Navigating Risk and Change - Day 1

Cloris is a Senior Regulatory Expert, China. She holds a Master’s degree in Biological Sciences and has over 20 years of experience in biologics R&D, product registration, and regulatory affairs across pharmaceuticals, excipients, food additives, chemicals, and life sciences. Cloris specializes in monitoring global regulations, strategic analysis, and regulatory training. She has served multiple terms on the IPEC Federation board and currently chairs IPEC China.

Ulrich leads a global team supporting regulatory compliance for manufacturing active and biologic drug substances, including site registrations worldwide. With over 25 years of experience in regulatory and quality roles, he holds a PhD in Medicinal Chemistry and a Master in Drug Regulatory Affairs. Ulrich chairs the IPEC Europe Nitrosamine Task Force, participates in ICH and European Pharmacopoeia expert groups, and serves on the pharmacopoeia committee on medicinal chemistry at BfArM.

Yuwei holds a Master’s degree in Chemistry and Drug Regulatory Affairs and has nearly two decades of experience in the global registration of APIs, excipients, and drug products. She possesses deep regulatory expertise in GMP requirements for pharmaceutical raw materials and worldwide product registrations. She is an active member of the European APIC Working Group on Emerging Markets, M4Q(R2), the China Task Force, and the German Regulatory Affairs Association (DGRA).

Simone specializes in Single-Use Technology and filtration within biopharmaceutical manufacturing. She provides regulatory guidance to diverse stakeholders and has helped many drug manufacturers successfully implement Single-Use Technology. Her main focus is to ensure product performance meets quality and regulatory standards. Simone is an active member of the Parenteral Drug Association (PDA) and BioPhorum. She holds a Ph.D. in Microbiology from the University of Frankfurt.

Manisha Chaudhari is a pharmacist by education & has done Master of Pharmacy specialization in Drug Delivery technology from Institute of Chemical technology, Mumbai. She has more than 14 years of experience in the field of business development and technical marketing of excipients & API. Her areas of expertise include solubility & bioavailability enhancement.
Currently she is leading a team of Technical Application Experts, Excipients, APeC.

Kyung-min Shin has over 20 years of experience in drug formulation research and marketing/customer applications. He has expertise in various pharmaceutical development areas, including New Chemical Entity (NCE) projects, Incrementally Modified Drugs (IMDs), and Co-development (C&D) projects. Currently, he works as a Customer Application Consultant, where he offers customized solutions for challenges in drug formulation development. He also advises on the selection of pharmaceutical raw materials for both classical and biopharmaceutical industries.

Bennett holds a Master of Chemical Engineering from Imperial College London and an MBA. He brings over a decade of expertise in business development, marketing, and partnership strategy. Since joined Merck Life Science in 2022, he has played a key role in developing and executing go-to-market strategies for single-use and integrated platform solutions in bioprocessing across APAC. Working with product managers, R&D and technical experts, he delivers tailored, innovative solutions that help biopharmaceutical customers accelerate development and delivery of life-saving therapies.