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Yahoo
06-06-2025
- Health
- Yahoo
Clinical Trial Monitoring Online Training Course: July 21-22, 2025 - Gain Insights Into How New Monitoring Approaches are Shaping the Future of Clinical Trials
Dublin, June 06, 2025 (GLOBE NEWSWIRE) -- The "Clinical Trial Monitoring Training Course" training has been added to offering. With regulatory inspectors increasingly finding GCP issues with monitoring clinical trials, it is becoming even more important for the biopharmaceutical industry, study sites, and CROs to employ efficient and accurate strategies for monitoring clinical trials. Also, the global COVID-19 pandemic has changed the ways clinical trials are monitored and resulted in remote and centralized monitoring techniques at the forefront of monitoring. This has created an environment that requires monitors to not only purely focus on site visits. Regulatory authorities promote these alternative ways of monitoring trial data and the future is likely to include a more hybrid monitoring approach. This highly interactive course, which includes group discussions, ensures that monitors not only understand the importance of compliance with the latest GCP standards but also gain insights into how new monitoring approaches are shaping the future of clinical trials. Benefits of Attending Ensure GCP compliance for monitoring clinical trials including during Covid and monitoring approaches for the future Evaluate the development of monitoring plans through protocol analysis for remote risk management Discuss tools and risk evaluation approaches for remote monitoring Ensure appropriate site selection, initiation, monitoring, and close out visits are carried out including during a pandemic Review sponsor and CRO oversight of monitors Certifications CPD: 12 hours for your records Certificate of completion Who Should Attend? Monitors Clinical research associates (CRA) Clinical trial managers Study coordinators Project managers Research nurses Study site assistants Those responsible for oversight of monitoring Investigators seeking to move into clinical trial monitoring This course will benefit those involved in the monitoring of clinical trials, including new and soon-to-be monitors. This will also be an ideal refresher including how monitoring has changed because of the pandemic and those responsible for oversight of monitors. Key Topics Covered Day 1 ICH GCP R3 Compliance considerations for monitoring clinical trials for the future What is the role of the monitor/CRA to comply with GCP and changes as a result of the pandemic and technological advances? The monitoring role in the context of having a quality system for clinical trials ICH E6R3 and update and impact on monitoring Site selection Criteria for selecting suitable sites Site Feasibility Assessment Site initiation Preparing for site initiation Agenda and content of site initiation visit report to comply with GCP Risks of inappropriate site initiation & resulting issues Monitoring visit procedures Preparing for site monitoring Important consideration during SDV and virtual clinical trials Identifying issues and developing solutions Monitoring visit report to comply with GCP Day 2 Study close-out visits Preparing for site closure Final preparing of documentation and entering data Content of closeout visit and follow-up to comply with GCP Planning Patient recruitment strategies Optimising recruitment to clinical trials Common recruitment problems in clinical trials and how these may be managed Oversight of monitoring Co-monitoring visits including by the sponsor and CRO management Preparing a sponsor monitoring oversight visit Follow-up with the monitor/CRO GCP, documentation and archiving Requirements of the GCP Inspectors TMF considerations Reporting serious breaches and preventing fraud: what monitors need to know What are the signs a monitor should look for serious breaches and fraud? What actions should the monitor take? How to report serious breaches Preparing for audit and inspection visits to comply with GCP How to prepare effectively for a study site audit and/or regulatory inspection What do QA departments and inspectors look for? A brief review of regulatory authority inspections findings SpeakerLaura Brown Pharmaceutical QA and Training Consultant, University of Cardiff Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years' experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
28-05-2025
- Health
- Yahoo
GCP (Good Clinical Practice), Clinical Research and Inspection Training Course: Regulatory Compliance, Recent Legislation, and Technological Advances (ONLINE EVENT: July 7, 2025)
Stay ahead in clinical research with our essential course on EU Clinical Trials Regulation and ICH GCP R3 updates. Benefit from expert insights on regulatory compliance, recent legislation, and technological advances. Earn 6 CPD hours and a completion certificate. Reserve your spot today! Dublin, May 28, 2025 (GLOBE NEWSWIRE) -- The "GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course" training has been added to offering. Clinical research is a constantly evolving field and the regulatory requirements are frequently being updated. In order to stay ahead and maintain your GCP knowledge, it is important to receive regular training. This must-attend course provides a review of recent changes to relevant guidance and legislation and will look at how these developments have been implemented and are likely to be implemented. Topics covered will include the EU Clinical Trials Regulation and associated documents and an update on ICH GCP R3 This is a highly interactive course suitable for those who need to refresh their knowledge and to demonstrate recent and up-to-date training to regulatory inspectors. Who Should Attend: The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance, QA, Audit, CROs, academic trialists and regulatory inspectors. It will also be of interest to those departments who liaise/support clinical trial personnel and all other professionals who want to know more about updates in GCP regulations and guidelines covering clinical trials. Benefits of attending Be updated on ICH GCP R3 Discuss recent developments in GCP and clinical trial legislation and guidance in the EU, FDA considerations Review the requirements of clinical trail essential documentation Identify common audit and inspection findings to help prepare for inspection Understand the EU Clinical Trial Regulation requirements Clarify requirements for data integrity and governance Explore technology advances in clinical trials Certifications: CPD: 6 hours for your records Certificate of completion Key Topics Covered: Brief review of regulatory authority inspection findings EMA, MHRA and FDA findings New ICH GCP E6 R3 draft guideline What is new and likely to impact on running trials Revised principles Data governance Records and reports Key updates, additions and revisions ICH E8 Other ICH updates European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs) ICH E8 Data integrity governance What inspectors look for MHRA integrity guidance compliance ICH GCP R3 Governance requirements EU Clinical Trial Regulation (536/2014) update Key changes and documentation Update since go-live Clinical Trials Information System (CTIS) EU clinical trial authorisation Serious Breaches Essential records: EMA key requirements to avoid inspection findings, and documents requirement in ICH GCP E6 R3 TMF structure, content, security, control, maintaining the TMF and storage, e-TMFs, archiving and retention ICH GCP R3 - recommended format for compliance Awareness update from EU and FDA EU EMA Guidance on validation & qualification of computerised systems European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs) Artificial intelligence reflection guidance in lifecycle Stronger enforcement of the GDPR in cross-border cases Real-world data FDA Guidance for industry: considerations for the use of real-world data FDA guidance on enhancing the diversity of clinical trials A risk-based approach to monitoring of clinical investigations Informed consent guidance for IRBs, clinical investigators and sponsors Digitalisation and technology advances and GCP Technology innovations in clinical research Electronic informed consent Apps, medical devices and mobile technologies in clinical trials Artificial intelligence Decentralised clinical trials Conclusion and final Q&A Speakers: Laura Brown Pharmaceutical QA and Training Consultant University of Cardiff Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years' experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
