Brexit planning is beginning, but there are many questions in the pharmaceutical and biotechnology industries about what happens between now and when the United Kingdom officially leaves the European Union. Join our 90-minute interactive webinar for an overview of Brexit’s potential impact to current EU clinical development regulations and come up with a plan to be ready!
While pharmaceutical and biotech companies outsource clinical trial tasks to CROs, Sponsors retain responsibility for the safety of subjects and regulatory requirement compliance and must ensure that the CRO is managing the trial correctly. Join our 90-minute interactive to identify the steps of conducting an effective audit to determine a CRO’s compliance to GCP requirements, study protocol and CRO/Sponsor Contractual Agreements.
These seven sessions are intended to give participants a foundational understanding of the recent changes to ICH GCP E6 through the R2 addendum. You will gain a fundamental understanding of major changes to the guidance, plus major differences between the previous and current version. You will learn what’s new, what’s important, and how to update your efforts. This program will be beneficial to literally anyone working with clinical trials.
The recent update to ICH GCP E6 (R2) emphasizes the use of “smarter” onsite, remote and centralized monitoring practices. Join our interactive live webinar to receive a practical guide to implementing an effective monitoring plan.
Investigator Oversight is essential to running an effective, compliant clinical trial. New ICH GCP E6 (R2) guidelines suggest changes in how this should be done. Join us for this interactive session to learn more.
Do you have a system in place to prevent noncompliance and to ensure effective action planning with follow-up in the event of a significant deviation? The ICH E6 GCP updates expects that you do!
Attend our webinar training on the essentials of CAPA and Root Cause Analysis to apply to your clinical trials!
The new revision of ICH E6 Guidelines (R2 Addendum) focuses on updating and clarifying standards for sponsor and investigator oversight, quality data characteristics, electronic records and essential documentation. Join our webinar to learn about the major updates to train your team and be ready to implement the guidelines.
With the release of ICH E6 R2 GCP update, risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Join us for this 60- minute presentation and be taken through a clinical trial case scenario applying a sponsor oversight plan.
Good Documentation Practices are essential to a clinical trial’s success. New ICH GCP E6 (R2) guidelines provide updates and clarity to GCP definitions for documentation. Join us for this interactive session to learn more.
Quality Risk Management (QRM) is essential to running an effective, compliant clinical trial. New ICH GCP E6 (R2) guidelines suggest changes in how this should be done. Join us for this interactive session to learn more.
In this session, you will develop the tools to set-up your hypotheses, identify the correct test to use, complete the test, and make your decision on the hypothesis in question. The course will show you how to translate your statistical answer into one that makes sense in the real world.
Process and approaches to performing risk assessment in a GCP setting is covered in detail in this session, which is a “must have” to support the transition to clinical quality systems, including clinical quality risk management.
This session focuses on applying a critical thinking technique to confidently address the hard questions regarding informed consent process management. It will give you practical answers to frequently-asked best practice questions related to monitoring informed consent by applying GCP and critical thinking techniques.
This course will provide attendees with clear, practical answers to Frequently Asked Questions about Monitoring Electronic Health Records (EHR). Common confusion points about site requirements for source documentation and sponsor monitoring of electronic health records will be discussed in detail.
This course will help you navigate confusing HIPAA requirements and provide solutions to ensure patient data security. Through instruction and value-added documentation, you will walk away with actionable knowledge to keep your efforts compliant, and have the ability to separate fact and fiction.
This course provides a road map to regulatory and global guideline GDP requirements applied specifically to good clinical practices (GCP) that you can adopt and adapt to your global clinical operations.
