Jesper Kjær

Company: Danish Medicines Agency

Job title: Director of Data Analytics Centre

Seminars:

Benchmarking the Progress of the EMA’s Data Analysis & Real World Interrogation Network (DARWIN) to Gain Insights into the Evolving European Health Data Space 4:00 pm

• After its first year of establishment, what are some of DARWIN’s early learnings? • How is the EMA utilizing RWE to support regulatory decision making? • How can regulatory bodies learn from eachother to harmonize guidances related to RWE?Read more

day: Conference Day One

Panel Discussion: Working Together to Harmonize the Global Regulatory Landscape for Utilizing RWE in Regulatory Submissions 2:00 pm

What do we need to see from industry collaboration bodies to achieve international harmonization around RWE?  What challenges are currently being faced by the pharmaceutical industry across the product lifecycle (regulatory and HTA) due to heterogeneity in guidance's.  What will it take to harmonize these processes and align globally? Read more

day: Conference Day One