94-99, Citadines Holborn-Covent Garden London (Apart Hotel London), High Holborn, London, Greater London, WC1V 6LF, United KingdomA 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.
41, Münchensteinerstrasse, Basel, 4052, SwitzerlandThis one-day workshop will provide an understanding of the key aspects of Pharmacovigilance (PV). It will provide an overview and introduction to the definitions such as sources of cases, MedDRA (Medical Dictionary for Regulatory Activities) coding, case processing, and a first glance at a PV database.
Cedar Court, White Waltham, Maidenhead, Berkshire, SL6 3LW, EnglandCourse 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…
41, Münchensteinerstrasse , Basel, 4052, SwitzerlandIt is essential to apply efficient and accurate strategies for monitoring outsourced clinical trials. This one-day course is designed for anyone involved in or those seeking a better understanding of vendor management and vendor oversight. The key topics addressed are: ● What is vendor management and what is vendor oversight ● The many aspects of vendor oversight ● What is governance and how to implement an effective government structure ● Risk management when outsourcing ● Maintaining healthy business relationships to support effective management and oversight ● Regulatory inspections when outsourcing