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 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.
Completion of the ATP-CTP course is a prerequisite for taking the written knowledge test for the ATP certificate, and it is often a requirement for employment with airlines and other commercial aviation operators.
Duration 1 Day Certificate Validity 1 year Course Overview Experience the intensive QA Level 4 Award in Out Of Hospital Adults Immediate Life Support (RQF), a distinguished and nationally recognised qualification tailored for individuals entrusted with the responsibility of delivering emergency care in various settings, including event medical providers, emergency ambulance personnel, registered healthcare professionals, and specialized roles within the emergency services and military. This comprehensive course equips successful candidates with the knowledge and skills necessary to provide immediate life support to patients in cardiorespiratory arrest or facing life-threatening illness and injury. Topics covered include scene management, airway management, ILS procedures, treatment algorithms, modifications for specific scenarios like cardiac arrest during pregnancy, end of life care, and more. What’s Covered Mastery of scene management protocols Techniques for assessing and managing incidents effectively Management of patients with life-threatening or non-life-threatening conditions Post-incident procedures Proficiency in airway management techniques Immediate life support procedures, including: Return of Spontaneous Circulation (ROSC) Effective patient handovers Modifications required during cardiac arrest for specific scenarios such as third-trimester pregnancy and neck stoma Understanding immediate life support treatment algorithms Integration of end-of-life care principles Utilization of the National Early Warning Score 2 (NEWS2) Entry Requirements Participants must be at least 18 years old at the start of the training. Successful completion of the QA Level 4 Certificate in First Response Emergency Care (QCF or RQF) or an equivalent qualification, such as Associate Ambulance Practitioner or IHCD Ambulance Aid, is mandatory. Alternatively, registration as a healthcare professional working in an emergency care or primary care environment is accepted. Equivalent qualifications must align with the Learning Outcomes and Assessment Criteria of the QA Level 4 Certificate in First Response Emergency Care (QCF or RQF). These qualifications should be submitted to QA for review, demonstrating comparability in meeting the requisite skills, knowledge, and assessment standards. *Prices are not inclusive of VAT Course Information Venue: All our 'Open' courses are delivered from our dedicated training venue: Pulse South Coast Ltd, Bentley Wildfowl, Harveys Lane, Ringmer, BN8 5AF On occasion we may use a separate venue, this will be advised on the course booking. Facilities: On your course you will be provided with tea & coffee making facilities and biscuits. We are in a rural location so we recommend brining lunch with you on the day. There is a microwave & fridge on site for your use. There is a garage that is approximately a 10 minute drive from our venue. Parking: We have a dedicated car park that is approximately a 300m walk to the training venue. There is no additional cost to use this parking. We accept no responsibility for any personal loss or theft while you are on our training courses or premises. Please ensure to keep your personal belongings safe at all times. What is required from you: All courses are delivered in English, you must have a basic understanding of the English language to attend. There is a requirement for you to show that you are capable of performing the skills you are taught on the course, due to this you will need to be physically able to demonstrate all practical elements of the course. Dress: As a company we pride ourselves on running immersive & practical training courses. You will often be expected to kneel & work outdoors, please dress appropriately. Identification: As we deliver Ofqual accredited courses, there is a requirement for you to show a form of ID on the first day of the course. This could be; a driving license, passport or something that clearly shows who you are. Timings: All of our courses have a minimum training time of six hours a day, we will often advertise a course as seven hours to include break times. On occasion it is required to go over the scheduled times, however this will always be discussed with the group on the day. Trainer: During your course you will have a designated trainer for the duration. They are there not only to assess for the qualification, but to offer you guidance and support throughout. Security: We accept no responsibility for any personal loss or theft while you are on our training courses or premises. Please ensure to keep your personal belongings safe at all times.
Asbestos Awareness training is a legal requirement for any worker who may encounter asbestos during their work. Modules will provide relevant and detailed knowledge about the dangers of asbestos, the products that contain asbestos, what it looks like, where it may have been used and the practical steps that can be taken to reduce their risk of exposure. In addition to common mandatory modules, learners will also choose a selection of modules relevant to their occupational pathway.