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Here’s your starting point to a rewarding and successful career in compliance! Learn the ins and outs of compliance for the financial services industry with LGCA and become a certified professional member of the fastest growing GRC association out there.

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

Begin your journey in compliance management with practical knowledge of the laws and legislations that make up the regulatory field in the United Kingdom. Do you know that FCA sets an annual CPD requirement both for senior managers and employees of financial service firms? As per TC 2.1.15 & 2.1.16, the requirement is 35 hours in each 12 months, including 21 hours of structured CPD activities. Furthermore, TC 2.1.20G27/05/2022 defines structures CPD activities as follows: “Examples of structured continuing professional development activities include participating in courses, seminars, lectures, conferences, workshops, web-based seminars or e-learning.” Our FCA Compliance Essentials Bundle, fulfilling and even exceeding the FCA requirement in terms of CPD hours, is ideal for any professional within Financial Services. Study method Online, self-paced Course format Video with subtitles Duration 40 hours Qualification No formal qualification CPD 40 CPD hours / points Certificates Certificate of Completion - Free Description LGCA's FCA Compliance Essentials eLearning library currently includes the following courses (new courses are added on a regular basis): AML Risk Assessment AML Suspicious Activity Reports and Suspicious Transaction Reports (SAR/STRs) Anti-Bribery and Corruption Anti-Money Laundering and Counter Terrorist Finance Approved Persons Regime Assessing and Managing AML Risks Building an AML Risk-based Approach CASS Introduction Complaints Handling Compliance Introduction Compliance Monitoring and Testing Conduct Rules for All Staff Conflict of Interest (COI) Consumer Duty Establishing and Maintaining a Strong CDD Programme Ethics, Integrity and Fairness in Financial Services FCA: the Role and Approach Financial Promotions Regulation Fraud Detection and Prevention GDPR Awareness Introduction to Cybersecurity Introduction to Know Your Client (KYC) and Customer Due Diligence (CDD) Market Abuse (MAR) Operational Resilience Senior Managers and Certification Regime SM&CR – The Conduct Rules Suspicious Transactions/Activity Reporting The Value of Customer Due Diligence (CDD) Treating Customers Fairly Vulnerable Customer Management Whistleblowing Creating a Compliance Culture in Financial Services Who is this course for? Financial Services Providers Accounting Offices Financial Institutions Brokers Wealth & Fund Managers Investment Firms Insurance Companies Law Firms Compliance Consultants Payment Solutions Providers FinTech & RegTech Companies Fiduciary Services Firms

This training is designed for lawyers and covers key topics to ensure compliance with the Specialist Quality Mark (SQM) and other regulations.

session will take you from zero knowledge expectation to a through understanding of everything from Equity and ECM through to Derivatives and the syndicate desk.

Description FCA Compliance Essentials Begin your journey in compliance management with practical knowledge of the laws and legislations that make up the regulatory field in the United Kingdom. Do you know that FCA sets an annual CPD requirement both for senior managers and employees of financial service firms? As per TC 2.1.15 & 2.1.16, the requirement is 35 hours in each 12 months, including 21 hours of structured CPD activities. Furthermore, TC 2.1.20G27/05/2022 defines structures CPD activities as follows: 'Examples of structured continuing professional development activities include participating in courses, seminars, lectures, conferences, workshops, web-based seminars or e-learning.' Our FCA Compliance Essentials Bundle, with an overall duration of about 40 hours, fulfils and even exceeds the FCA requirement in terms of CPD hours and is ideal for any professional within Financial Services. Enroll now and enjoy a special price! Who should attend? Banks' managers/officers Investment Services Companies managers/officers Insurance Companies managers/officers Listed Companies managers IT managers/officers of companies developing IT systems/applications for financial institutions in order for them to meet the regulatory requirements Lawyers Officers exercising control activities (internal auditors, inspectors, external auditors, operational risk managers etc) Professionals wishing to work in Compliance in the future Graduate or post graduate students. Professionals that wish to make an international career in Compliance and would like to have a broader picture of how Compliance works and its methodologies, at international level. Compliance Officers Risk Managers MLROs

Ensure your organization adheres to regulations and ethical standards with compliance management. Learn how to navigate regulations, mitigate risks, and maintain ethical standards effectively. Enrol now to protect your organization's reputation and ensure regulatory compliance.

By completing this course, students will appreciate the importance of compliance and risk management for governance, strategy, and operations. They will acquire skills to establish compliance programs, promote ethical cultures, and use risk management techniques in their own organisations.

Here’s your starting point to a rewarding and successful career in compliance! Learn the ins and outs of compliance for the financial services industry with LGCA and become a certified professional member of the fastest growing GRC association out there. Every organization faces a myriad of risks that can threaten its operations, reputation, and bottom line. A robust, effective compliance program can make the difference between companies that successfully navigate those risks, and those that become cautionary tales. Faced with increasingly regulated environment, this programme offers insight into good compliance practices and the skills to lead effective compliance programmes that supports ethical conduct and commitment to compliance. Study method Online, self-paced Duration 25 hours Access to content 360 days Certification Certificate in Compliance Additional info Exam(s) / assessment(s) is included in price Description This certificate programme will introduce the essential elements of effective organizational compliance by exploring the concepts, considerations, and strategies for assessing risks and managing the compliance function. You will learn the fundamental principles of effective compliance, the components of an effective compliance program and their applications. In addition, you will explore the foundational principles of compliance: what are the sources of compliance requirements; where are the requirements found; what behavior satisfies “compliance;” and how do compliance personnel motivate compliant behavior throughout their organization. Expected Learning Outcomes By acquiring the Certificate, participants are expected to be able to: • Comprehend and maintain awareness of compliance requirements • Organise and monitor the operation of compliance management system • Implement processes for the management of breaches in compliance requirements • Provide education and training on compliance requirements and systems • Promote and liaise on compliance requirements, systems and related issues • Promote compliance with a sound understanding of the requisite legislation • Show leadership in the workplace • Identify risk and apply risk management processes • Manage projects • Undertake compliance audits Certificate Content Compliance • Compliance Programs • Compliance Perspectives • Why do we Need Compliance? International Regulatory Landscape • Key Elements • Principle based Vs Rules Based Approach • Market Forces • Regulation and Practice Compliance in Practice • The role of the Compliance department • The role of the Compliance Officer • The role of the Board • Key compliance activities and processes • Key compliance relationships Ethics, Compliance and Governance Perspectives • Ethics • Compliance • Governance Other Key Compliance Areas • Anti-money laundering • Financial crime prevention • Managing risk • Enforcement Certificate Format • Register at any time for this online, open certificate • Study in your own time and at your own pace (you have up to 3 months to complete the certificate) • Assessed by online multiple-choice exam Exam Format • Type: Multiple choice, closed book online exam • Duration: Two hours • Pass mark: 70% • Number of questions: 100 What is included • 25 hours of self-paced online interactive learning including analysis of 4 practical case studies • 1-year free AGRC membership • Practice Questions • Online Exam and AGRC Certificate Who is this course for? Staff working in or aspiring to work in the compliance area New graduates from any discipline Staff involved in risk functions and internal or external audit Those wanting to build a career in compliance in the fields of: Banking – Insurance – Other financial services Requirements No previous knowledge or experience is required though it is assumed that participants have good knowledge of English and sound educational background. Career path Compliance Officer, Head of Compliance, Compliance Director

📢 Stay ahead in the world of compliance with Compete High’s Certificate in Compliance! 🏆 Learn key concepts, risk management, and ethical standards in an engaging online course. Study at your convenience and earn a certificate! 🎓💼