Date: October 12 (1 day)
Price: 6900 SEK per participant
Place: Physically at Hälsingegatan 40 in Stockholm (limitation of 12 participants) or Digitally
Course language: English
Diploma: Certificate is awarded after completion of the course
This comprehensive 6-hour course provides in-depth knowledge of Good Clinical Practice (GCP) principles, ensuring thorough understanding and adherence to the ethical and scientific quality standards for designing, conducting, recording, and reporting trials involving human subjects. The course covers fundamental topics like the history and importance of GCP, roles and responsibilities of clinical trial stakeholders, informed consent procedures, trial design, data management, and safety reporting. Attendees will also be introduced to regulatory guidelines, quality assurance processes, and the effective utilization of the latest tools and technologies in clinical trials. The course equippes attendees with the skills necessary to maintain the rights, safety, and well-being of trial subjects, ensure data integrity, and navigate the complex regulatory environment of clinical trials, thereby making a significant contribution to the conduct of high-quality, ethical clinical research.
The lecturer for this course is Rekaut Naderipour, a renowned clinical trial expert with a decade-long career in the field. Rekaut is also the founder of RecQ Oy, Finland’s fastest-growing clinical trial consultancy, and has been recognized as the Clinical Research Associate of the Year 2023 by Pharmaca Oy, Rekaut brings unrivalled expertise to the domain of Good Clinical Practice (GCP) and Clinical Trials Management & Monitoring. With extensive experience working in diverse roles across multinational pharmaceutical corporations and innovative biotech startups, in three distinct European countries, Rekaut’s depth of knowledge is exceptional. This broad perspective enhances the practicality and relevance of each training session. Notably, Rekaut’s career as a Clinical Research Associate and Clinical Study Director has allowed for the collection of an extensive understanding of industry practices and ethics.
Beyond this, Rekaut has an impressive knowledge of Quality Assurance and QA processes. Having successfully conducted internal audits for pharmaceutical companies in Germany, and has been audited and inspected by pharmaceutical companies, EMA, FIMEA and FDA. Rekaut brings an understanding of the critical role of quality in the clinical trials space into the lectures with him. Rekaut’s extensive experience is reflected in the training sessions, offering participants a comprehensive, and practical perspective on quality assurance in clinical trials with real life examples. The goal is not merely to educate about GCP but also to guide towards a comprehensive understanding of the complex risk landscape within clinical trials, fostering a culture of preparedness and proactive problem-solving within a company.