An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials

Why Should You Attend:

If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this webinar will provide you with an overview of risk factors in clinical trials and possible ways to mitigate, control, assess impact, and prevent them in your trial. We would discuss the key elements of risk management such as planning, identification, quantification, action, measurement, outcome assessment, and post-implementation review of various types of risks. Also discussed will be best practices for risk analysis and prospective planning in the project plan. At the end of the course, you would be able to review your current project plan for potential issues or help address these factors in the future clinical trial project plans that you may create.

If you are aspiring to be a clinical project manager, are sponsoring a clinical trial, supervise clinical trial operations, or would like to become a clinical site, this course is a must for you.

Learning Objectives:

At the end of the seminar, the attendees will be familiar with the following:

• Most common issues with clinical trial initiation, execution and close-out.
• Best practices for risk analysis, management and prevention.
• Roles and responsibilities of various personnel in risk reduction.
• Incorporating short-term and long-term measures in project plans to manage risk.
• Processes to seek and document management decisions with regulatory implications.
• Do’s and Don’ts for risk management of a clinical trial.

Areas Covered in the Seminar:

• Common risk factors in clinical trials
• Retrospective and prospective risk analysis techniques.
• Risk management: Key techniques in risk reduction, assessment, addressing, training and communication.
• Risk analysis plan: identification, information gathering, decision, implementation and review.
• Overview of FDA requirements for risk management.
• Expectations and responsibilities of the clinical project manager.
• Role of various clinical team members: CRA, coordinators, sponsors and investigators.
• Challenges of large-scale and international clinical trials.

Who Will Benefit:

The following individuals or disciplines will benefit from attending this Webinar:

• Clinical Project Managers
• Clinical research associates
• Clinical coordinators
• Principal Investigators and sub investigators
• IRB personnel
• Regulatory Vice Presidents, Directors and Managers at sponsors
• Attorneys – In-house or Outside Counsel

Instructor Profile:

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( www.amarexcro.com ). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Background:

Managing clinical trials is arguably one of the most difficult jobs in the medical product development industry. Clinical trials are highly complex projects with numerous unpredictable factors that could influence their successful outcome. Several events could adversely affect a clinical trial outcome such as not being able to recruit subjects in a timely manner, managing difficult sites, trial supply issues, biological sample handling, regulatory trouble-shooting, and many more. A key component of clinical project management is the ability to identify potential risks and implementing measures to manage them. This seminar will provide the basics of clinical trial risk management and analysis techniques and practical tips to clinical trial professionals and sponsors using case studies from the presenter’s experiences.

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