PharmiWeb.com - Global Pharma News & Resources

Training - Events

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…
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…

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…

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
20-Oct-2020 - 21-Oct-2020

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

The Course In this highly practical course we look at the root cause of typical inspection findings and work with delegates to develop personal corrective and preventative action plans. 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 delegate…
J33 Advanced Monitoring

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

The Course The MHRA GCP Inspectorate has updated their definition of critical to include, ‘where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations.’ This follows numerous issues with inspector access to TMFs and incomplete TMFs. The TMF provides the basis for inspection by the competent authority (2005/28/EC). The UK Clinical Trial Regulations (2004/1031, Regulation 31A) require that the sponsor must keep a TMF and it must be readily available and shall at all times contain the essential documents relating…
J32 Essentials of Essential Document Management; Managing the TMF

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

The Course An Introduction to Clinical Trials and Clinical Trial Practice, the ICR’s flagship training course, is accredited by Cranfield University. This highly practical course explores the relevance of clinical research in drug development and summarises the ethical and regulatory requirements for clinical trials. It covers clinical trial methodology and summarises the principles of Good Clinical Practice. The course gives an overview of the various aspects of clinical research and will be of interest to all members of the clinical study team. It uses a combination of lectures, tutorials and group workshops. Delegates receive a comprehensive workbook and a copy of ICH GCP guidelines. The content of the course will equip delegates to sit the ICR Certificate examination. Learning Objectiv…
J31 Introduction to Clinical Trials and Clinical Trials Practice

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

The Course In this one day course we explore clinical investigations for medical devices.  We will review the latest legislation and its impact on determining whether a clinical trial is required.  Our experienced trainer will guide you through the key stages in designing and executing your clinical investigation.  Through practical exercises delegates will tackle common challenges and develop strategies to overcome them. Learning Objectives • Understand how to determine whether or not a clinical investigation is required • Describe the key points of the MDR and their impact on clinical investigations • Discuss common challenges in project managing and monitoring clinical investigations and how to overcome them Course Outline • Overview of MD classifications EU and US …
J30 Clinical Investigations for Medical Devices (Foundation)

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

The Course Vendor Oversight is currently a hot topic as sponsors and vendors aim to get to grips with what is really required.  You don’t want to outsource and then expend multiple resources to manage and oversee your trial.  As a vendor you want to get on with the outsourced clinical trial in the most effective way feasible without micromanagement from your sponsor company.   What is required to compliantly and efficiently implement vendor oversight? What are the risks and challenges of not getting this right from the beginning? This course will aim to work through some of these challenging topics with time given to work through specific scenarios from the attendees.  Learning Objectives • Understand  the regulatory expectations that impact Vendor management and V…

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

The Course ICH E6 (R2) has emphasized the importance of risk management in relation to ensuring subject safety and rights as well as data integrity in clinical trials. Understanding, oversight and improving clinical trial processes, is a fundamental way of managing these risks. this course demonstrates ways to map processes, how to measure them and to understand how they might fail. It provides a tool kit for root cause analysis and provides approaches to improve processes so as to minimize risk. Throughout, examples are used from clinical trials and participants are encouraged to practise the skills they learn.  Learning Objectives By the end of this course, you will be able to... Understand the relevance of process thinking in clinical trials Learn how to map processes Learn how…
J29 Process Thinking in Clinical Trials

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

The Course Are you working with clinical researchers but not actually engaged in clinical research yourself?  Do you find yourself struggling to understand the myriad of acronyms that people use? Do you wonder why your colleagues seem to obsess over documentation and get stressed over "Self Addressed Envelopes" [SAEs]? Then join us for this double espresso style course. We'll bring the coffee! Learning Objectives • Define clinical research • Understand key clinical research terms • Identify the key stakeholders in a typical project team • Summarise the responsibilities of key positions • Explain Serious Adverse Event Reporting • Recognise documents that may need to be kept in the Trial Master File Course Outline • What is clinical research? • Demystifying the Alphabet Soup • Over…
J28 Clinical Research for Non-Clinical Researchers
03-Sep-2020 - 03-Sep-2020

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

The Course This course enables delegates to develop an effective strategy to plan and prepare efficiently for an audit/inspection through understanding the process and procedures.  Delegates will learn to recognise and prioritise methodologies to enable them to prepare for a successful audit/inspection and identify key stakeholders in the process. The course will explore how to reduce the anxiety of audits/inspections by having an effective strategy to be ‘audit ready’.   Learning Objectives • Outline the process and procedures of an audit/inspection • Appreciate the process from the auditors perspective • Recognize and prioritize methodologies to prepare for an audit/inspection • Identify key stakeholders in the audit/inspection process • Plan and prepare efficiently for an a…
J27 Inspection Readiness

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…
J24 Essentials of Clinical Trial Monitoring

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

The Course This course explores the role of the manager in the clinical trials environment and defines the skills and competencies required. It provides the opportunity to review and identify individual strengths, develop areas for improvement and provides an understanding of the role of the manager as mentor and motivator in order to create a high performance team. It will relate effective time management to the achievement of key business objectives, tasks and timelines. It discusses being assertive whilst having the ability to negotiate and their role in reducing the risk of conflict in the workplace, and other strategies for dealing with difficult people and situations. The course involves trainer input, exercises, problem solving and discussion to create an interactive and stimulating…
J25 Skills and Competencies of a Clinical Trial Monitor

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

The Course The course will give an overview of clinical pharmacology, define phase 1 studies and describe how they fit into the clinical development programme. Delegates will be guided through the regulatory and clinical aspects of phase 1 studies and identify the key safety and ethical issues that need to be managed. The issues relating to design, set-up, choosing subjects and conduct of phase 1 studies will be discussed. The course will use trainer input, exercises, and delegate interaction. Learning Objectives • Give an overview of Clinical Pharmacology.  • Define Phase 1 studies and describe how they fit into the clinical development programme.  • The delegates will be guided through the regulatory and clinical aspects of Phase 1 studies and identify the key safety and ethica…
J23 Introduction to Pharmacology and Phase 1 Clinical Trials
18-Jun-2020 - 18-Jun-2020

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

The Course This course is an introduction to the knowledge, skills and competencies that a line manager requires for performance management in the clinical research environment.  It aims to increase participants’ understanding of the manager’s role and provides an opportunity to review and identify individual strengths and develop areas for improvement.   This practical course has trainer input, group exercises and delegate interaction.    Learning Objectives   • Define the role of a manager  • Distinguish between line management and functional management • Summarise the major aspects of managing line teams, project teams and individuals  • Analyse your own individual management style and adapt it for different situations  • Identify the tools and te…
J22 Introduction to Line Management

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

Course Details Are you a clinical researcher who has to review and approve data management plans, but find yourself struggling to know what you should be looking for?  Do you have to select a Data Management vendor but don’t know how to evaluate their capabilities?  In this course we will explore data management terminology, data management plans, coding and (e)CRFs so that you can work more effectively with data management specialists. Learning Objectives   • Understand clinical data management terminology • Have a good understanding of data management plans, coding and design of (e)CRFs • Communicate effectively with data management specialists within a clinical project team Course Outline   Data Management basics • Objectives of data management • Regulatory backgrou…
J21 Data Management for Clinical Researchers