8191 Insights courses

Course Information Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. How is this course run? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. What will I learn? A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments Solid grounding in quality assurance activities aligned with regulatory standards Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues Clarity on the roles and responsibilities inherent to clinical trials auditing Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents A nuanced understanding of regulatory inspectors' activities Expanded professional networks to propel your auditing career forward. Benefits include: A clear understanding of the role of the auditor under Good Clinical Practice improved audits Improved Good Clinical Practice compliance for your clinical trials. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of Good Clinical Practice. Tutors Tutors will be comprised of (click the photos for biographies): Rosemarie Corrigan EVP Global Quality, Worldwide Clinical Trials Cathy Dove Director and Owner, Dove Quality Solutions Julie Kelly Associate Director, Clinical Quality Assurance, Corcept Therapeutics Susana Tavares Director of Research Quality Assurance, - Programme Please note timings may be subject to alteration. Day 1 12:30 Registration 13:00 Welcome and Objectives for the first day of the course 13:30 Laying the Foundations Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 Break 15:00 Patient Protection Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 Workshop 1 - Case Study on Informed Consent 16:45 End of Day Questions and Answers 17:00 Close of Day Day 2 08:50 Questions and Answers from Day 1 09:00 Effective Site Audits The procedures involved in selecting and setting up audits at investigator sites. 09:40 Workshop 1 - Planning the Effective Audit 10:30 Break 10:45 Source Data Verification The need for and purpose of verifying data. 11:25 Workshop 2 - Source Data Verification 12:30 Lunch 13:30 IMP Management The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 Critical Document Audits The conduct of other study specific audits including protocols, databases and reports. 15:00 Break 15:15 Non-compliance Determining the acceptability of data. 16:00 Fraud - Fact or Fiction? How to identify fraud and its consequences 16:45 End of Day Questions and Answers 17:00 Close of Day Day 3 08:50 Questions and Answers from Days 1 and 2 09:00 Auditing Third Parties A review of audits of contract research organisations. 10:00 System Audits The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 Break 11:00 Workshop 3 - Process Mapping 11:45 Effective Audits Where theory meets reality. 12:30 Lunch 13:20 Audit Reports - Closing the Loop An examination of the processes which follow the evidence gathering phase of the audit. 14:20 Workshop 4 - Audit Reports Audit reports, corrective and preventive action. 15:00 Break 15:10 Regulatory Inspection Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 Final Questions and Answers 16:10 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 17 Points Development Level Develop

Each week, participants will have the opportunity to gain invaluable insights, and hone their craft through immersive learning experiences.

We're passionate about equipping churches to respond to domestic abuse. Our Domestic Abuse Awareness course will help you explore key questions around the issue of domestic abuse, like how to recognise the signs of domestic abuse, why domestic abuse happens, and how to start supporting survivors.

Tackle Stress Before It Tackles You! Work-related stress affects 875,000 people every year, and its impacts go beyond the workplace—affecting your mind, body, and personal life. But it doesn’t have to be this way. Join our Stress Management Workshops to: ✔️ Understand the difference between stress and pressure ✔️ Learn the causes of stress in and out of the workplace ✔️ Discover practical coping strategies and build mental resilience These workshops are packed with insights, tools, and strategies to help you take control of your stress levels and improve your well-being—personally and professionally. There are two different ones to choose from - a 2 hour workshop and a 4 hour workshop! Course Contents of 2 hour course: What is Stress Stress versus Pressure Statistics Absenteeism, Presenteeism and Leaveism Workplace Causes of Stress Personal Causes of Stress Short-Term and Long-Term Effects of Stress Coping Strategies Mental Resilience Benefits of this Workshop: In 2022/23. 875,000 people suffered from work-related stress, depression or anxiety The affects of stress are far reaching, affecting one's mind, body, social and personal life Become more aware of what stresses you, what is does to you and find ways to reduce those stress levels

Experiential Group Process. A playground for therapists to nurture the imagination, release inhibitions and mobilise therapeutic insights. Unlocking Our-Selves: The Seekers Experiential Group and Process Work with Bárbara Godoy A playground for therapists to nurture the imagination, release inhibitions and mobilise therapeutic insights “Supportive, thought-provoking, emancipating, grounding” Inspired by the most prominent world seekers from antiquity to date. This year’s programme will take us on a profound personal journey of enquiry by cultivating presence and activating aliveness in the group environment OPTION 1: Tuesday Evenings Group 6 pm to 7.15 pm Term 3: Eastern Mystics 17and 24 September 1, 8, 15, 22 and 29 October 5, 12, and 19 November OPTION 2:  Friday Lunchtime Group 12.30 pm to 1.45 pm Latin American Writers 20 and 27 September 4, 11, 18 and 25 October 1, 8, 15 and 22 November Venue: Online – Zoom - Fee: £300 (term) Bárbara Godoy M.A., Adv. Dip. Exi. Psy. Existential Psychotherapist Group Leader, Counsellour, Lecturer and Supervisor, MBACP & UKCP accredited, SEA Professional Member, Director of Therapy Harley StreetBárbara’s academic contributions in London since 2008 include lecturing and researching on the theory and practice of Phenomenological Existential Therapy on Doctorate, MA and professional courses at the School of Psychotherapy and Counselling Psychology, Regent’s University and the New School of Psychotherapy and Counselling directed by Emmy van Deurzen. Bárbara has facilitated and designed therapeutic Group Work since 1997. She brought her earliest workshop: “Experiences” to large groups in The Netherlands, Italy, France, UK and Argentina. These awareness-intensive processes are a legacy of the human potential movement (HPM) of the 1960s, with techniques such as AUM Meditation Marathons, Psychodrama, Bioenergetics and Primal Feelings work.

LOOKING FOR: ADULT FICTION, NON-FICTION Daisy Chandley joined PFD in 2019 after graduating from the University of Oxford with a BA in Politics, Philosophy and Economics. She is an Associate Agent and assistant to Senior Agent Annabel Merullo and Head of Books Tim Bates as the UK sub-agent for New Directions Publishing in the US. Daisy is actively building a list of both fiction and non-fiction authors across a range of genres. With fiction, Daisy's wishlist roughly falls into three categories – if something feels like it overlaps between them, even better! 1) Sharp, original novels on the literary to upmarket spectrum, all the way from deeply dark and boundary-pushing books like Hurricane Season, Under The Skin or In The Cut to those balancing edge, heart and humour, like Detransition, Baby or A Visit From The Goon Squad. She loves irreverent wit, daring approaches in narrative or form, and seriously unsettling stories in equal measure, and if you can bring a few of those elements into one, it’ll go straight to the top of her. 2) Com-heavy rom-coms, whether in the dry but ultimately sob-inducing vein of Greta and Valdin or a Nora Ephron film, the escapist screwball delight of a Cary Grant classic, or the more unusual, genre-bending style of something like Palm Springs. Daisy is a sucker for Emily Henry and will always be happy to see an innovative take on tropey love stories, but is equally very keen to see to things a bit outside of the box, whether that’s integrating speculative elements, dark humour, or topical issues. In any case, humour and originality are my priority, and affectionately snarky bickering is the best way to make her fall head over heels with a couple. 3) Sleuths! Daisy is not the right person for police procedurals, but loves classic detectives and amateur sleuths. Whether it’s a delightful Knives Out or Nancy Drew homage or an intricate, unputdownable mystery on the darker side, the minute someone finds a good old fashioned clue, count her in! Overall, whether it’s a delightfully fun and scandalous page-turner or something really bold and experimental, if it’s stylish and smart – and maybe even a bit sexy – Daisy would love to see it. Daisy is definitely interested in literary speculative fiction, though not generally looking for hard SFF. Across the board, she is always looking for stories that explore sexuality, race, gender, and disability, and would particularly love to hear from writers whose voices and experiences aren’t given enough space in publishing. On the non-fiction side, Daisy is looking for bold new insights and underrepresented voices on popular science, nature writing, relationships, social issues and politics, and am always especially interested in fresh, playful and exciting writing on pop culture, love and the internet. She’d also love to see illuminating narrative non-fiction, whether a beautiful and lyrical exploration, or an enthralling and explosive deep-dive. A (large) handful of authors past and present whose work Daisy loves include Patricia Lockwood, Toni Morrison, Elif Batuman, Gillian Flynn, Shirley Jackson, Raven Leilani, Max Porter, Carmen Maria Machado, Virginia Woolf, Sayaka Murata, Kiley Reid, Sally Rooney, George Saunders, Joan Didion, Amy Liptrot, Ottessa Moshfegh, J.D. Salinger, Donna Tartt, Bret Easton Ellis, and Fernanda Melchor. Daisy is not the right fit for Children’s or YA authors.  Daisy would like you to submit a covering letter, 1 page synopsis and the first 2,500 words of your manuscript in a single word document. (In addition to the paid sessions, Daisy is kindly offering one free session for low income/under-represented writers. Please email agent121@iaminprint.co.uk to apply, outlining your case for this option which is offered at the discretion of I Am In Print).  By booking you understand you need to conduct an internet connection test with I Am In Print prior to the event. You also agree to email your material in one document to reach I Am In Print by the stated submission deadline and note that I Am In Print take no responsibility for the advice received during your agent meeting. The submission deadline is: Wednesday 26th February 2025

Historic Road Rallying training webinar on Regularity focusing on Average Speed Table style regularities.

Discover the world of Targa Rallies! Join our expert-led webinar to learn the basics, explore events and championships, and master timing, navigation, and special tests. Perfect for beginners!

Join us for an insightful masterclass that delves into the profound effects of neglect on a child's life. This session is meticulously designed for professionals working closely with children in various educational settings, providing essential knowledge and practical tools to identify, manage, and seek support for neglected children.

In an era where online presence is a necessity, understanding the fundamentals of search engine optimisation (SEO) is crucial for individuals and businesses alike.