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Risk Based Clinical Trial Monitoring  

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Online Compliance Panel   

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The session is relevant for professionals working in pharmaceutical, biotechnology, CRO, regulatory authorities and study sites

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Seminar Summary:

Anyone who markets drug or dietary supplement products in the USA should be aware of the seriousness of an FDA Warning Letter and know how best to avoid receiving one. This webinar will provide recent examples of FDA Warning letters to convey an understanding of why companies receive them. Proactive and reactive strategies for responding to FDA Warning letters will be covered in this webinar. (see full course description)

 

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Training Course Syllabus:


Objectives of the Presentation

Understand the new requirements for risk based monitoring in clinical trials
Define the regulations and guidelines which cover risk based monitoring
Review of risk based monitoring approaches and methodology for clinical trial projects
Learn how to identify and evaluate risks for the investigator site and protocol for implementing risk based monitoring
Learn how to identify critical data
Evaluate the risk indicator and set thresholds
Consider how to implement this new concept within your organization
Hear best practice of these new risk requirements

Why Should you Attend

It is essential to comply with the latest GCP requirements to have a risk based monitoring methodology for your clinical trials. It is also essential to have a quality risk management system in place to allow for risk based monitoring. The FDA and EU regulatory authorities supports clinical trial sponsors to use risk-based site monitoring. For example, the revised ICH GCP guideline R2 Addendum, the EU Clinical Trial Regulation and FDA monitoring guideline all cover risk based monitoring.

This webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.

This webinar will explain:
The rationale for risk based monitoring
The requirements for risk-based monitoring and targeted source data verification (SDV) risks identification
Critical data and risk indicators analysis
The monitoring plan including risk monitoring and centralized monitoring
How to use risk based assessment for investigational sites and the protocol to implement risk based monitoring
Risk based monitoring roles and responsibilities

Areas Covered

Define risk based monitoring for clinical trials
Understand risk based monitoring tools and methodology used in clinical research projects
Explore the roles and responsibilities of those involved in risk based monitoring
How to plan risk based monitoring approaches for clinical trials
Understand how to identify and evaluate study site and protocol risks for targeted SDV
Develop and apply risk monitoring in your clinical trials
Learn how to document risk based monitoring in the monitoring plan

Who will Benefit

The session is relevant for professionals working in pharmaceutical, biotechnology, CRO, regulatory authorities and study sites including investigator initiated studies involved in clinical trials. It will also be of interest to those departments who liaise/support clinical trial personnel such as: Clinical Development Managers And Personnel, Clinical Operations Personnel, Clinical Research Associates, Clinical Research Archiving and Document Management Personnel, Quality Assurance Managers and Auditors, CROs using Laboratories to Analyze Clinical Trial Samples, Project Management, Sponsors and Non-Commercial Sponsors, Consultants, Laboratories Analyzing Samples from Clinical Trials, Regulatory Affairs Personnel, Legal and Regulatory Authorities

Seminar Summary:

Anyone who markets drug or dietary supplement products in the USA should be aware of the seriousness of an FDA Warning Letter and know how best to avoid receiving one. This webinar will provide recent examples of FDA Warning letters to convey an understanding of why companies receive them. Proactive and reactive strategies for responding to FDA Warning letters will be covered in this webinar. (see full course description)

print this agenda print agenda for the Risk Based Clinical Trial Monitoring training seminar

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