Process Map

The ATMP process map aims to clarify which aspects must be addressed at each stage of ATMP development, and by which expert stakeholders. The resource is intended to support developers in assembling teams with the appropriate competencies to address all elements of development at the right time. In doing so, it seeks to proactively highlight considerations that are often only recognized in retrospect as “needing to have been addressed earlier.

Find the complete stakeholder specific process maps below:

Clinical Process Map

Healthcare Roles

Commercial Process Map

Business Aspects

Manufacture Process Map

Quality and CMC

Regulatory Process Map

Ensuring Compliance

Origins & Contribution:

The process mapping initiative originated in 2020, following the observation that different Swelife–ATMP projects were using varying terminology to describe ATMP development. In several cases, resources were developed as “X for ATMP,” without clearly reflecting the need for contributions from multiple expert stakeholders to fulfill those activities. Development started in 2021, with many individual contributors.

Contributors:

  • Anders Kvanta
  • Helder Andre
  • Per Ljungman
  • Aud Solvberg
  • Heidi Ekelund
  • Dag Larsson
  • Pontus Blomberg
  • Michael Wagner Christiansen
  • Miriam Idar
  • Sharon Longhurst
  • Ida Duprez
  • Luisa Lundin
  • Björn Skölving
  • Joanna Applequist
  • Jan Talts
  • Catharina Brandsten
  • Ulrica Eistrand
  • Angelica Loskog
  • Martina Johannesson
  • Axel Ståhlbom
  • Jenny Gustafsson
  • Juliana Kovacka
  • Adam Wegelius
  • Jozsef Vasi
  • Alexandra Patriksson
  • Kinga Täckström
  • Ola Tuvesson

We sincerely thank our all contributors for their engagement and commitment!

Please note:

This resource is designed to introduce key concepts rather than provide product-specific guidance. It is intended to be a living resource that will evolve over time, therefore  your feedback is welcome.

Please submit feedback related to a specific stage and stakeholder via the following form:
https://forms.gle/RrCq9UEhS3YpZx2z5