10882 Professional Development courses in Rhyl delivered On Demand

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.

Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. The rules may be written into law or set out in guidance documents from regulatory authorities. Regulators will not allow medicinal products to be placed, or to remain, on the market in their country unless the products can be shown to be manufactured in compliance with GMP. To this end, they carry out inspections of manufacturing plants. Companies that persistently commit serious breaches of GMP requirements have suffered huge fines.

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.

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.

The First Aid for Drivers (including baby and child First Aid) course is designed to give you the theoretical knowledge (and a lot more) needed to learn vital skills to be able to assist in road related medical injuries. This course is an excellent First Aid Training package for people to gain this invaluable knowledge as to how to help an adult, baby or child involved in a road traffic accident. The course covers topics such as CPR, the recovery position, choking, bleeds and so much more. The course consists of illustrated step by step directions, flow charts, diagrams, videos and test yourself sections fully compatible with all computers and mobile devices. You will be able to stop and start as often as you like and print your Certificate on completion. You will have continuous access to the course for 12 months. It is impossible to cover all eventualities within this course, or to equip you with the knowledge and skills to appropriately diagnose and treat in unpredictable real life situations. If you suspect serious illness or injury, you should always seek immediate professional medical advice. The Author has made every effort to ensure the accuracy of the information contained within the course, however this course is merely a guide and the Author does not accept any liability or responsibility for any inaccuracies or for any mistreatment or misdiagnosis of any person, however caused. The course material has been written by Emma Hammett, Qualified Nurse, First Aid Trainer and founder of First Aid for Life in conjunction with other medical and first aid professionals. If you have any queries concerning this course, please contact emma@firstaidforlife.org.uk Course contents: Action in an emergency Role of the First Aider The Primary Survey – How to help in an Emergency Unresponsive and Breathing Recovery Position Secondary Survey Heart Attack and Angina Unconscious and not breathing Resuscitation Breathing Problems Choking Asthma Panic Attacks and hyperventilation Anaphylactic Shock Wounds and bleeding Shock Fainting Burns Breaks, Sprains and Dislocations Head Injuries Spinal Injuries Log rolling someone into recovery position Major Crush injury – 15 minute rule Road Traffic Accidents Fitting / Seizures / Convulsions Extremes of body temperature Medical conditions Diabetes

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. Course Curriculum Module 01: Introduction Module 01: Introduction 00:04:00 Module 02: Learning Disability and Mental Health Module 02: Learning Disability and Mental Health 00:10:00 Module 03: Causes of Learning Disability Module 03: Causes of Learning Disability 00:14:00 Module 04: Legal Framework on Learning Disability Module 04: Legal Framework on Learning Disability 00:21:00 Module 05: Challenging Behaviour of Adults with Learning Disabilities Module 05: Challenging Behaviour of Adults with Learning Disabilities 00:11:00 Assessment Mock 1 Assessment Mock-1-Learning Disability Nurse 00:10:00 Module 06: Protecting People with Learning Disabilities Module 06: Protecting People with Learning Disabilities 00:00:00 Module 07: Assessment and Diagnosis of Learning Disability Module 07: Assessment and Diagnosis of Learning Disability 00:19:00 Module 08: Learning Disability Nursing Module 08: Learning Disability Nursing 00:09:00 Module 09: Different Approaches to therapy Module 09: Different Approaches to therapy 00:18:00 Module 10: Physical Health Issues with Down's Syndrome Module 10: Physical Health Issues with Down's Syndrome 00:15:00 Assessment Mock 2 Assessment Mock-2-Learning Disability Nurse 00:10:00 Module 11: Mental Health Issues and Epilepsy Module 11: Mental Health Issues and Epilepsy 00:18:00 Module 12: Access to Health Care Module 12: Access to Health Care 00:12:00 Module 13: Role of the Learning Disability Nurse Module 13: Role of the Learning Disability Nurse 00:10:00 Module 14: Professional and Legal Issues Module 14: Professional and Legal Issues 00:19:00 Module 15: The Future of Learning Disability Nursing Module 15: The Future of Learning Disability Nursing 00:10:00 Assessment Mock 3 Assessment Mock-3-Learning Disability Nurse 00:10:00 Final Assessment Final Assessment - Learning Disability Nurse 00:10:00 Conclusion Conclusion 00:04:00 Obtain Your Certificate Order Your Certificate of Achievement 00:00:00 Get Your Insurance Now Get Your Insurance Now 00:00:00 Feedback Feedback 00:00:00