Broadcast #2 is identical for this recording.
Widespread and diverse, the Asia-Pacific (APAC) region spans over two dozen countries where a population of over two billion and growing conduct business in more than a dozen major languages including Mandarin Chinese, English, French, Dutch, Korean, Japanese, Filipino, Vietnamese, Thai, Malay, and Khmer. Unlike Europe where clinical trial regulations are largely standardized between the European member states, no such organization or harmonization exists in the APAC region. Therefore conducting multi-country studies within the region becomes much more complex for clinical sponsors to source comparators and manage the packaging and distribution of clinical supplies. Separate from regulatory hurdles, practical considerations including infrastructure availability and quality, language barriers, cultural business norms and local product availability can and do vary widely within the region and add a further level of complexity for sponsors.
Directing clinical supply for use in the region from a single location, whether located in or outside of the APAC region can be inefficient from both a cost and time standpoint. However, using a regional networked-based approach, study sponsors can create a clinical supply packaging and distribution engine within the APAC region that is well positioned to perform more effectively, efficiently and with less risk of supply chain disruption than what would be possible from a single source.
In this webinar, our featured speaker will explore how to leverage the major clinical supply centers of China, Singapore and Japan to support clinical trials within the Asia-Pacific region for both local and global study sponsors. We will explore clinical packaging, logistics and import/export considerations that should be taken into account when developing a clinical supply strategy, and why there is no substitute for on-the ground local expertise.
- Current trends and challenges within the APAC region
- The regional regulatory environment
- Why a single-location supply strategy may not be optimal
- How best to leverage each of the major APAC clinical supply centers
- The importance of having local knowledge and expertise
Daniel Gao, Site Director, Clinical Supply Services – Shanghai
Daniel Gao is Site Director of Catalent Pharma Solutions’ Shanghai, China clinical supply facility. In this role, he oversees clinical supply operations in China with an emphasis on service delivery, quality and operational excellence. Previous roles at Catalent include Account Director of Greater China where he focused on supporting customers and business development within China. Prior to joining Catalent, Daniel was the Head of Clinical Trials, China for Cardinal Health. He holds an MBA from Ryerson University, Canada with a specialization in Supply Chain Management and an MSc. in Project Management from Manchester University, UK.
Who Should Attend?
Senior professionals from Pharmaceutical, Biotechnology and Medical Device manufacturers involved in:
- Clinical supply chain / distribution / procurement
- Clinical packaging / labeling
- Clinical operations
- Quality assurance
- Regulatory affairs
A global leader in Clinical Supply, Catalent partners with sponsors to accelerate and scale their trials with innovative, flexible and reliable supply solutions. Catalent provides comprehensive and integrated services for sponsors and studies of all sizes. We offer full-service packaging, cold chain distribution and specialized capabilities across the globe to solve clinical supply challenges.