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Risk Management Course for Clinical Research (London, United Kingdom - September 28-29, 2020) - ResearchAndMarkets.com

February 10, 2020 GMT

DUBLIN--(BUSINESS WIRE)--Feb 10, 2020--

The “Risk Management for Clinical Research” conference has been added to ResearchAndMarkets.com’s offering.

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

Risk management is becoming increasingly important to running clinical trials and ensuring compliance with regulatory expectations. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9 and the revised ICH GCP R2.

This essential two-day course will explain the importance of using risk management techniques in clinical research to comply with the latest focus on inspection in this area. It will show you how risk management can improve the quality of your clinical trials and demonstrate the importance of using risk analysis and risk management techniques in clinical trials and risk-based monitoring. You will learn how to identify, evaluate and implement specific risk-based techniques for risk management, including a clinical quality management framework.

The course will enable you to develop quality risk management principles applicable to clinical research, as well as to identify and share best practices for implementing risk management tools and approaches.

Benefits of attending:

Who Should Attend:

Anyone working on clinical trials including CRAs, monitors, clinical managers, project managers, lead clinical research associates, data managers, statisticians, study managers and those in QA/audit/QC and document management. It will also be relevant to those who work alongside the study team, such as regulatory affairs and pharmacovigilance.

Agenda:

Programme - Day one

Risk-based concepts and terminology

Outline of industry guidance and regulatory expectations

Importance and benefits of risk management

Risk management process

New proposed ICH risk-based quality management system (QMS) for clinical trials

Programme - Day two

Risk-based processes/tools and techniques

Risk-based approach to the protocol

Risk-based approach to monitoring

Brief review of risk-based approaches to QC/QA (auditing)

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 conference visit https://www.researchandmarkets.com/r/7ydjm8

About ResearchAndMarkets.com

ResearchAndMarkets.com 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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20200210005353/en/

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SOURCE: Research and Markets

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PUB: 02/10/2020 05:09 AM/DISC: 02/10/2020 05:09 AM

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