2 FEB: Pre-Conference Interactive Day - All Times CET

1:15 pm - 3:30 pm Pre-Conference Interactive ‘Coffee Club’ Discussion Groups

In this new digital world we need to find new ways to bring our communities together. We understand that interactive, real time discussion with your colleagues is one of the most valuable parts of any conference so we’ve adapted for the digital world!

So – brand new for SDMD 2021, our ‘Coffee Club’ networking discussion groups.

Choose your topic and enjoy cup of tea or coffee and strategy focused discussions with a small, select group of industry colleagues as you prepare for the next two days of conference!

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13:20 - 14:00 Table 1: Preparing and Managing Your Remote User Training and Qualification

Ramon Alonso, IT Compliance Lead, Grifols


14:05 - 14:45 Table 2: Risk Management and Quality Assurance under Covid – assessing the impact on device development and approval pathways

Celestina Bianco, Director - Quality Assurance and Regulatory Affairs, Werfen Clinical


14:50 - 15:30 Table 3: Mapping the Agile Rulebook For Right Now: Strategies to be Agile even under Covid!

Nancy Van Schooenderwoert, President and Principal Coach, Lean-Agile Partners, Inc

Brian Shoemaker, Principal Consultant, ShoeBar Associates

3:00 pm - 4:00 pm Content Break

Practices already in use at multiple regulated medical companies clearly show that discipline, determination, and organization in an Agile context have yielded great benefits. With Covid-19 encouraging new regulatory pathways and shining more light than ever on our medical software development, agile development provides an flexible toolkit for optimising your processes no matter the environment.


In this masterclass we will discuss case studies from companies who, after an initial program didn’t work as hoped, have rebuilt their Agile program with significant improvements to companies who have taken an agile approach from start to finish, generating compliant documentation as a natural outcome of development and minimise the risks of human error.


From this workshop, participants will learn real-world examples of:

* Improving judgment in applying Agile principles

* Methods to achieve compliance automatically under Agile

* Techniques to blend planning and iterative development


Discover how much you already know about how to apply systems thinking - by seeing some well-chosen examples, you’ll sharpen your judgment for choosing the right practice to serve Agile principles in your "unique context"

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Nancy Van Schooenderwoert

Principal Consultant
Lean Agile Partners

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Brian Shoemaker

Principle Consultant
ShoeBarr Associates