Webinars >>Clinical ​Risk Management
FDA Expectations for Risk-Reduction Practices in Clinical Trials
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Clinical trials are risky projects with numerous predictable and unpredictable factors that influence successful outcome. Risk could be expected events such as recruitment troubles, trial supply issues, biological sample handling; or unexpected events such as difficult sites, and regulatory emergencies. Any of the risk events could derail a trial. A key component of clinical project management is the ability to identify potential risks and implementing measures to manage them. This seminar will provide a comprehensive list of issues that could risk the success of a given clinical trial and best practices to mitigate, manage and prevent them.  
Why should you attend:

If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this seminar 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 seminar, 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.
Topics Covered in the Session:
  • 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
Learning Objectives:
  • 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​
Who will benefit:
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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
Data: October 29, 2018
Time: 12 PM EST
Duration: 60 Minutes

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com