275 Pharmacology courses

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.

Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.

Overview of Control and Administration of Medicines In the ever-evolving landscape of healthcare, the control and administration of medicines stand as pillars of patient safety and well-being. The UK's healthcare sector is witnessing a surge in demand for skilled professionals adept in medicine management. With an ageing population and increasingly complex medical needs, the importance of effective medication control cannot be overstated. Recent statistics reveal that medication errors cost the NHS in England over £98 million annually and cause 712 deaths on average per year. This underscores the critical need for comprehensive training in the administration of medicines. Our course on Control and Administration of Medicines addresses this pressing need, equipping learners with the knowledge to navigate the intricate world of pharmacology and medicine management. From understanding the fundamentals of medicine management to exploring the nuances of palliative care, this course offers a thorough grounding in essential concepts. Delve into the four principles of medicine optimisation, unravel common pharmacological challenges, and gain insights into the legal landscape governing medication control. By mastering these crucial aspects, you'll be poised to make a significant impact in healthcare settings, enhancing patient outcomes and contributing to a safer, more efficient healthcare system. This Control and Administration of Medicines Course will help you to learn: Explain the fundamentals of medicine management and administration. Discuss the importance of effective medicine management. Demonstrate how to prescribe medication appropriately. Identify common medication problems and solutions. Recognises commonly used medicines. Apply principles of palliative care medicine. Apply the four principles of medicine optimisation. Manage medication in aged care facilities. Understand relevant laws and legislation. This course covers the topic you must know to stand against the tough competition. The future is truly yours to seize with this Control and Administration of Medicines Online Training Course. Enrol today and complete the course to achieve a certificate that can change your career forever. Details Perks of Learning with IOMH One-To-One Support from a Dedicated Tutor Throughout Your Course. Study Online - Whenever and Wherever You Want. Instant Digital/ PDF Certificate. 100% Money Back Guarantee. 12 Months Access. Process of Evaluation After studying the course, an MCQ exam or assignment will test your skills and knowledge. You have to get a score of 60% to pass the test and get your certificate. Certificate of Achievement Certificate of Completion - Digital / PDF Certificate After completing the Control and Administration of Medicines Online Training Course, you can order your CPD Accredited Digital / PDF Certificate for £5.99.  Certificate of Completion - Hard copy Certificate You can get the CPD Accredited Hard Copy Certificate for £12.99. Shipping Charges: Inside the UK: £3.99 International: £10.99 Who Is This Course for? Caregivers: Enhance your knowledge and confidence in medication administration for loved ones. Healthcare Professionals: Refine your skills and stay up-to-date with best practices in medication management. Pharmacy Staff: Deepen your understanding of medicines and their role in patient care. Community Workers: Equip yourself to support individuals in managing their medications effectively. Aspiring Healthcare Professionals: Lay a strong foundation for a rewarding healthcare career. Requirements There is no prerequisite to enrol in this course. You don't need any educational qualification or experience to enrol in the Control and Administration of Medicines Online Training Course. Do note: you must be at least 16 years old to enrol. Any internet-connected device, such as a computer, tablet, or smartphone, can access this online course. Career Path The certification and skills you get from this Control and Administration of Medicines Online Training Course can help you advance your career and gain expertise in several fields, allowing you to apply for high-paying jobs in related sectors.  Mental Health Nurse: £22K to £33K/year. Community Nurse: £35K to £45K/year. Pharmacist: £30K to £50K/year. Pharmacy Technician: £18K to £28K/year. Healthcare Assistant: £16K to £28K/year.   Course Curriculum Module 01: Medicine Management Fundamentals Medicine Management Fundamentals 00:37:00 Module 02: Importance of Medicine Management Importance of Medicine Management 00:25:00 Module 03: Prescribing Medication Effectively Prescribing Medication Effectively 00:27:00 Module 04: Common Problems - Pharmacological Management Common Problems - Pharmacological Management 01:05:00 Module 05: Common Medicines to Use Common Medicines to Use 00:18:00 Module 06: Palliative Care Palliative Care 00:24:00 Module 07: The Four Principles of Medicine Optimisation The Four Principles of Medicine Optimisation 00:00:00 Module 08: Managing Medication in Residential Aged Care Facilities Managing Medication in Residential Aged Care Facilities (RACFs) 00:35:00 Module 09: Law and Legislation Law and Legislation 00:25:00 Assignment Assignment - Control and Administration of Medicines Online Training Course 00:00:00

The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for marketing and sale in the USA.

This module aims to provide you with effective strategies for the preparation and conduct of a clinical trial, while adhering to regulatory safety standards. Management of data for submission is also covered.

The eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area, the USA and Canada. Other countries intend to make its use mandatory. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.

The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.

The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

This module outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.

This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.