モレキュラーデバイスジャパン List of News Articles

In recent years, with the emergence of new drugs that have advanced mechanisms of action, particularly biopharmaceuticals, we are facing more sophisticated challenges in the early stages of drug discovery, such as proof of drug concept and high-content screening. For example, in drug concept proof, there is a demand for the visualization of a seamless drug delivery system from tissue sections to the cellular level, as well as intracellular DDS evaluation of biopharmaceuticals at the organelle level. Additionally, in high-content screening, there is a growing focus on using organoids, which are closer to the in vivo environment than traditional flat cultures, requiring highly accurate high-content analysis. Therefore, in this webinar, Leica and Molecular Devices will present the latest imaging solutions to address these challenges. Date and Time: September 22, 2022 (Thursday) 10:00-10:45, 14:00-14:45 (same content for both sessions) Participation Fee: Free Format: Online only (Capacity: 200 participants) Application Deadline: September 21, 2022 (Wednesday)

Basic Knowledge of CSV, Roles of Users and Suppliers, Category Classification, Recent Developments in DI Guidance, Points to Consider in Contracted Operations, Considerations for Managing and Handling Electronic Data, Key Points for CSV and DI Inspections by Regulatory Authorities, Special Seminar with Clear Explanations Based on Extensive Experience!! ◆Instructor Kenichi Ogiwara, Representative of C-Cast Co., Ltd. Currently active after working at Yokogawa Electric Corporation and Nomura Research Institute. ◆Target Audience Individuals involved in CSV and Data Integrity at pharmaceutical companies, medical device manufacturers, suppliers, etc. ◆Prerequisites No specific prior knowledge required. ◆Knowledge to be Acquired 1) Basic knowledge of CSV 2) Role division between users and suppliers in CSV 3) Correct thinking about category classification 4) Recent status of data integrity guidance 5) Japanese authorities' perspective on data integrity 6) Points to consider in contracted operations (labs and manufacturing) 7) Considerations for managing and handling electronic data 8) Key points for inspections of CSV and data integrity by regulatory authorities.