Securing new drug development by establishing and maintaining phase-appropriate RSM designation from development to commercial launch

Gain clear guidance on phase appropriate RSM designation and adaptive RSM strategy for the overall API development roadmap. These solutions will mitigate both quality and regulatory risks, thus increasing the chance of success in IND and NDA filing.

Register free: https://www.pharmtech.com/pt/rsm-designation

Event Overview:

This webinar will discuss WuXi STA’s practice on overall RSM strategy, focusing on:

• Starting material evolution
• RSM designation
• Risk mitigation for potential regulatory push-back

The audience can expect clear guidance on phase appropriate RSM designation and adaptive RSM strategy for the overall API development roadmap. These solutions will mitigate both quality and regulatory risks, thus increasing the chance of success in IND and NDA filing.
Key Learning Objectives

• Understand material evolution
• Learn the appropriate RSM designation
• Mitigate risk for potential regulatory pushback in late-stage new drug development

Who Should Attend

• Pharmaceutical Manufacturers
• Drug substance supplier
• Biotech innovators
• Pharmaceutical chemists

Speakers

Melody Mak-Jurkauskas
Senior Director CMC Regulatory Affairs
WuXi STA, a subsidiary of WuXi AppTec

Melody Mak-Jurkauskas, Ph.D., is the Senior Director of Reg CMC Regulatory Affairs, responsible for all regulatory aspects of CMC. Her group provides STA’s clients with the preparation of regulatory filings, assistance during interactions with health authorities, and the development of robust global regulatory strategies to ensure uninterrupted clinical studies and successful marketing applications. Dr. Mak-Jurkauskas joined STA in 2019 with over a decade of expertise in analytical development, and drug substance and product manufacturing. Dr. Mak-Jurkauskas earned her Ph.D. degree in Physical Chemistry at Brandeis University under the guidance of Professor Judith Herzfeld and her Bachelor of Science in Chemistry at the University of Toronto.

Jianhua Wang
Vice President Late-stage API
WuXi STA, a subsidiary of WuXi AppTec

Jianhua Wang is Vice President of Late-stage API and has more than 10 years of experience in innovative drug development, specializing in CMC project management. Prior to joining STA, he worked at Evonik Industries AG (Hanau-Wolfgang) and Novartis Pharma AG (Suzhou) as project manager and development unit head. Jianhua holds a Ph.D. degree in Chemical and Biological Science from Scripps Research Institute (La Jolla) and an MBA degree from Peking University.

Register free: https://www.pharmtech.com/pt/rsm-designation