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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
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.
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
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