Risk-based Monitoring Webinars

Risk-based Monitoring Webinars2016-06-12T11:17:56+00:00
@RACT Pro was designed specifically for CRO, Pharma, Biotech and Medtech enterprises transiting to risk-controlled strategies and processes to meet ICH E6 (R2) compliance.

- What levels of risks exist?
- Why @RACT covers study-level ones?
- Features of @RACT
- Improvements of risk-assessment questions
- How to remain objective by assessing risks?
- Tips and tricks by using @RACT
- Risk identification module  (with automated and self-learning suggestions library)
- Risk assessment module
- Risk mitigations module (with automated and self-learning suggestions library)
- Various risk-assessment questionnaire catalogs (TransCelerate RACT, Cyntegrity RACTs, etc.)
- Versioning of risk assessment changes with audit trail
- Downloadable Excel reports
This webinar will take place on 11th Dec 2018 at 04:00 pm.
Details
Cyntegrity's webinar guest - Dr. Nurcan Coskun (Global RBM Manager at Medtronic) will present about challenges of RBM implementation in the medical device industry.

Dr. Nurcan has 20 years of clinical research experience with contributing in roles such as Clinical Research Manager, Global Clinical Operations Oncology Group Leader, Project Leader, Clinical Monitoring Manager and recently as Global Risk-Based Monitoring and Technology Solutions Manager at Medtronic.

The main topics of the webinar:

- Differences of Medical Devices studies
- RBM Implementation strategy
- Challenges and lessons learned
- Change management for large-scale deployment
- Cloud systems support of RBM in MD studies
- Next generation - Risk-based Quality Management
This webinar will take place on 18th Dec 2018 at 04:00 pm.
Details

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