Clinical Quality & Compliance Masterclass

This focused two-day masterclass offers a unique opportunity to hear about the impact of globalization, outsourcing and the increasing complexity of clinical trials on the international quality standards for clinical trials. Delegates will gain first-hand experience on increasing clinical quality performance through effective communication, cooperation & training. Attendees will work together with their industry peers and will build an Action Plan for ensuring that clinical sites and vendors are inspection ready.

Key takeaways:
- Get deeper insights from MedImmune into the expectations for risk management and IT systems according to the amended GCP guideline ICH E6
- Explore with Amgen new approaches to auditing investigator sites where a risk based monitoring model is applied
- Practical tips from a GCP inspector
- Reveal the strategies from Pfizer and Bristol Myers Squibb, how they ensure the sponsor accountabilities in the quality oversight in an outsourced model
- Gain first-hand experience from Boehringer Ingelheim, how they create an effective CAPA plan and prepare your own CAPA plan in the workshop
- Learn from UCB, how they utilize the data analytics in the context of risk-based auditing, risk-based monitoring and fraud detection
- Get an understanding on how to best prepare for a sponsor health authority inspection from the workshop facilitated by Actelion