Risk Based Monitoring Compliance - New Requirements - What do the FDA and EU Inspectors Expect

This webinar will help attendees understand the important compliance requirements concerning the new risk-based approaches to monitoring clinical trials. It will discuss an overview of the regulatory requirements for how risk-based monitoring should be carried out, how it is defined across the world, and more importantly how it will affect compliance for monitoring clinical trials.

Why Should You Attend:

Are you up to date with the new risk-based approaches to monitoring?

FDA and EU inspectors now endorse risk-based trials approach. Risk based monitoring should raise the standards of monitoring but also save money as on site monitoring should be reduced. The concept of centralized monitoring is now considered a beneficial approach that is accepted by the FDA.

This webinar will take you through the most important approaches to carrying out risk-based monitoring for clinical trials in the US and globally. Attending this web seminar will help ensure you are familiar with the new requirements for monitoring clinical trials and be able to implement the risk-based monitoring requirements to comply with the increasing standards in this area. It will highlight the most important of these key requirements and changes and how these are likely to impact on trials for pharmaceutical companies, CROs, vendors and study sites.

This webinar will enable you to successfully prepare for and execute risk-based monitoring plans. Regulatory inspectors will expect those involved in clinical trials to be using risk-based monitoring– this essential course will also be ideal for this and disseminating the information to your staff and colleagues to be prepared for these important changes.

Areas Covered in the Webinar:

Practical advice for successful implementation of a risk-based approach to monitoring clinical trials

The risk based monitoring approach

• Definitions of risk and compliance risk
• Requirements for risk management
• The responsibilities of risk, audit and compliance compared – where should boundaries be drawn

Latest regulatory developments in risk based monitoring

• FDA
• EMA quality systems and risk based monitoring
• Understand the FDA, EU and global risk-based monitoring requirements

Preparing the monitoring plan

• Structure of the plan
• What it should contain and who should review this

Risk monitoring approaches

• Identify how risk management can be applied in study management and monitoring of clinical trials
• Define key risk indicators that aid decision making in monitoring and SDV
• How risk-based monitoring should be carried out
• Consider how to reduce the risks and costs associated with monitoring your clinical trials
• Understand risk-based compliance monitoring approaches
• What is centralized monitoring?
• Understand the impact on the monitoring and CRA roles
• Get to grips with key risk management concepts and methodologies
• Understand the regulatory expectations to ensure compliance
• What you need to know about regulatory inspections for the new risk-based regulatory requirement

Who Will Benefit:

This webinar will provide critical assistance to FDA and EMA regulated companies including professionals in pharmaceutical, biotechnology, CRO, SMO, vendor companies, or study sites including investigator initiated studies. This course is relevant to anyone who would like to develop a better understanding of a risk-based approach, including (but not limited to) Heads/Directors/Managers/Specialists from the following departments:

• Clinical Monitoring
• Clinical Operations
• Data Management
• Study Management
• Clinical Development Managers and Personnel
• Clinical research associates
• Quality assurance managers and auditors
• Clinical Development managers and personnel
• CROs
• Project Management
• Sponsors and non-commercial sponsors
• Consultants
• Clinical Trial Supply
• Pharmacovigilance
• Legal, regulatory authorities

Instructor Profile:

Dr. Laura Brown, PhD, MBA, Diploma Clinical Sciences, is an independent QA and Training Consultant in the Pharmaceutical Industry as Managing Director LB Training and Development Ltd. , Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff, and Course Director MSC Regulatory Affairs, TOPRA.

Dr. Brown has almost 20 years’ experience of running clinical trials and clinical quality assurance in the pharmaceutical industry, including auditing and monitoring clinical trials internationally and using risk based monitoring.