Driving Innovation: Planning for CTD Submissions with Language Excellence

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Driving Innovation: Planning for CTD Submissions with Language Excellence

This is an On-demand recording from October 2020. 

Leveraging Dr. Victoria Elegant's extensive background in regulatory compliance and approvals for the APAC region, this webinar will discuss how language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China, as well as best practices for CTD project management to ensure precision and regulatory compliance.


The APAC region is home to countries with large patient populations with urgent unmet medical needs. To speed up the approval process for drugs from foreign multinational companies to address urgent unmet medical needs, APAC countries such as China have introduced fast-track review and approval programs through the Drug Administration Law. However, to take advantage of these new fast-track review and approval programs, multinational companies must submit CTDs in Simplified Mandarin Chinese to the NMPA.  With fast turnaround times, highly technical and accurate language, and large project scales, CTD submissions in APAC markets are complex. Language service providers have the scalability to not only handle the massive scale and quick turnaround time, but also to help pharmaceutical companies with project planning for successful CTD submissions in APAC markets.

Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.


Learning Objectives:

·        Understand recent regulatory reforms and innovations in APAC countries such as China.

·        Gain insight into the opportunities and challenges involved in entering the China market and gaining NMPA approval.

·        Leverage technology and best practices to streamline the CTD submission process and project planning process to drive regulatory compliance in CTD translation.

·        Analyze the importance of quality translation in winning NMPA approval through case studies.


Who Should Attend:

·        Regulatory Affairs Professionals

·        Clinical Trial Professionals

·        CMC Professionals

·        Medical/Regulatory Writers

·        Project Managers



·        Professor Victoria Elegant, Head Scientific Advisor, CSOFT Health Sciences

Professor Elegant is a physician who joined the pharmaceutical industry after postgraduate training in obstetrics and gynecology in the UK. She has held positions in global drug development, medical affairs, regulatory affairs, and drug safety in Japan, Australia, Europe and Asia Pacific. She has worked for Amgen since October 2016 and is Vice-President, JAPAC Regional Medical Head, based in Hong Kong. Prior to Amgen, Dr. Elegant was the Vice-President, Regulatory and Medical Affairs, APAC, based in Shanghai for Baxter, and Vice President, Medical Affairs, Asia/ANZ for Baxalta. Professor Elegant is a Fellow of the Faculty of Pharmaceutical Medicine, a member of the FPM International Committee, and is currently working on training programs in the Asia-Pacific region. She is a founding member of the China Medical Affairs Network. She is on the board of the Medical Affairs Professional Society, and is Adjunct Professor, Faculty of Medicine, UNSW, Sydney Australia.

·        Diego Di Leva, Vice President Global Operations & Strategic Partnership, CSOFT Health Sciences

Diego Di Leva is the VP of Global Language Resources for CSOFT, where he leads teams responsible for executing end-to-end project management and supply chain strategy. Originally from Italy, Diego joined CSOFT as an Italian QA Specialist/Translator. After five years in the role, his responsibilities have expanded to cover more managerial and operational roles. Prior to joining CSOFT, Diego worked as a Tech Consultant for two years at a leading global mobile company.

·        Di Lv, Chief Life Science Practice Lead & Executive Director, CSOFT Health Sciences

Di Lv has worked in the international healthcare market for the past 8 years. Di received her first law degree in China and then pursued further studies in the UK, obtaining a second law degree with a focus in human rights. She entered the healthcare market in 2010 with a thorough understanding of China’s healthcare and regulations, initially working for Di first BGI (Beijing Genomics Institute), one of the largest biotechnology firms in China. In the role of Business Development Manager for BGI, Di has traveled to Belgium and Germany to liaise with clinical institutions, medical schools, and pharmaceutical companies.

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