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The 'Risk Management for Pharma and Biopharma Professionals Training Course' is an essential online training designed for professionals in the pharmaceutical and biopharmaceutical sectors. This comprehensive course emphasizes the significance of risk management techniques in clinical trials, particularly in ensuring compliance with regulatory expectations and enhancing the quality of clinical
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research projects. It covers the latest guidance from prominent regulatory bodies, including the ICH GCP R2 and R3 guidelines, as well as the FDA's Risk-Based Monitoring of Clinical Investigations. Participants will learn to apply a risk-based approach throughout the clinical trials lifecycle, focusing on critical aspects such as data integrity, participant safety, and regulatory compliance.
The course will delve into the principles of risk management, enabling participants to identify, evaluate, and implement specific risk-based techniques. Training will include the development of quality risk management principles applicable to clinical trials, pharmaceuticals, biopharma, and device development. Attendees will engage in discussions on best practices for risk management tools and approaches, including risk prioritization techniques, heat maps, and failure mode and effect analysis. The course will also highlight the importance of corrective and preventative actions (CAPA) in maintaining compliance and quality during clinical trials.
Dr. Laura Brown, a seasoned expert with over 20 years of experience in quality assurance and management of international clinical trials, will lead the course. She is a Senior Lecturer at the University of Cardiff and has worked with several prestigious companies, providing her with a wealth of knowledge on GCP and clinical trial requirements. Participants will benefit from her expertise as they explore key risk management terminology, regulatory guidelines, and the expectations of regulatory inspectors in clinical trials. The training will also feature interactive elements, allowing attendees to discuss and apply risk-based processes, tools, and techniques relevant to their roles in the industry. This course is tailored for professionals across various regions, including Malaysia and Russia, making it an accessible opportunity for those looking to deepen their understanding of risk management in clinical research.
The course will delve into the principles of risk management, enabling participants to identify, evaluate, and implement specific risk-based techniques. Training will include the development of quality risk management principles applicable to clinical trials, pharmaceuticals, biopharma, and device development. Attendees will engage in discussions on best practices for risk management tools and approaches, including risk prioritization techniques, heat maps, and failure mode and effect analysis. The course will also highlight the importance of corrective and preventative actions (CAPA) in maintaining compliance and quality during clinical trials.
Dr. Laura Brown, a seasoned expert with over 20 years of experience in quality assurance and management of international clinical trials, will lead the course. She is a Senior Lecturer at the University of Cardiff and has worked with several prestigious companies, providing her with a wealth of knowledge on GCP and clinical trial requirements. Participants will benefit from her expertise as they explore key risk management terminology, regulatory guidelines, and the expectations of regulatory inspectors in clinical trials. The training will also feature interactive elements, allowing attendees to discuss and apply risk-based processes, tools, and techniques relevant to their roles in the industry. This course is tailored for professionals across various regions, including Malaysia and Russia, making it an accessible opportunity for those looking to deepen their understanding of risk management in clinical research.
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Estimated Turnout100 - 500 Delegates Based on previous editions | Official LinksWebsiteContacts
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EditionsOct 2025 Interested+9 more editions Frequency Quarterly | Report Error Claim this event |
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