Webinars

The price for all the webinars is $695.00 for up to 20 participants.

Writing Effective Monitoring Reports

DATE: Feb 7, 2019

Monitoring reports are a key part of documenting interactions with research sites and overseeing the progress of a clinical study. Clear, concise writing skills can streamline the report preparation process and facilitate the resolution of site issues. This 90-minute webinar, designed for experienced CRAs, will add professional polish to monitoring reports and letters.

Topics

  • Monitoring Communication & Documentation
  • Developing a Professional Writing Style
  • Resolving Action Items

ICH GCP E6 2016 Addendum

DATE: April 4, 2019

This 90-minute webinar offers an overview of the recent changes and additions to Good Clinical Practices. The 2016 addendum expands the guidelines for quality systems, risk-based monitoring, documentation, the sponsor’s oversight role, and the use of electronic systems in clinical studies. Participants will discuss how the new standards will affect their monitoring process.

Topics

  • Overview of the 2016 Addendum
  • Investigator: Resources, Data & Documentation
  • Sponsor: Oversight, Quality Management & Risk
  • Monitor: Monitoring Plans, Reports & CAPA
  • Risk-Based Monitoring
  • Electronic Systems

Overview of GCP Compliant Data Management

DATE: Oct. 11, 2019

This 90-minute webinar will identify the ICH GCP foundations of industry standard clinical trial data management practices, including the 2016 ICH GCP E6 R2 update. The principles of data integrity and the role of data management within the clinical study team will be explored. Recommended sponsor SOPs for data handling will be suggested. The webinar will also describe how GCP addresses recent advances in electronic medical data.

Topics

  • GCP Requirements for Data Management
  • Clinical Trial Data Flow and the Audit Trail
  • Data Management, Monitoring, and Safety Monitoring
  • Managing Electronic Source Data and Case Report Forms
  • Other Relevant Regulations and Guidelines

GCP for Global Clinical Trials: Japan

DATE: Sept. 12, 2019

Japan is one of the world’s largest markets for pharmaceuticals and medical devices. This 90-minute webinar begins with a brief overview of Japan’s regulatory agencies and ICH GCP as it applies to multinational studies conducted in Japan. The process by which foreign clinical studies may be submitted in support of a Japanese marketing application will be reviewed. Finally, students will discuss Japan’s regulatory challenges and progress towards greater international harmonization.

Topics

  • The Japanese Regulatory Environment
  • ICH GCP for Japanese Clinical Studies
  • Submitting Foreign Clinical Studies for Japanese Marketing Approval
  • Special Considerations for Global Trials in Japan

European Union Clinical Trial Regulation 536/2014

DATE: Nov. 7, 2019

The new European Union Clinical Trial Regulation (EU 536/2014) is scheduled to go into effect in October 2019. This regulation will replace the previous Clinical Trials Directive 2001/20/EC. This 90-minute webinar will cover significant changes between Regulation 536/2014 and the old Clinical Trials Directive, as well as the new regulation’s ties to ICH Good Clinical Practice. The requirements for foreign companies seeking to market medicinal products in Europe will be explored.

Topics

  • Challenges in Harmonizing European Clinical Trials
  • Differences Between Regulation 536/2014 and the Clinical Trials Directive
  • Submitting Foreign Clinical Studies for European Marketing Approval
  • CE Marking of Medical Devices
  • “Brexit” and Implementation of Regulation 536/2014 in The United Kingdom

Clinical Trial Operations Management

DATE: May 16, 2019

This webinar is designed for clinical operations managers, or for clinical professionals who are transitioning to a management role. The course will begin with the GCP responsibilities of the sponsor and investigator and then focus on the key metrics to managing monitoring resources, data management, with the final goal of lock.

Topics

  • The Sponsor-Investigator Relationship
  • Role of the Clinical Operations Manager
  • GCP Responsibilities
  • Metrics and trackers
  • Clinical operations management project flow.
  • Development of processes to enable efficient monitoring and data quality