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.
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.
An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.
To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.
DevOps: The Next Evolution of Lean and Agile What is DevOps? Is it a new role? Self-service? More communication/empathy between Dev and Ops? Continuous integration/continuous deployment tools? Practices like traffic shaping and feature toggles? Culture change? Most of those answers are not wrong, but they fail to capture the heart of it. At its heart, DevOps is simply empowered development teams taking responsibility for how their product performs in production. If so, then this is not a new story. It's a continuation of the lean/agile trend which was the beginning of the end for quality assurance and business analysis as separate silos. This talk applies the lessons learned from leading lean/agile transformations to the current ongoing change toward DevOps. This and other IIL Learning in Minutes presentations qualify for PDUs. Some titles, such as Agile-related topics may qualify for other continuing education credits such as SEUs, or CEUs. Each professional development activity yields one PDU for one hour spent engaged in the activity. Some limitations apply and can be found in the Ways to Earn PDUs section that discusses PDU activities and associated policies. Fractions of PDUs may also be reported. The smallest increment of a PDU that can be reported is 0.25. This means that if you spent 15 minutes participating in a qualifying PDU activity, you may report 0.25 PDU. If you spend 30 minutes in a qualifying PDU activity, you may report 0.50 PDU.
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 Light Current Systems Light Current Fire Alarm System Part 1 00:17:00 Light Current Fire Alarm System Part 2 00:15:00 Light Current Fire Alarm System Part 3 00:18:00 Light Current Fire Alarm System Part 4 00:17:00 Light Current Fire Alarm System Part 5 00:17:00 Light Current Fire Alarm System Part 6 00:17:00 Light Current MATV System Part 1 00:14:00 Light Current MATV System Part 2 00:17:00 Light Current Telephone System 00:19:00 Light Current Data System Part 1 00:15:00 Light Current Data System Part 2 00:20:00 Light Current CCTV System Part 1 00:14:00 Light Current CCTV System Part 2 00:23:00 Light Current Sound System Part 1 00:18:00 Light Current Sound System Part 2 00:16:00 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
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 Supplementary Resources Supplementary Resources - Professional Certification in Spiritual Healing - Accredited 00:00:00 Foundations of Spiritual Healing Programme Overview 00:01:00 Aura, Chakra and Kundalini 00:04:00 Developing Key Spiritual Abilities Clairsenses 00:07:00 Barriers in Developing Clairsenses 00:03:00 Meditation to Remove Psychogenic Blocks or Filters 00:07:00 Meditation to Remove Spiritual Blocks or Filters 00:05:00 Mindfulness Exercises to Develop Clairsenses 00:04:00 Making Spiritual Diagnosis Diagnosing Imbalanced Chakras 00:13:00 Diagnosing Abnormal Aura 00:09:00 Step-by-Step Spiritual Healing Techniques Spiritual Healer Protection Techniques 00:13:00 Spiritual Healing, Energy Healing, and Reiki: Basics and Step-by-Step Tutorial 00:02:00 Angelic Healing: Basics and Step-by-Step Tutorial 00:02:00 Shamanic Healing: Basics and Step-by-Step Tutorial 00:04:00 Crystal Healing: Basics and Step-by-Step Tutorial 00:03:00 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
Level 7 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 180 CPD Points | Lifetime Access