Regulatory Affairs and Clinical Challenges
Regulatory affairs and clinical challenges play a critical role in ensuring the safety, efficacy, and quality of regenerative medicine products. This session will examine global regulatory frameworks governing stem cell therapies, gene editing technologies, biomaterials, and tissue-engineered products. Participants will gain insights into clinical trial design, ethical approval processes, Good Manufacturing Practice (GMP) compliance, and post-market surveillance requirements. The session will also address key challenges such as regulatory harmonization across countries, approval timelines, and safety assessment of advanced therapies. Discussions will include risk management strategies, patient safety considerations, and evolving guidelines for novel regenerative technologies. By bringing together regulatory experts, clinicians, researchers, and industry professionals, this session aims to facilitate a clearer understanding of the regulatory landscape and support the smooth translation of innovative therapies into clinical practice.