10669 Professional Development courses in Wrexham delivered On Demand

This is a basic course on keeping yourself updated about D&I concept, its evolution and history, worlds stats, benefits , best practices and countries we shall be learning from. The objective is to Promote diversity and inclusion in workplace and actively create a productive work environment within a team that is free of harassment and bullying. Recognised Accreditation This course is accredited by continuing professional development (CPD). CPD UK is globally recognised by employers, professional organisations, and academic institutions, thus a certificate from CPD Certification Service creates value towards your professional goal and achievement. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. What is CPD? Employers, professional organisations, and academic institutions all recognise CPD, therefore a credential from CPD Certification Service adds value to your professional goals and achievements. Benefits of CPD Improve your employment prospects Boost your job satisfaction Promotes career advancement Enhances your CV Provides you with a competitive edge in the job market Demonstrate your dedication Showcases your professional capabilities What is IPHM? The IPHM is an Accreditation Board that provides Training Providers with international and global accreditation. The Practitioners of Holistic Medicine (IPHM) accreditation is a guarantee of quality and skill. Benefits of IPHM It will help you establish a positive reputation in your chosen field You can join a network and community of successful therapists that are dedicated to providing excellent care to their client You can flaunt this accreditation in your CV It is a worldwide recognised accreditation What is Quality Licence Scheme? This course is endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Benefits of Quality License Scheme Certificate is valuable Provides a competitive edge in your career It will make your CV stand out Course Curriculum Introduction Definition & History 00:05:00 Importance of D&I and Reason of Importance 00:04:00 Type of D&I Type of D&I 00:04:00 Policy and Framework for D&I Policy and Framework for D&I 00:05:00 7 Best practices for changing your work culture 7 Best Practices for Changing Your Work Culture 00:06:00 Importance of D&I for good governance Importance of D&I for Good Governance 00:03:00 World statistics on D&I and countries with best D&I practices World Statistics on D&I and Countries with Best D&I Practices 00:09:00 Summary 00:02:00 Obtain Your Certificate Order Your Certificate of Achievement 00:00:00

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 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.

The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

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.

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.

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.

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.

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.