Minutes of the EUpALS Round Table 2026 on

Inclusion/Exclusion criteria in ALS clinical trials

Place: Hybrid meeting:

• In-person at Novotel Campo de las Naciones, Calle de Amsterdam 3, Madrid (Spain)

• webmeeting

Date: Monday June 22, 2026 ; 17h30-21h00 Madrid time

Minutes: Dirk De Valck (Staff EUpALS

1.Welcome (Evy Reviers, Chairwoman)

• Welcome on behalf of the EUpALS Board of Directors
• Highlighting the dedicated support of Novartis
• Briefly going over the agenda

2.Who attends? (Evy Reviers, Chairwoman)

• Short introduction of attendees to Round Table
  • EUpALS Industry Partners
  • EUpALS Member Associations
  • Representatives of the EUpALS Patients and Carers Expert Board

3.Retrospect to the EUpALS Round Table 2025 on Patient Reported Outcomes in ALS clinical trials (Evy Reviers, Chairwoman

• Presentation of the EUpALS Position Paper ‘Patient Reported Outcomes in ALS clinical trials’
• Thank you to the Working Group ‘Patient Reported Outcomes in ALS clinical trials’

4.Panel discussion on ‘Inclusion/Exclusion criteria in ALS clinical trials’

• Moderated by Evy Reviers (Chairwoman EUpALS)
• Panelists
  • Patient representatives
    • Ywan Dierick (EUpALS Patients and Carers Expert Board)
    • Josefina Garcia-Pastor (EUpALS Patients and Carers Expert Board)
  • Academia representatives
    • Prof. Leonard van den Berg (UMC Utrecht, EUpALS Scientific Expert Board)
    • Prof. Philip Van Damme (UZ Leuven, EUpALS Scientific Expert Board)
  • Industry representatives
    • Adria Martig (Biogen)
    • Eric Litjens (Prilenia)
    • Claudia Rocca Herms (Ferrer)
  • Regulatory representative
    • Elena Hernandez Martinez De Lapiscina (European Medicines Agency)

5.Questions and Discussion

• Moderated by Anne Jolie (ALS Liga Belgium)

6.Setting up Working Group ‘Inclusion/Exclusion criteria in ALS clinical trials’

• To write the according EUpALS Position Paper on ‘Inclusion/Exclusion criteria in ALS clinical trials’
• Presenting the time line of the drafting process
• Call to join the Working Group

7.Introduction to EMA public consultation

• Currently, EMA has opened a public consultation on a concept paper on the need for revision of the Guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis
• Feedback awaited by September 30 2026

8.Closing (Evy Reviers, Chairwoman)

With special thanks to the panelists and in-person attendees of the EUpALS Round Table 2026