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94-99, Citadines Holborn-Covent Garden London (Apart Hotel London), High Holborn, London, Greater London, WC1V 6LF, United Kingdom

A clinical Research Associate (CRA) primarily manages the managerial aspects of a number of clinical trials, at every stage of the process. Accredited classroom based training - Duration 3 days. The role of the CRA will be covered in intensive detail with visual aids and hands-on training provided by experienced industry professionals. This is fundamentally “practical” and “hands on” workshop that focuses on current practice to ensure the CRA delegate develops practical experience of the role. Participants will learn about the role and responsibilities of the clinical research associate in the context of the regulations and rules that govern clinical trials.
CLINICAL RESEARCH ASSOCIATE (CRA) - (BEGINNERS)

41, Münchensteinerstarsse, Basel, Basel-Stadt, 4052, Switzerland

This training workshop will take place in a virtual format via a digital platform with live trainer interaction and interactive activities which will enable you to ask questions and discuss theory to ensure you have a comprehensive understanding of the course content. A four half-day modules course for Newcomers to the industry, clinical research personnel with up to 2 years experience, those returning to “the sharp edge” of Clinical Operations, scientists working in related areas, offering an overview of the drug development process including the following topics: ● Good Clinical Practice / ICH Guidelines / Directives● “Who’s Who” in Clinical Research – Roles and Responsibilities● Conducting Clinical Trials: pre-, during and post study activities● Clinical Trial Methodology and Design● Un…
Virtual Classroom: From Molecule to Medicine

Cedar Court, White Waltham, Maidenhead, Berkshire, SL6 3LW,

The Course Clinical Trial Administrators are at the heart of any project team and play an essential role in the clinical trial process. This course gives an in-depth look into some of the aspects of clinical trials. It aims to give an understanding of the history and evolution of clinical research.Delegates will be guided through the essential documents required at each stage of the clinical trial process and their respective functions, an outline of the key roles and functions, and explores how the role of the CTA fits into the clinical trial process.The course also gives further insight into the EU legislation governing trials, ethics committees, audits and inspections, using and creating SOPs, auditing and archiving. The course will utilise trainer input, exercises, and delegate interac…
24-Nov-2020 - 24-Nov-2020

Cedar Court, White Waltham, Maidenhead, Berkshire, SL6 3LW, England

The Course Do you want to work SMARTER not HARDER?  This course is focused on the needs of a clinical researcher and is a very practical course with exercises and methods to build and develop the core soft skills to allow you to work more efficiently and increase your productivity. Oftentimes issues arise due to communication breakdown.  We look at how information should flow within project teams and examine when different types of communication are most effective. We all work to tight deadlines, but do you find yourself wondering where your day has gone?  Our trainer will help you examine your working practices to enable you to set goals, prioritise activities and develop an effective working plan, while keeping your eyes open for those time thieves.   Learning Objec…

Cedar Court, White Waltham, Maidenhead, Berkshire, SL6 3LW, England

The Course This practical course defines the role of the clinical research monitor and explains the interaction with others in key roles as part of the clinical trial process as well as exploring the more complex aspects of clinical trial monitoring. Guidance will be given on best practices for selecting investigators, conducting monitoring visits and safety reporting. Delegates will explore strategies for dealing with common clinical trial management issues and how to adopt a preventative approach to handling monitoring issues. The course uses a blend of trainer input, exercises and delegate interaction. Learning Objectives • Define the roles and responsibilities of Monitors, Sponsors, Investigators and Ethics Committees • Describe the key criteria for selecting investigators • Summarise…

Muenchensteinerstrasse 41, Basel, Basel-Stadt, 4052, Switzerland

This course will be delivered in two half-day modules. It offers a general overview of the drug development process and most relevant tasks and responsibilities within the clinical research setting, focusing on practical aspects. It is designed for those with little or no experience in clinical research or those seeking an overview of the clinical research process, regulations, terminology, acronyms, roles and responsibilities within clinical research.
Virtual Classroom: Introduction to Clinical Research
18-Nov-2020 - 18-Nov-2020

41, Münchensteinerstrasse, Basel, 4052, Switzerland

This one-day course provides a general overview of the clinical research process, regulations, terminology, acronyms as well as roles and responsibilities within the clinical research setting. The following topics will be covered: • Developing a drug in the pharmaceutical industry – from the idea to the product you buy in the pharmacy – and the contributions of clinical research• What is a clinical study – the four phases of clinical development• Who are the key players and what are their roles in the process• The language and abbreviations the clinical research team are using every day• What are the rules, guidelines and laws that need to be followed and why are they so important• How is a clinical study performed – from preparation over conduct to termination of a study• A key to a succe…
Introduction to Clinical Research
17-Nov-2020 - 17-Nov-2020

Cedar Court, White Waltham, Maidenhead, Berkshire, SL6 3LW, England

The Course Statistics is the art and science of summarising data.  Statistics play an essential role in all stages of clinical research from design through to analysis and interpretation.  Clinical Trials generate large volumes of data but most of us are looking for the “punch-line”;  Did the new treatment work?  Were the two groups being compared the same of different?  We rely on statistics to help us design the most appropriate trial to answer our questions, to determine the required sample size and to interpret the results.  A poorly designed study wastes time, resources and puts patients at unnecessary risk.  A solid understanding of statistical principals is important for all team members, not just the team statistician; however for many of us stati…

Muenchensteinerstrasse 41, Basel, Basel-Stadt, 4052, Switzerland

It is becoming increasingly important for non-statisticians to understand the value and application of statistics to maximise the value of data. The course will delivered virtually in two half-day modules and will focus on understanding the basic statistical concepts, interpreting output and discussing how the knowledge can be applied and integrated efficiently. The objective of the course is not to teach how to become a statistician, but to help to work with statisticians, ask them the right questions and get the maximum value when reviewing statistical output. The basics of statistics are presented to give background and a common base to start from and the applications and use of statistics in drug development is then discussed. The role of the statistician and their ability to help with…
Virtual Classroom: Clinical Statistics for Non-Statisticians

Cedar Court, White Waltham, Maidenhead, Berkshire, SL6 3LW, England

The Course This practical course provides delegates with basic project management techniques that can be applied to clinical trial project management. 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. Delegates will receive a comprehensive course workbook. 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 v…
04-Nov-2020 - 04-Nov-2020

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

The demand for public health interventions is growing as the NHS and social care system tries to ensure future sustainability. 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 health to try to reduce demand ac…

Cedar Court, White Waltham, Maidenhead, Berkshire, SL6 3LW, England

The Course Approximately 1.5 million different medical devices are available globally; with thousands of new and innovative medical devices being introduced to the market every year. While there is legislation at the national and regional level ISO 14155 provides a global standard for clinical investigations on human subjects.   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 t…
29-Oct-2020 - 29-Oct-2020

Cedar Court, White Waltham, Maidenhead, Berkshire, SL6 3LW, England

The Course This course provides an in-depth look at the regulatory systems currently in operation in the EU and their impact, together with UK legislation, on the conduct of clinical research. 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. Learning Objectives • Outline recent major developments in Good Clinical Practice • Discuss the purpose and impact of EU regulations on the conduct of clinical re…
J35 GCP for Experts