Clinical Trial Supply will cover various supply challenges coming up through clinical trial phases including manufacturing, packaging & labelling, planning drug supply and temperature maintenance.
As East Asia is becoming the hub of biosimilar products, one of the most required topics is Cell & Gene therapy trials and how to maintain temperature in logistics. In Pinpointing difficulties in transportation of Cell & Gene therapy products, We will be discussing about main challenges for cell therapy products throughout clinical trial stages from manufacturing, logistics and storing. In case you are using vendors for this, we will be talking about what ability you should check and how to manage supply crisis with your partner smoothly.
Another main point of clinical trials is preparing cGMP inspection as many companies in this region are aiming to be marketed in US, Europe at the same time. With the extended drug safety regulations towards global standard, we need to be aware of QbD which requires product and process understanding and process control, based on sound science and quality risk management. For successful GMP inspections and be compliant with global standard, Key Factors of success in preparing cGMP inspection according to Quality by Design development sessionwill provide you a basic knowledge and great case study.
With close partner relationship between sponsors and specialised vendors in this Asian market, how to balance outsouring for your study is very important. Especially planning your supply chain process and assessing supply cost accurately is one of the key points sponsors should be familiar with to save study costs. Even though you are not directly involved in all supply technologies, you need to be in charge of arranging vendors and planning logistics for the trials. In Establishing forecasting best practice: minimizing cost associated with your supply chain through waste minimization session, you will have insights on how to assess supply cost accurately for global trials and what technologies are out there for forecasting methods to ensure timely operations.
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