Notice: this event has taken place on April 11, 2023 15:00:00. You can no longer sign-up for this event.

Johnson & Johnson Innovation event: Regulatory Approaches in Novel Technologies and Methods (ENG)

Event summary

It may seem a distant spec on the horizon, but at some point all innovators will want to submit their potential healthcare solution for regulatory approval. This can be a long and winding road, especially when submissions include novel technologies or innovative clinical trial setups. It can be disappointing, frustrating, and costly if regulatory approvals are delayed because expectations were unclear. So, why not start at the end? Familiarize yourself with what regulators may need and work back to design your procedures and strategy.

Innovators are invited to join this Johnson & Johnson Innovation – JLABS program which focuses on learnings that may help them smooth their regulatory approach. Johnson & Johnson experts and guest speakers will share their insights on regulatory aspects of disruptive innovations.

  • Jasper Renz, Sr. Director Regulatory Affairs at Vico Therapeutics B.V., will kick off with an introduction on regulatory strategy for innovative technologies, focusing on specific opportunities for small and emerging companies
  • Julia Tillkes, Global Regulatory Leader of Oncology at Janssen Biologics B.V., will elaborate on procedures and obstacles for using biomarkers as validated measures of efficacy.
  • Pieter Luchtenburg, Regulatory Affairs Liaison at Janssen Biologics B.V., will discuss potential implications for regulatory submissions when remote monitoring is used in clinical trials.
  • After, a panel of experts will share insights and discuss the regulatory landscape from different angles.

This session is hosted in Amsterdam. The general focus of the session will be on EMA submissions for pharmaceuticals. Where possible they’ll share insights that are relevant globally.


The venue will be the “Crowne Plaza Hotel, Amsterdam – South”, located within walking distance of Amsterdam Zuid train station and also a stone’s throw away from the EMA offices.

What to expect?

  • 14:30 CEST | Registration opens
    • In-person attendees only
  • 15:00 CEST | Introduction to Johnson & Johnson Innovation
  •  15:15 CEST | Regulatory strategy and procedures for innovative technologies
    • Jasper Renz, Sr. Director Regulatory Affairs, Vico Therapeutics B.V.
  • 15:30 CEST | Validation and approval of biomarkers
    • Julia Tillkes, Global Regulatory Leader Oncology, Janssen Biologics B.V.
  • 15:45 CEST | Development of novel clinical endpoints using digital health technologies
    • Pieter Luchtenburg, Regulatory Affairs Scientist, Janssen Biologics B.V.
  • 16:00 CEST | Short break
  • 16:10 CEST | Panel Discussion
    • Vera Nies, Program Manager, Lygature*
    • Jasper Renz, Sr. Director Regulatory Affairs, Vico Therapeutics B.V.
    • Julia Tillkes, Global Regulatory Leader Oncology, Janssen Biologics B.V.
    • Nynke Ligtenberg, Clinical Development Leader, Janssen Vaccines & Prevention B.V. (Moderator)
  • 17:00 CEST | Extended Q&A
    • In-person attendees only
  •  18:00 CEST | Close

*) Final confirmation pending

Event organizer

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Johnson & Johnson Innovation