Business Transformation and CTR Lead, DLRC Ltd, DLRC Group

James’s journey with the EU CTR started in 2017, working at the EMA in the CTIS business team. Over the last six years, he supported the development of the regulation and guidance, the development of CTIS, and has supported clients with CTR readiness and CTA submissions. He has supported numerous clients in getting them ready for the CTR Go-Live through training, redesign of operating models, and updates to processes and procedures. More recently, he supports clients with strategic direction for trials submitted under the CTR and helps to navigate EU CTR guidelines and ensure CTA document compliance with the regulation.

Managing Director & Head of Regulatory Affairs, Orphix Consulting GmbH, DLRC Group

Wafa is a global regulatory professional with a broad experience across various therapeutic areas including rheumatology, anti-infective, dermatology and oncology. With her strong scientific, regulatory, and managerial expertise she successfully led both early development projects (CTA and IND submissions) and full development programs (MAA and NDA/BLA). She has supported clients with several investigational products through their European regulatory journey, advising on CTA requirements from a strategic perspective. She also acts as the EU legal representative under CTR and helps companies ensuring compliance with the new regulation.