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Dr. Shanti Marlina Sibuea, S.Si., Apt., M.Sc.
Ketua Tim, Pengawasan Produksi Produk Biologi Direktorat Pegawasan Produksi ONPP at Badan POMWith over 12 years of experience as a GMP inspector for Badan POM Indonesia, Dr. Shanti has acquired extensive expertise in pharmaceutical regulatory affairs, including Advanced Therapy Medicinal Products (ATMP) development and GMP-compliant facility establishment for ATMPs. Her inspections have covered a wide range of products, including vaccines, biosimilars, cytotoxic drugs, and hormones, from esteemed pharmaceutical companies in China, India, South Korea, Japan, and Puerto Rico. She has also served as a PIC/S assessor and a temporary advisor for the World Health Organisation (WHO), contributing to global initiatives in GMP and quality management systems in countries such as China, India, and Papua New Guinea.
Dr. Shanti is a recognized speaker at numerous prestigious events, including the PIC/S Expert Circle, GMP forums, conferences, training sessions, and workshops.
Her academic background includes a PhD from Monash University, specializing in stem cell research. Dr. Shanti’s research focuses on the development, maturation, and survival of pluripotent stem cell-derived midbrain dopaminergic neurons. She also holds a pharmacist degree from the University of Indonesia and a master’s degree in biopharmaceutical sciences from Leiden University. Her innovative Master’s project explored the use of micro- and nanoparticles for targeted vaccine delivery in cancer immunotherapy.
Hue Kwon
Member, RAQAB at Parenteral Drug AssociationDr. Hue Kwon served leads a global quality team providing GxP quality and compliance oversight for the end -to-end drug development and lifecycle.
Hue was the former Vice President and Quality Team Leader at Samsung Bioepis, and prior to joining Samsung Bioepis, she was the Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus.
She also served as a senior advisor consultant in regulatory strategies for multiple organizations and global matrix environment and for digital health strategy, global IT and global operational alignment project in drug development.
Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.
Peter Qiu
External Advocacy Lead, APAC at Roche GenentechDr. Peter Qiu is the External Advocacy Lead for Asia Pacific at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.
Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.
Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.
Richard Chai
Senior Technical Service Manager at STERIS CorporationRichard Chai is a Technical Service Manager in the Life Sciences Division of STERIS Corporation. He currently provides global technical support related to process equipment cleaning and contamination control in cleanrooms. Richard has more than 20 years of industry experience in manufacturing, validation and technical support. He has published several articles in contamination control and is a frequent speaker at industry events.
Somasundaram G.
Global Senior Consultant, Process Solutions at Merck KGaASomasundaram has more than 22 years of combined experience in the pharma & biopharmaceutical industry. He has a broad experience in the areas of Aseptic Processing, Down stream processing of Biologics, & Closed Processing.
Som, is currently Global Senior Consultant for Merck Life Sciences under the Process Solutions division based in Singapore. He has spent close to 20 years within Millipore & Merck in roles of increasing responsibilities. His previous tenure includes head of South APAC technology management, Validation Services, Technical Services & Sales Management.
Som currently is a Board member of PDA Singapore Chapter and ISPE India Executive Committee member
Somasundaram has Master’s degree in Microbiology & Business Management.
Dhanu Angga Kumara
Technical Application Expert at PT Merck Chemicals and Life SciencesDhanu Kumara is a Technical Application Expert in Single Use Technologies and Integrated Systems at Merck Life Science, where he supports customers across Southeast Asia, Pakistan, Australia, and New Zealand. In his role, Dhanu leads technical discussions, offering tailored solutions to customer inquiries and identifying opportunities for process optimization. He holds a degree in Biotechnology from the Netherlands and has gained extensive experience working in process development and manufacturing for various biotech companies in Europe. After returning to Indonesia in 2015, Dhanu served as the R&D Lead Scientist at Kalbio Global Medika. Since joining Merck in 2021, he has been dedicated to providing exceptional technical support and solutions to his clients.
Mira Mutia Meirani
Manager of Quality Risk Management & Contamination Control Strategy at PT Bio farmaBeginning my career in vaccine and sterile manufacturing in 2015 with previous experience in handling change control management, product complaints and recalls, and further experience in bio risk management has developed my comprehensive understanding of quality assurance processes. Currently, I am handling Quality Risk Management (QRM) and developing a Control Contamination Strategy in PT Bio Farma (Persero), my role involves evaluating and performing risk assessment and implementing strategies to maintain and enhance product quality and compliance.
Undi Suhartono
Head of Multiproduct Viral Bulk Production Department at PT Bio Farma (Persero)I have almost 15 years of experience in vaccines and life science products, with primary areas of expertise in product research, process development, technology transfer, developing a new product quality attribute, production upscaling, facility certification, product quality improvement, quality risk assessment, process validation, contamination control strategy, and the implementation of a quality management system in the commercial production area. Currently, I serve as the Head of the Multiproduct Virus Bulk Production Department in PT Bio Farma (Persero), which is committed to producing high-quality bulk nOPV2 and implementing its quality management system.