The landscape of clinical trials in Asia is changing. Many global pharmaceutical companies may have first decided to move to Asia for the patient pool and cheaper cost. But, the spotlight on Asia is now on R&D in the pharmaceutical sector rather than just the clinical trials industry. Companies need to set their strategic sights on a future world where Asia is not just a market for the pharma industry, but could make a key contribution to drug discoveries and development as well.
OCT will be covering Developing methodologies for RBM(Risk Based Monitoring) and oversight, as itis becoming de facto in pharmaceutical industry and many countries including Korea. Many people say RBM will improve clinical trial efficiency and oversight manner, however, we still have concerns on workloads and how to apply it on our won trials. In this session, you will get case study on building your own monitoring plan and what would be the benefits and pitfalls for using Risk Base Monitoring in Korean trials.
Another biggest change in clinical trial is industry 4.0, which is affecting every industry. AI is being used in clinical development stage as well as clinical trials itself to find right compounds with less failure. Especially cell therapy & gene therapy products are more personalised therapy and key industry in East Asia region, it can be beneficial if you could raise success rate and save time in development stage. With Exploring effectiveness on AI in new drug development in changing paradigm to Personalised Medicine session, you will see how AI can contribute in your R&D part reducing time and risk of failure with Ms Yang’s experience on real case studies on partnering with pharmas.
Lastly, with arising interests in conducting clinical trials in Asia, many chose changing regulatory requirements with few explanation in foreign languages as a first hurdle for non-native players. CRO and partners have been always keys to the non-local sponsors to get clinical trials done in compliance with local regulations on time as well as cultural differences in work environment. In CRO selection and Management — Under the new era of Regulatory revolution in China session, you will learn about how much Chinese regulations got closer towards ICH guidelines and what would be the major cultural factors you have to consider when you are conducting trials in China.
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