10983 Courses delivered On Demand

The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them.

The Centralised Procedure (CP) is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA) on the basis of a single application. In the CP, one successful application leads to a marketing authorisation being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this module we describe the role of in-vivo PK and PD studies in a drug development programme, set out the uses to which the findings can be put, and discuss their implications for clinical development and application for marketing approval.

Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because of their commercial unattractiveness. Development of such products is successfully encouraged through incentives offered by regulatory authorities. To qualify for important incentives, the sponsor of a drug must gain ‘orphan designation’ for its use in an indication. This module describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area.

This module extends the learner’s understanding of pharmacokinetic and pharmacodynamic studies from the basics described in our companion module PKPD01, An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration. It provides detail on a variety of aspects of such studies: design, sampling, data analysis, research in special populations, and bioequivalence testing.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.

This module provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.

This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.

Overview Enrol in our Psychological Wellbeing Practitioner - Level 2 today and build the necessary skills, knowledge and experience to transform your career. The Psychological Wellbeing Practitioner - Level 2 could enhance your continuing professional development thus propelling you more towards your dream job. This Psychological Wellbeing Practitioner - Level 2 could be your key, if you are interested in a long term career in the field of Psychological Wellbeing Practitioner - Level 2. This Psychological Wellbeing Practitioner - Level 2 course consists of a number of easy to digest, in-depth modules which are designed to provide you with detailed knowledge on Psychological Wellbeing Practitioner - Level 2. This Psychological Wellbeing Practitioner - Level 2 aims to accompany you through your journey to help you become a master of Psychological Wellbeing Practitioner - Level 2. Learn through a mixture of interactive lessons and online study materials. How will I get my certificate? You may have to take a quiz or a written test online during or after the course. After successfully completing the course, you will be eligible for the certificate. Who is this course for? There is no experience or previous qualifications required for enrolment on this Psychological Wellbeing Practitioner - Level 2. It is available to all students, of all academic backgrounds. Requirements Our Psychological Wellbeing Practitioner - Level 2 is fully compatible with PC's, Mac's, Laptop, Tablet and Smartphone devices. This course has been designed to be fully compatible on tablets and smartphones so you can access your course on wifi, 3G or 4G. There is no time limit for completing this course, it can be studied in your own time at your own pace. Career path Having these various qualifications will increase the value in your CV and open you up to multiple sectors such as Business & Management , Admin, Accountancy & Finance, Secretarial & PA, Teaching & Mentoring etc. Course Curriculum 1 sections • 8 lectures • 02:02:00 total length •Module-1: Introduction to Psychotherapy: 00:15:00 •Module-2: Skills of a Psychological Wellbeing Practitioner: 00:15:00 •Module-3: Types of Therapies: 00:15:00 •Module-4: Engaging and Assessing the Patients: 00:18:00 •Module-5: Low Intensity CBT Treatment: 00:15:00 •Module-6: Forms of Psychotherapy: 00:16:00 •Module-7: Helping the Client in Crisis: 00:15:00 •Module-8: Crisis Intervention: 00:13:00