Archives for May 2022

Interview with Andrew Thomson

What is extrapolation?
How can we use extrapolation in paedriatics?
What are the main challenges?

Paedriatic research always comes with challenges and understanding paedriatic submission is very important. There’s always a lack of treatment in this area. In this episode, you’ll understand what you can do to get evidence through extrapolation for the children population.

Stay tuned while Andrew and I talk about the following:

Why are we raving about this conference?
Why is this the best conference I have been attending?
What are the other activities beside the scientific part of the conference?

This is a special episode while Benjamin and I talk about the upcoming PSI conference and what you can expect from it. This will be a face to face conference in Gothenburg, Sweden!

Here are some of the points we talked about:

Interview with Rachael Lawrance

The FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making.

In today’s episode, we discuss the process with the FDA publishing a timeline of planned public workshops, draft guidance documents and final guidance documents for 4 documents, originally planned to finish in end 2021 and its objective to explore the factors that need to be considered when developing COA-based endpoints.

Stay tuned as we also talk about the following points: