CORS annual conference 2022

Copenhagen Centre for Regulatory Science is pleased to announce its 8th Annual Conference.

Real-world data – Let’s make it real!

When: 07.11.2022
Where: Nielsine Nielsen Auditorium
Blegdamsvej 3B
2200 København N
Denmark

Registration: closed

What: Program

The conference is a unique platform for discussion and debate for a wide range of experts (academia, regulators, industry, and patient representatives). We are committed to preserving the good tradition from the previous years and making this year’s conference again a success. CORS aims to focus on state-of-art development in regulatory science, bringing together different perspectives and expertise.

For this year's annual conference at CORS, we turn the spotlight to implementing Real World Data (RWD) use in a regulatory context.
The opportunity to use RWD has long been debated among regulators, industry, and academia alike, with all its strengths and weaknesses.
The debate has now moved beyond whether RWD should be used - this is now more or less a given, as expressed in the recent ICMRA statement on the topic.
The question now is how? Which question can be addressed by evidence from RWD? Which methodologies ensure that RWD use is trustworthy, and when may RWD be regarded as Real World Evidence (RWE)? How can the public trust that RWE-based decisions are robust? And how can we increase representativeness in the datasets to ensure that the data used for decision-making also reflect the populations in which the therapy will eventually be used?

These will be the questions addressed by the impressive lineup of internal speakers - all international experts in their field across industry, academia, and regulators.

Confirmed speakers so far:

Peter Arlett – European Medicines Agency (EMA), London, UK
Jesper Kjær – Danish Medicines Agency (DMA), Copenhagen, Denmark
Britta Hänisch – Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
Sebastian Schneeweiss – Harvard Medical School, Cambridge, USA
Pernille Brok Nielsen – Herlev and Gentofte Hospital, Denmark
Alison Cave – Medicines and Healthcare products Regulatory Agency (MHRA), London, UK
Nigel Hughes – Janssen, European Health Data & Evidence Network (EHDEN), Belgium
Chris Holmes – University of Oxford, UK
Erin Evelyn Gabriel – University of Copenhagen, Denmark

We look forward to welcoming you to Copenhagen for an exciting day of discussion on one of the hottest topics in today's scientific debate surrounding Drug regulation.

The conference is open for attendance by all interested parties.