June 11, 2014
FoREMS & More: ICH Q-10 and Continuous Learning and Adaptive Systems for Risk Management
ICH Q-10 and Continuous Learning and Adaptive Systems for Risk Management
Wednesday, June 11, 2014
12 pm New York time, 9 am California time, 5 pm London time
In the years since the issuance of draft guidance for Risk Evaluation and Mitigation Strategies (REMS) by the FDA and the guideline on good pharmacovigilance practices (GVP) by the EMA, many pharmaceutical companies have established organizations, staff capabilities, and operating processes for planning risk management systems for drug safety. At this point of organizational development, the focus needs to shift to establishing continuous learning and adaptive systems (CLAS) to keep pace with evolving regulatory expectations and technological advances. Likewise, CLAS offers a process for continuous improvement by risk management professionals who are building Quality by Design (QbD) into clinical studies. This webinar uses ICH Q-10 as the framework for implementing CLAS.
Webinar highlights include:
- An assessment of the status of implementation of risk management systems, including accomplishments and gaps
- An overview of ICH Q-10 and the key principles of continuous learning and adaptive systems
- Examples of implementing CLAS in drug safety and clinical development
- Stephen Sun, MD, MPH, Chief Medical Officer, ParagonRx
- Jeff Fetterman, President, ParagonRx
To view the replay of this webinar, click here.
To view the slides presented during this webinar, click here.
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