The pharmaceutical industry is aware that the International Council for Harmonisation is planning to merge the guidelines for Good Clinical Practice (E6) and General Considerations for Clinical Trials (E8). To prepare for this change in 2022 it behoves all clinical trial professions to ensure they are working to the latest expectations when managing their clinical programmes.
Meet the expert trainer Tom Lenahan. He has experience in all aspects of STO events and hands on examples from all perspectives – operator and contractor sides.
This interactive course is recommended for those who have experience in clinical trials & patient engagement and wish to develop their skills on how PRO measurement is best implemented & sustained to advance patient care.
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This unique course provides a practical & in-depth understanding of HTA decision making across EU markets and will focus on the evidence generation underpinning a convincing value proposition to different HTAs.
This course will provide critical insights into various types of IVIVC and practical exercises focused on absorption determination, time scaling, prediction, determination of dissolution limits, case resolution problem from design of studies to utilization of IVIVC.
This unique course provides a practical & indepth understanding of the electronic systems and technologies used in clinical trials, and brings clarifications on global regulation, requirements, compliance & quality concerns.
Technical Safety Management – an intensive 3-day course on PHA, HAZOP, LOPA, Functional Safety, SIS & SIL, Risk Management & Control of Operational Hazards led by expert trainer Dr. Tijs Koerts.
This 3-day master-class seminar will provide a comprehensive, in-depth introduction to the discipline of well integrity, and discuss in detail how we can achieve it effectively and efficiently during the design and operational phases, as well as after wells are abandoned.
Understand the specific regulatory & legal environment concerning generic medicinal products. Update your knowledge on regulatory procedures for new applications and variations. Get an overview of the documentation for Generic applications. Understand the current integrated life-cycle approach from development to registration and maintenance, including ICH Q12.