Webinar: How Companies are Transforming Clinical Operations in Light of ICH E6 (R2)
Thursday, March 8, 2018 | 11:00am-12:00pm EST
Risk-based processes have always been a part of the pharmaceutical industry, especially within the GMP segments. However, the ICH E6 (R2) addendum has now mandated risk-based approaches be a part of clinical trial operations as well, and the latest research and experience helping companies implement remediations has shown that the industry is not well prepared to deal with the required changes. This webinar will review the key changes for ICH E6 (R2), discuss the challenges organizations are facing, as well as the positives steps they are taking to adapt current practices to be compliant with the amended regulations.
- Gain insight into how companies are modifying their standard practices to reach ICH E6 (R2) compliance
- Learn key challenges organizations face in modifying current processes for ICH E6 (R2) compliance
- Learn positive steps organizations have taken to adapt current practices to be compliant with the regulations
Who Should Participate:
- Clinical Operations/Clinical Development
- Clinical Quality Management/Clinical Quality Assurance
- Vendor Management/Alliance Management
- Clinical Outsourcing/Procurement
- Company Executives
- Clinical trial management
- Regulatory Affairs
- Inspection Coordination groups
|Cristin (Crissy) MacDonald, PhD
Executive Director, Client Delivery, The Avoca Group
As leader of the Avoca Group’s Integrated Consulting, Dr. Crissy MacDonald provides consulting to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has 12 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management. Her previous professional roles have touched every stage of the clinical trials process, from pre-clinical research through late-stage clinical development.
|Hershell W. Thompson
Senior Managing Consultant, Navitas Life Sciences
Hershell Thompson is Senior Managing Consultant with Navitas Life Sciences. In addition to recent project work on ICH E6 (R2) assessment and remediation, he has over 25 years of experience in clinical study management and monitoring, CRO oversight, inspection readiness, and change management.
|Dr. Janet Fernihough
Senior Consultant, Navitas Life Sciences
Janet Fernihough is a Senior Consultant with Navitas Life Sciences. In addition to recent project work on ICH E6 (R2) assessment and remediation, she has over 20 years of experience in drug Research & Development, Project Management, oncology immunotherapy trial design, and change management.
This Webinar is sponsored by the Avoca Quality Consortium™.