CRED ERP 25

applications including, but not limited to, MAAs, BLAs, IND’s, CTA’s, PIP’s, OD’s & numerous agency meetings for various types.

Ming Ewe Ming is passionate about unleashing a different kind of leadership in the biotech industry to improve the health and wellbeing of humankind. Over the past 25 years in global and European roles, Ming has helped various companies and startups develop their highly innovative drugs including cell and gene therapies (CGTs). She is well versed in handling complexity and ambiguity while helping organisations navigate the complex regulatory jungle and change within growing SMEs. Having frequently experienced how people and organisational issues can significantly affect the overall progress and success of a promising therapy, in some instances derailing entire programs, Ming firmly believes that a more integrative strategic approach is sorely needed. The more aligned your regulatory strategy, organisational and people are, the more likely the right regulatory strategy will be successfully identified and implemented. Ming is currently a mentor on the Bioindustry Association’s (BIA) Women in Biotech mentoring program. She is an active member of The Organisation for Professionals in Regulatory Affairs (TOPRA) where she is the Co-Chair of the Combination Products Special Interest (SPIN) group covering Drugs and Devices/Companion Diagnostics and helps to train young regulatory professionals. Ming now exclusively works with innovative purpose-led early-stage biotech start-ups Sahana Rajashekar With a background in Regulatory Affairs and Biotechnology, having graduated with a Masters in Regulatory Affairs from University of Southern California, Los Angeles in 2017. Sahana works as a Senior Regulatory Affairs Specialist II in Kamet Consulting Group. She worked as a Regulatory Affairs Specialist in Cooper Vision and dons a 510K Submission to the US FDA (K23427) under her name. She has also interned in companies such as Philips Healthcare, Seattle and Foundation Medicine, Massachusetts. She has also worked as Clinical Research Specialist for All of Us Clinical Research Program. She has worked in the field of Pharmacovigilance as a Drug Safety Associate for a CRO by name IQVIA. She has experience in a start up , mid sized and established companies. This provides her with a wide and extensive knowledge of the Regulatory affairs field. through her consultancy, Smarter Biotech Solutions. LinkedIn: https://www.linkedin.com/in/ming-ewe/ Website: https://www.smarterbiotechsolutions.com/