Life Science Regulatory Intelligence and Strategy Conference on October 18-19 in Arlington, VA. For more details, download the full program agenda and reserve your spot by registering today!

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