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
Painting & 'glazing' means to add colour & patterns to your pottery. Kicking off with a practical demonstration, we will take you on a step-by-step journey of the fundamental ceramic techniques of glazing (surprisingly there are a few). Each step requires practice but you'll be hands-on in no time learning each step of the journey as we go. We have pre-made pots to choose from, inlcuding cups, bowls and planters. With your newly learned skills, you'll have what it takes to paint pottery and you can collect your finished works a few weeks later. We'll discuss when you can collect at the end of the workshop. All you need to do now is start thinking about your favourite colours and designs!
During pregnancy, hypnotherapy fosters a calm mindset, eases discomfort, and aids in preparing for childbirth (hypnobirthing). By harnessing the power of the mind-body connection, hypnotherapy proves advantageous in alleviating challenges when birthing fostering overall women's health and empowerment.
A whole day of workshops for groups of pupils throughout your school, delivered by a dedicated ally of disabled people. Engaging and thought-provoking, these workshops are a must for schools that want to challenge prejudice and promote disability equality. Workshops will help pupils to: learn more about disability and human rights hear disabled people’s perspectives identify common stereotypes and some of the prejudices disabled people face consider what disability is and how it arises understand the difference between impairment and disability review terminology and its effect on disabled people’s identities learn about disabled people who have made a difference ask sensitive questions anonymously become advocates for disability equality 95-100% of participants say that they found our workshop helpful Some of the reasons pupils have given for finding the workshop helpful are: “Until today I had always been scared of disabled people but today I have learnt that disabled people have a heart and emotions too.” “I now understand more about disabilities. My sister and brother has disabilities.” “It shows that although disabled people have limits they can do many things.” “Because presenter told in very simply way about complicated things and used interesting examples.” “Now I know that disabled people do things differently.” FAQs: How long is each workshop? 40-45 minutes; this can be adjusted to fit in with your school day. How many workshops will you deliver? We can deliver up to six workshops in a day. How many pupils should there be in each group? The workshops are interactive, so they are more effective with groups of around 20 pupils. We are often asked to work with larger groups and this still generates excellent feedback from pupils and staff. What year groups are these workshops for? The workshops are suitable for all year groups in primary and secondary schools; we adapt the content and presentation according to the age of pupils. Does a member of staff need to stay with the group? Yes, we ask that a member of staff is present at each workshop. Will you need any equipment? We ask for a computer, projector and access to the internet. Pupils will need a pen to write with. How are the workshops evaluated? At the end of each workshop we ask all (except the youngest) pupils to write down if they have found it helpful or not and why; we may also offer them an opportunity to ask a question anonymously.If schools have opted for this (please see optional extras below) we will send the school written responses to questions and a transcript of pupils’ feedback as evidence of impact. Cost: CSIE price: £800+vat plus expenses Optional extras: a) written responses to pupils’ anonymous questions (£50+vat) b) transcript of pupils’ feedback, as evidence of impact (£50+vat)
Authentic Art workshops led by a local artist.
Discover effective strategies for using hypnotherapy with children experiencing common disorders and challenges in our comprehensive workshop. We blend Western medical insights with holistic approaches to provide a well-rounded understanding and practical tools for supporting children's holistic development.
This workshop takes a holistic approach, integrating hypnosis with evidence-based practices, ensuring you have a comprehensive toolkit to support individuals on their journey to IBS relief. Whether you're a seasoned hypnotherapist or new to the field, this workshop provides you with the essential skills and knowledge to make a profound difference in the lives of those struggling with IBS.