Pharmaceutical, biotechnology and medical device companies and clinical researchers need to assure regulatory authorities of the reliability of the data that they generate during product development and testing – that is, to demonstrate data integrity. Practices that provide assurance of data integrity in clinical research are required by law and/or established as expectations in regulatory guidance. The data are reviewed in regulatory applications or during regulatory inspections of clinical trial sponsor and investigational sites. Inadequacies of data integrity are frequently reported by inspectors and result in regulatory actions against the organizations or individuals concerned. This course explains the requirements and describes principles and practices that should be followed by trial sponsors, investigators and other clinical research personnel to assure regulators of data integrity.
Pharmaceutical and biotechnology companies and researchers need to assure regulatory authorities of the reliability of the data that they generate or acquire during product development and manufacturing – that is, to demonstrate data integrity. Data integrity is assessed during regulatory inspections of manufacturing and research sites. Inadequacies of data integrity are frequently reported by inspectors and result in regulatory actions against the companies or individuals concerned. Practices that assure data integrity are required by law and/or expected by regulators in the fields of nonclinical and clinical research, manufacturing and distribution, and pharmacovigilance of medicinal products. This course explains the requirements and describes principles and practices that should be followed to assure regulators and contractual partners of data integrity in the manufacture of medicinal products.
This module provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.
This course describes the requirements that must be met by, and options available to, the sponsor during the conduct of an authorised clinical trial. It identifies the various interactions with MSCs that occur via the Clinical Trials Information System (CTIS), and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT11 sets out the European legal and regulatory context for clinical trials and describes how to apply via the CTIS for authorisation to conduct trials. The two courses therefore provide an ideal foundation for understanding and complying with the new law.
This course aims to provide a comprehensive understanding of how consumer behavior can influence customer experience and strategies for enhancing and building customer experience in B2B contexts, including customer segmentation, targeting, and positioning, as well as measuring customer experience gap and defining customer expectations. After the successful completion of the course, you will be able to learn about the following, How to build customer experience and how consumer behaviour can influence this experience. Strategies to influence and enhance customer experience. Enhancing customer experience in B to B context. Strategies to built customer relationship. Building customer experience with segmentation, targeting and positioning. Measuring customer experience gap. Defining customer expectations. This course aims to provide strategies and techniques for building and enhancing customer experience, while understanding the influence of consumer behavior on this experience, as well as the importance of customer relationship management in B2B contexts, and the role of segmentation, targeting, and positioning in building customer experience. The course also covers techniques for measuring and defining customer expectations, and strategies for closing the customer experience gap. This course aims to provide a comprehensive understanding of how to build and enhance customer experience, including the role of consumer behavior, and strategies to build and maintain customer relationships. Additionally, the course covers the importance of segmentation, targeting, and positioning in creating a positive customer experience and ways to measure and meet customer expectations. VIDEO - Course Structure and Assessment Guidelines Watch this video to gain further insight. Navigating the MSBM Study Portal Watch this video to gain further insight. Interacting with Lectures/Learning Components Watch this video to gain further insight. Managing Customer Experience Self-paced pre-recorded learning content on this topic. Managing Customer Experience Put your knowledge to the test with this quiz. Read each question carefully and choose the response that you feel is correct. All MSBM courses are accredited by the relevant partners and awarding bodies. Please refer to MSBM accreditation in about us for more details. There are no strict entry requirements for this course. Work experience will be an added advantage to understanding the content of the course. The certificate is designed to enhance the learner's knowledge in the field. This certificate is for everyone who is eager to know more and get updated on current ideas in their respective field. We recommend this certificate for the following audience. Customer Happiness Coordinator Client Care Specialist Experience Enhancement Agent Satisfaction Strategist Service Excellence Ambassador Feedback Facilitator Interaction Improvement Manager Client Delight Director Customer Journey Navigator Support Satisfaction Supervisor Average Completion Time 2 Weeks Accreditation 3 CPD Hours Level Advanced Start Time Anytime 100% Online Study online with ease. Unlimited Access 24/7 unlimited access with pre-recorded lectures. Low Fees Our fees are low and easy to pay online.
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