Join us as case studies are used to highlight the spectrum of getting a drug to market, focusing on regulatory affairs from facilities, manufacturing, quality aspects, submissions, and product launch.  Our panelist have experience with health authorities around the globe and will share lessons learned as key take aways for successfully getting a product to patients globally.

Yeeju Chen (Asia): Yee Ju Chen, B.Sc. (Pharm.), registered Pharmacist, Singapore. Is Managing Director & BD for Asia at PharmEng Technology. She brings with her a diverse pharmaceutical career spanning across community retail pharmacy, commercial merchandising, academia, executive training and engagement for the industry. Since 2015 at PharmEng Technology, she has developed and now leads a team of consultants supporting Regulatory Affairs, Quality Management Systems and Pharmacovigilance in various product categories from innovators to generics, biosimilars, medical devices, health supplements, cosmetics etc.  Her experience spans across regulatory intelligence, advisory and strategy, GDP Supplier and Pharmacovigilance audits, QMS set up and remediation, dossier due diligence and feasibility review, product registration preparation, submissions as well as life-cycle and project management. Together with her team, she supports clients from many parts of the world who seek to understand the regulatory and market entry needs into Asia. Ms. Chen’s insight into the pharmaceutical industry encompasses quality assurance and regulatory compliance, spanning from drug discovery to biomedical development, manufacturing and to market access. She has led undergraduate, postgraduate and professional training programs at the National University of Singapore’s Department of Pharmacy. Ms. Chen also brings extensive networks and commercial management expertise in product and inventory management, merchandising, branding, sales and marketing of FMCG and pharmaceutical products on both B2B and B2C platforms, contributing to the successful operational execution of businesses. She now leads the Regulatory Affairs team in South East Asia, overseeing various product registration projects across different product classifications, ranging from Biologics/Biosimilars to Pharmaceuticals to Medical Devices etc.

Kenny Peng (Asia): P.Eng., RAC, is a Masters graduate in Mechanical Engineering from the University of Waterloo, Professional Engineer (Ontario), and Regulatory affairs certified by RAPS. Broad technical experiences span multinational big pharmas, medical device manufacturers, domestic manufacturers, new drug manufacturers to generic and contract manufacturers in Canada, US, Taiwan, Singapore, Malaysia, Indonesia, Thailand, South Korea, Hong Kong, and China. Technical expertise in facilities (design, engineering, validation, hand-over, startup, GMP operations), product / process (chemical processes, biological processes, molding processes, sterilization processes, medical device processes), supply chain lifecycle (importer, exporter, third-party logistics, warehouses, GMP manufacturing, GMP secondary re-packaging, clinical laboratories), pre- and post-market regulatory affairs. Cross-border specialist in business development, trade/commercial/regulatory affairs works, and project management. Having lived, worked, and established businesses in North America and across Asia, and managed, and facilitated international projects to/from Europe, Asia, Australia, Africa, North America, South America. Commercial regulatory affairs works in food-and-drug regulations, establishment regulations, trade regulations, and labour regulations.

Mitchell Wheeler (USA): Mitchell Wheeler is a 33-year healthcare industry manufacturing professional with experience in operations, engineering, supply chain, compliance, quality assurance, which includes 11 years of consulting. His experiences include sterile and solid dose pharmaceuticals, biologics, combination products, medical devices (disposable, serialized and IVDs), supply chain mgt and nutritional product manufacturing.
He has supported FDA GxP, MHRA, MCA, ANVISA, TGA, EU MDR, ISO, MDSAP, DEA, NRC, OSHA, VAWD, State Board of Pharmacy, as well as other types of compliance inspections. Mitch is also a skilled quality improvement professional, facilitator, investigator, quality tools user, project manager and cross functional collaborator who has supported teams on the development of improvements.
He holds MS and BS Degrees in Manufacturing Technology from East Carolina University and North Carolina A&T State University, respectively. During his career, he has earned certifications as Quality Manager/Organization Effectiveness, Quality Auditor, Biomedical Quality Auditor and Pharmaceutical GMP Quality Professional through the American Society for Quality (ASQ).

Vagiha Hussain (Canada) Vagiha Hussain is a Managing Consultant at PharmEng Technology and a 22-year healthcare industry professional with experience in project & program management, validation, manufacturing, quality systems and operations, compliance and product launches. She has over 8 years of direct consulting and her experiences include sterile pharmaceuticals, biologics, imported drugs, medical devices and consumer healthcare products. She has both Conducted and Hosted Audits for FDA, Health Canada, GxP, ISO, customer, and performed supplier audits among other types of compliance inspections. She is a skilled quality management professional well versed in drug and device regulations with strengths in FDA Remediation & Responses, QMS remediation, Regulatory Review and Deviation and CAPA Management programs.  She has functioned in a managerial capacity throughout her tenure and a project manager who has worked cross functionally to support teams in site and system improvements. She has a proven track record in managing site validation activities with excellence in project execution in scope, on-time, meeting quality requirements and budget. Her experiences lie in existing and new facility expansions. Her experiences lie in quality management consultation, team building, professional development, strategic implementation, and company collaboration and holds a MSc and BSc Degrees in Chemical Engineering, specializing in Biotechnology from the Technical University of Denmark.