31 May 2023 – The Real4Reg consortium, whose work aims to promote the use of Real-world Data (RWD) and Artificial Intelligence (AI) to support Regulatory and Health Technology Bodies in their decisions on the life cycle of medicines, had their first hybrid meeting in the Danish capital city.
The gathering brought together all consortium partners and advisory board members for productive discussions and presentations on the progress of the work packages and was hosted by the Danish Medicines Agency (DKMA) in collaboration with the Consortium coordinator, the Federal Institute for Drugs and Medical Devices (BfArM).
This consortium meeting featured a diverse range of activities aimed at fostering collaboration between partners and addressed the challenges of the use of real-world data to support regulatory decisions about medicines.
The agenda included comprehensive reports on the progress of the six work packages. These reports provided valuable insights into the ongoing research and development activities within Real4Reg and showcased the consortium’s commitment to driving innovation on methods to support regulatory decision-making.
The meeting also featured breakout sessions, allowing participants to delve deeper into specific topics. These interactive sessions facilitated fruitful discussions, enabling the consortium members and advisory board to exchange ideas, explore potential collaborations, and collectively address the challenges faced in their respective areas.
An inspiring talk by guest-speaker Dr Sebastian Schneeweiss, Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics of the Department of Medicine at Brigham and Women’s Hospital, was also a notable highlight of the meeting. Dr Schneeweiss comprehensively covered an important topic, namely the use of real-world evidence (RWE), the importance of transparency and reproducibility of RWD analyses and approaches for AI methods in regulatory-grade RWE.
The Real4Reg Consortium expressed their satisfaction with the progress made during the meeting and emphasised their commitment to developing methods aimed at optimising the use of RWD in regulatory decision-making to benefit patients and society as a whole.