EU General Data Protection Regulation (GDPR): Compliance for Drug development and Clinical Trials?
The General Data Protection Regulation (GDPR) is new legislation that had come into force on 25th of May 2018 brings substantial changes to the rules around personal data and its use. While it aims at building on existing Data Protection legislation, it represents a significant change for organisations that hold and process personal data particularly for clinical trial data and drug development.
Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
How to Write SOPs which are Compliant for Inspections for a GXP Compliance
This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.
Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials - are you Ready for Implementation for May 25th 2018?
Attain an understanding of the General Data Protection Regulation (GDPR).Be able to understand the key of the main tenets of GDPR which impact on clinical trials.
Speaker: Laura Brown | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials - are you Ready for Implementation for May 25th 2018?
Attain an understanding of the General Data Protection Regulation (GDPR).Be able to understand the key of the main tenets of GDPR which impact on clinical trials.
Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
How to Audit Against ICH GCP 2 Addendum to Ensure Compliance
It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. The new guideline includes a number of "hot" GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials. These new approaches are going to be areas inspectors will be focussing on.
Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details