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From Digitalization to Early Planning: Key Trends Revolutionizing Life-Science Operations and Regulations
Understand Implications of Latest Amendment to MDR and IVDR published in March 2023
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Jie has more than 12 years’ experience in both global and local pharmaceutical industries. Jie has served in Quality, Regulatory Compliance, Change Management and Submission Management & Planning. Jie has deep experience on global regulatory process optimization and project management for both Pharma and Consumer Health products.
Qian has been working through various Regulatory Affairs departments in different global pharmaceutical companies for over 13 years. Qian has wide knowledge on global regulatory regulations and rich experience on international registrations, including submission, strategy, compliance, etc. for worldwide countries.
Nikki has worked in Global Regulatory Affairs in pharmaceutical industry more than 13 years. She is very practiced to global regulatory approvals and registrations through the whole product lifecycle to help clients on planning and strategy to achieve both global and local product launches.
Lich accomplishes Global Submission Management & Planning missions with over 16 years of extensive experience supporting and advising all types of submissions (eCTD, NeeS, ICTD and etc.) worldwide. Lich has abundant experience on global project management on Regulatory Strategy, Operation and Process Outsourcing.
Sophia has worked in global pharmaceutical industries more than 14 years. Sophia has deep experience in multi-functions of Global Regulatory Affairs, especially in Regulatory Compliance Management and Submission Management & Planning. Sophia is an eCTD global expert in industries. Through the trade association, she leverages her knowledge and experience to contribute to China eCTD establishment and implementation.