Pharma Initiatives conducts a series of webinars to discuss challenging issues facing our clients. Links to past webinar videos and upcoming webinar registrations are found below:
Successful ICH E6R(2) Implementation Webinar
ICH E6(R2) is now GCP. For a Sponsor or CRO, implementing the risk identification and management components of E6(R2) successfully in your clinical development operations can be challenging. The temptation exists to treat this as a software implementation and trust automation vendors to drive the process change. That would be a mistake.
This webinar focuses on successful E6(R2) implementation, explaining why taking a software agnostic approach is more effective at this time. It will include best practices from the experience of Pharma Initiatives Consulting, as well as the practical experience of Rho, Inc. - a mid-sized CRO which has successfully implemented these changes.
CENTRAL MONITORING: A Practical Guide Webinar
ICH E6(R2) has ushered in an era of risk-based quality management (RBQM). Yet, many sponsors struggle with the aspect of RBQM that drives the most value - Central Monitoring. Pharma Initiatives has developed a practical guide for successful Central Monitoring based on its experience working with dozens of sponsors. In this one-hour webinar, Pharma Initiatives will share its Central Monitoring best practices, whether you control all the study execution or you outsource to CROs.
Exception From Informed Consent: 7 Keys to EFIC Study Success Webinar
Exception From Informed Consent (EFIC) studies have a distinct and challenging set of regulatory guidelines. While 21 CFR 50.24 provides the regulatory framework for EFIC studies in the US, implementing these regulations in practice is not straightforward. Pharma Initiatives has experience successfully assisting our clients through the EFIC planning and execution process. In this one hour webinar, Pharma Initiatives Partners Gary Tyson and Mark Shapiro share seven keys to success based on their experience.