Navigating the regulatory environment and overcoming common difficulties
The number of clinical trials in China that were conducted over recent years has increased, particularly for Japanese pharmaceutical companies. With a growing aging population, an estimated 2.2 billion hospital visits per year, an expansive network of qualified hospitals and research sites, and a skilled talent pool of clinical trial project leaders, China is an appealing location. The Chinese government is also supportive of international partnerships and has introduced an improved regulatory environment for more efficient and accelerated research and new drug approvals.
In this webinar, the featured speaker will discuss the landscape of clinical trials in China, including ways that sponsors can address and ease common difficulties in managing a study in China.
Attendees will learn:
- The impact of recent regulatory reforms, including the Human Genetic Resources Administration of China (HGRAC) regulation
- Best practices for operational oversight and governance
- Practical tips and solutions for developing an effective communications plan
- How to address escalations
Speaker
Qing Liu, MPH, MBA, Director, Project Management, ICON
Qing has been with ICON since August of 2016 and now is the head of ICON China project management team. Qing holds two master’s degrees of MPH from Peking University and MBA from Asia Metropolitan University. She has 15 years clinical research experience including global phase I/II/III/IV clinical trials experience and has dedicated generic and oncology drug development experience (APAC and US).
Qing worked in pharma (Novartis, Sihuan Pharma group) and CROs (PPD, Incrom) prior to joining ICON.
Who Should Attend?
This program is intended for pharmaceutical and biotech professionals involved in:
- Outsourcing Procurement
- Project Management
- Medical Affairs
- Regulatory Affairs
- Clinical Development
What You Will Learn
Webinar attendees will learn:
- The impact of recent regulatory reforms, including the Human Genetic Resources Administration of China (HGRAC) regulation
- Best practices for operational oversight and governance
- Practical tips and solutions for developing an effective communications plan
- How to address escalations
Xtalks Partner
ICON
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON will operate from 150 locations in 47 countries and have approximately 38,000 employees as of July 1, 2021.
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