Joerg Putzke1, Scott Haughie2, Kelly H Zou3, Gopinath M Ranganna4. 1. Product Safety and Risk Management, Viatris, Freundallee 9A, 30173, Hannover, Germany. Joerg.Putzke@viatris.com. 2. Biometrics, Global Clinical Operations, Viatris, Kent, UK. 3. Medical Analytics and Real-World Evidence, Viatris, Inc., Canonsburg, PA, USA. 4. Global Clinical Development, Viatris, Bangalore, India.