PharmiWeb.com - Global Pharma News & Resources

Training - Events

Suite 1, Cedar Court, White Waltham Road, Maidenhead, Berkshire, SL6 3LW, United Kingdom

Learning is through a combination of trainer input, discussion groups and exercises. There will be a workshop where delegates will develop a plan for tracking and managing a clinical trial case study. Learning Objectives Define basic project management terms Create a work breakdown structure and task network Develop a skills matrix Define a project schedule and conduct critical path analysis Analyse resource requirements Describe and apply a process for managing risks List the common parameters that need managing and tracking Outline a general process for dealing with variance Outline techniques for modifying the project plan Develop strategies for managing change Define strategies for managing and maintaining an effective project team

University of York, York, York, YO10 5DD, United Kingdom

As the demand for health and care services grows and finances become more constrained, there is an increasing need for economic evaluation in the public sector. NHS, social care and public health organisations are expected to be able to economically justify any changes in care pathways they propose and there are concerns not only around cost-effectiveness but also the affordability of new initiatives. Many public sector bodies are under pressure to achieve efficiency and productivity savings in order to balance budgets. They are seeking innovations that will reduce cost pressures and they need to understand the impact of changes in different sectors, including primary, community and social care as well as acute care. There is a focus on primary and secondary prevention approaches in public…

York, York, YO10 5DD, United Kingdom

As the demand for health and care services grows and finances become more constrained, there is an increasing need for economic evaluation in the public sector. NHS, social care and public health organisations are expected to be able to economically justify any changes in care pathways they propose and there are concerns not only around cost-effectiveness but also the affordability of new initiatives. Many public sector bodies are under pressure to achieve efficiency and productivity savings in order to balance budgets. They are seeking innovations that will reduce cost pressures and they need to understand the impact of changes in different sectors, including primary, community and social care as well as acute care. There is a focus on primary and secondary prevention approaches in publi…

Suite 1, Cedar Court, White Waltham Road, Maidenhead, Berkshire, SL6 3LW, United Kingdom

In this course we explore ISO-14155 in detail.  ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.  This International Standard specifies general requirements intended to: Protect the rights, safety and well-being of human subjects Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results Define the responsibilities of the sponsor and principal investigator Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
30-Oct-2019 - 30-Oct-2019

Suite 1, Cedar Court, White Waltham Road, Maidenhead, Berkshire, SL6 3LW, United Kingdom

Starting with a refresher on the history of medicinal product regulations and the need for ethics, the course explains in more detail the practical applications of GCP and outlines recent major developments in GCP. It also explores the impact of EU data protection laws on clinical research and summarises other current issues that affect clinical trials. Delegates will receive a complimentary copy of the ICH GCP guidelines and a workbook.
24-Oct-2019 - 24-Oct-2019

41, Münchensteinerstrasse, Basel, Basel-Stadt, 4052, Switzerland

This course offers a thorough update of the current understanding and interpretation of Good Clinical Practice and practical guidance/advice on how to ensure readiness for Health Authority inspections, both of Sponsor and Investigator sites.
ICH GCP Refresher
23-Oct-2019 - 24-Oct-2019

Suite 1, Cedar Court, White Waltham Road, Maidenhead, Berkshire, SL6 3LW, United Kingdom

Through case studies, we will address challenging monitoring situations and develop strategies for investigator selection, fraud detection, improving patient recruitment and for motivating investigator sites. Delegates will explore how both technology and legislation will impact the role of the monitor.   We also discuss key principles in project planning and execution to allow experienced CRAs to begin to develop the skills required for a Lead CRA or Clinical Trial Manager role. Delegates will learn how to apply project planning principles to monitoring to improve efficiency.   It is recommended that delegates have a minimum of two years of monitoring experience.