Courses delivered Online

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

Embark on a transformative journey to become a qualified MHFAider®. Master your skills and learn how to spot and support people with mental health issues and make a difference whether at work, volunteering, or in your community.

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

Want learn how to use social media to market your business effectively? Join this short course from Let’s Do Marketing to learn how to create your social media strategy for success – and come away with the knowledge, skills and confidence to start connecting with your customers online!

A one-day training for counsellors, nurses, managers and healthcare practitioners who want to learn how to set up and facilitate Reflective Practice groups. Reflective Practice is the cornerstone of professionalism in healthcare. It develops clinical skills, improves decision-making, enhances work satisfaction, and reduces burnout.

This course will explain all aspects of the rules of origin and trade agreements and how to understand and comply with them to help companies be more competitive in export markets.

As the awareness of ADHD increases, more and more people are being diagnosed, or suspect they have ADHD. This workshop provides educators with an overview of what ADHD is, the challenges that people with ADHD face and strategies to help with learning and work.

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.

Learn to craft top-notch videos for your business using your mobile phone in this interactive workshop. Enhance marketing, visibility, and attract more clients through video. All-in-one workshop for diving into the world of business videos. #VideoCreation #BusinessBoost

Empower Mental Health First Aiders and Champions to maintain their skills with regular Refresher training. Just like physical first aid, we recommend that you refresh your skills every two to three years. (Certificate expires after 3 years). If it's time to update your skills, book onto an MHFA Refresher course now and feel confident that you are performing your vital role safely.