Successful technology transfer in the manufacturing of pharmaceutical products is a stressful and expensive process that is fraught with risk. Whether you are moving from early R&D to producing product for clinical trials, scaling up commercial manufacturing, changing your process, or moving to an outsourced model, careful planning and execution is needed.
This session will be valuable to clinical trials and associated/related personnel looking for a foundational understanding of regulatory requirements, implementation, and best practices surrounding Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD).
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.
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