Emily Cheah
Senior Managing Director of Charles River LaboratoriesA pharmacist by training, Emily is currently Senior Managing Director of Charles River Laboratories Singapore (Microbial Solutions) and APAC Technical Operations Lead. Emily oversees the APAC laboratory operations, as well as site operations including R&D / Centre of Excellence, and market development operations. She oversees technical programme roll outs in APAC and is involved in the evaluation and implementation of new technology & services within the Microbial Solutions division and serves on various committees within the company.
She received her Ph.D. (Pharm. Technology) from the National University of Singapore and her EMBA from INSEAD.
Emily is one of the founding members of the PDA Singapore Chapter and has served as a Board Member in various capacities since its inception in 2013. Emily is the current President of PDA Singapore Chapter.
Gabriel Gori (Invited)
Chair, Science Advisory Board at Parenteral Drug AssociationGabriele Gori has been in the sterile Pharmaceutical/Vaccine/Medical Device business since 1994 – in different local and global roles in multinational companies, including, Bausch & Lomb, Chiron, Novartis, GlaxoSmithKline, Thermo Fisher Scientific, Zambon and Biogen. His experience covers R&D, Engineering, Validation, Quality Control, Quality Assurance, GXP Compliance and Auditing, Quality Operations and includes senior roles e.g. Global Head of Quality for Zambon and Biogen, and the leading of teams of more than 500 associates located in multiple countries across the globe. Currently Gabriele is providing support to the Pharma and Medical Device industry as a consultant. Sterility Assurance and GMP Compliance expert, Gabriele is currently the Chair of the Science Advisory Board (SAB) of the Parenteral Drug Association (PDA): invited speaker in international conferences and workshops on topics dealing with Aseptic Processing, Quality Systems and GMP Compliance, he also provided training to inspectors of European National Health Authorities. He has been further supporting the Industry concerning the review and commenting of the revised EU GMP Annex 1 by co-chairing a dedicated PDA Subject Matter Expert team. Gabriele holds a bachelor in Chemistry (University of Florence – Italy) and a master in Quality Management (University of Pisa/Consorzio Qualital – Italy).
Brooke Higgins (Invited)
Senior Policy Advisor for the Global Compliance Branch 3, CDER at US FDABrooke K. Higgins is an Acting Branch Chief and Senior Policy Advisor for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance (CDER/FDA). In this role, Ms. Higgins oversees the review of domestic and international pharmaceutical cases and handling of associated regulatory actions. Ms. Higgins has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, she spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, Ms. Higgins continued performing drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate in 2009, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.
Won Min Kim
Assistant Manager, Bio-Process Team at Green CrossWon Min Kim is the Leader for GC Biopharma’s Drug Product 2 team, manufacturing department which specified for Visual inspection (AVI, MVI) process and packaging process.
In his current role, he is responsible for establishing and maintaining AVI & MVI data such as AVI validation & MVI Qualification. He is also responsible for Vial packaging machine (1 Multi-packaging line & 1 Single Packaging Line). He set up new vial auto inspection machine from Koerber and entire manual inspection procedure and executed entire whole Validation not only initial validation but also regular validation or additional validation after change control.
He joined the company in 2022 as an experenced AVI engineer from Celltrion Pharm, in charge of maintaining the hardware and software of the company’s equipment. In Celltrion Pharm, he was mainly responsible for establishing & maintaining Syringe Auto inspection machine. He was also responsible for establishing & executing validation for part washer & auto-clave & Laminar flow hood.
Hue Kwon
Member, RAQAB at Parenteral Drug AssociationDr. Hue Kwon served as a Vice President and Quality Team Leader at Samsung Bioepis since April 2020. She leads a global quality team providing GxP quality and compliance oversight for the end -to-end drug development and lifecycle.
Prior to joining Samsung Bioepis, she served as 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.
Niraj Mehta (Invited)
Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD
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.
Peter Qiu 博士は、Roche Genentech のアジア太平洋地域の外部アドボカシー リードであり、米国 FDA で 13 年以上の勤務経験があります。 彼は CDER の医薬品製造評価局バイオテクノロジー製造部門の部門ディレクターを務めていました。 彼は、CDER の生物製剤ライセンス申請の審査および査察プログラムの製造プロセス、施設、微生物管理の評価を主導しました。 Qiu 博士は、微生物管理と無菌性保証評価、さらにはバイオテクノロジー製品の認可前および承認後査察に関する広範な知識を持っています。 Qiu 博士は南カリフォルニア大学を卒業し、博士号を取得しました。 生物科学の博士号を取得。