Dr. Deepak Rai serves as a Principal Medical Advisor in the Prescription Medicines Authorisation Branch of the Therapeutic Goods Administration (TGA), Australia, and is based in Sydney. He is formally trained in paediatrics and clinical leadership, holding qualifications including MBBS, MD (Paediatrics), DCh,, as well as a master’s degree in clinical leadership and management. Dr. Rai has a strong interest in academic research, with over 50 publications to his name. He is actively engaged in collaborations with international regulatory bodies such as the EMA, WHO, ACCESS, and ICMRA, and serves as an EMA Open Expert. Additionally, Dr. Rai represents the TGA at ICH Working Group 23, which is responsible for developing ICH guidance on the use of real-world evidence in medicine regulation.