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Clinical Trial Events
DIA Europe

Talk DIAlogue Sessions track

S1105 - Startup Accelerator

Tue, Mar 18, 2025 · 2:30–4:30 PM CET Delhi Room, Congress Center Basel

About this session

This session gives innovators the opportunity to learn about pathways to communicate effectively with Regulatory Authorities and HTA bodies and discuss challenges in the development of innovative healthcare products. Industry experts, Regulators, HTA Body representatives and patient advocates will share insights into overcoming regulatory hurdles and the benefits of early collaboration in fostering specialised drug development.

Complementary* registration for startups. Healthcare startups looking to accelerate their journey and make a real impact in life sciences are invited to join this interactive session.
*complementary pass for this session and the first day of DIA Europe 2025 (1 pass per company).

Contact Edyta.Maciolek@DIAglobal.org
Learn more

Programme:
- 2. Empowering Small and Medium Enterprises in Specialized Drug Development: Navigating Challenges and Unlocking Opportunities — Anke Arnold-Tugulu
- 8. End Game Thinking - Navigating Regulatory and HTA requirements to develop products which serve patients, regulators and payers alike — Markus Kalousek
- 3. Regulatory pathways — Falk Ehmann
- 4. Clinical Trials — Marianne Lunzer
- 5. HTA — Anja Schiel
- 6. Digital Health — Gurmit Sandhu
- 7. EU funding — Elmar Nimmesgern
- Q&A and Roundtables — Falk Ehmann
- 1. Setting the scene — Falk Ehmann

Speakers

  • Marianne Lunzer

    CTCG Chair · AGES MEA

    Moderator

  • Anke Arnold-Tugulu

    Chief Regulatory Officer · Azafaros B.V.

    Speaker

  • Falk Ehmann

    Head Innovation and Development Accelerator · European Medicines Agency

    Chair

  • Markus Kalousek

    Venture Partner · BioGeneration Ventures

    Speaker

  • Gurmit Sandhu

    AI Practitioner in Healthcare · Gurmit Sandhu Consulting GmbH

    Speaker

  • Anja Schiel

    Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA · Norwegian Medicines Agency (NoMA)

    Speaker

  • Elmar Nimmesgern

    Innovative and Personalised Medicine Unit · European Commission

    Speaker

  • Ursula Busse

    CMC Regulatory Affairs Advisor · Self Employed

    Moderator

  • Monique Al

    Special advisor sr · CCMO, Then Netherlands

    Moderator