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.
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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
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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.
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We will discuss potential implications for regulatory submissions when remote monitoring is used in clinical trials.
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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, but where possible we will share insights that are relevant globally.
The venue will be the "Van der Valk Hotel Amsterdam Zuidas", located next door to the EMA offices and a stone's throw away from Amsterdam RAI train station.
Source: Johnson & Johnson Innovation