Where China's Top Industry-Focused Clinical Development Leaders Meet
Now in its 9th year, CHINATRIALS is the longest-running annual gathering of 350 top senior clinical development executives who are responsible for their company’s clinical development activities in China. Each year we discuss the biggest challenges and opportunities facing China's development industry and explore and share the best strategies to meet these challenges head-on. Topics and key discussion takeaways are specifically tuned for this senior audience to provide practical, business-oriented information that can be immediately applied to their daily business focus and responsibilities.
For 2016, we have tuned the event to focus more on the rise of Chinese domestic pharma and biotech and are expecting a record number of attendance from the domestic side!
Key Features for 2016!
1. "China Clinical Pipelines Innovation & Strategy Showcase"
In this exciting new showcase, Chief Medical Officers/Heads of Clinical Development from 20 of the most exciting domestic biopharma companies (whose pipeline innovation are created within China or focused on the China market) will give a short introduction of their most exciting preclinical/clinical pipeline projects. After the short introductions, our expert speakers will take part in exciting panel discussions addressing their company’s unique innovation strategies.
Click here to see the latest list of innovation companies and presenters!
2. In-Depth Session on Immuno-Oncology: Latest Clinical Research & Medical Practice Advancements and Their Impact for China Development
- Overview of latest key data from leading drugs currently in development
- What is the impact for how China's devleopment should respond?
- What are the key lessons learned to date on safety and biomarker strategy?
- Clinical and regulatory considerations
- With so many similar IO-based drugs now in development, how should the industry collaborate moving forward?
3. Workshop on the Impact of Bioequivalence Studies & Consistency Evaluation for Generics in China
The new policy requiring generic drugs in China to demonstrate bioequivalence and consistency to branded medicines is on the minds of a lot of development experts in China. This special pre-conference workshop will provide the latest updates in this hot area and cover:
- Overview of the new CFDA policy on BE study requirements
- Pharmaceutical CMC/formulation aspects
- Challenges conducting clinical trials for BE
- Study design, data management and statistics challenges
4. “How Do Chinese Companies Go Global?”: Parallel Development of New Drugs in China and US
As Chinese R&D companies continue their rise, their global ambitions are also growing. This session will provide a detailed look on how Chinese companies may begin to explore and plan the process to do simulanteous drug development in China, US and other countries and include hot topics such as:
- Gap analysis of China CTA package for US IND submission
- Management of US studies with US-China combined teams
- Preparation of NDA submission for China-made new drugs
5. Practical & Action-Oriented Sessions on Site Inspection & Quality Management
Site inspection and quality management are two of the most important and challenging topics facing the China clinical development industry this year. In-depth sessions will include case studies of recent inspections and their impact, providing attendees with clear and practical takeaways that they can learn from and immediately apply to their daily job responsibilities.
6. Principal Investigators’ Forum On Improving Collaboration & Engagement Between Industry and Sites
This session will feature at least 3 of China’s top principal investigators in a rare gathering where our expert moderators will conduct candid, interview-style discussion to draw insights into the PI's thought process and help determine how industry and sites can improve communication and collaboration. There will be plenty of time set aside for audience Q&A with the investigators as well!