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Clinical Safety and Pharmacovigilance Training Week |
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Clinical Safety and Pharmacovigilance Training Week
November 15-19
Horsham, PA
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| Register for two or more courses and receive a 15% discount on your total registration! |
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November 15-16
Premarketing Clinical Safety & Pharmacovigilance
Learn how to comply with FDA and European regulations for clinical safety.
What you will learn
- Fundamental concepts of drug safety and pharmacovigilance and their application to clinical development
- How to comply with FDA and European regulations for clinical safety
- How to pass a preapproval safety inspection
- Proven concepts of premarketing risk assessment and its important role in the development of Risk Evaluation and Mitigation Strategies (REMS)
- How to effectively use signaling tools and techniques to support premarketing risk assessment
November 17-18
Postmarketing Drug Safety & Pharmacovigilance
Learn the key tools available for pharmacovigilance, discuss their uses, and consider the future directions of the field.
What you will learn
- How to make your pharmacovigilance program more efficient and compliant
- US, European, and other global requirements and standards in drug safety and pharmacovigilance
- Privacy, information technology, and data protection issues involved in drug safety
- How to speak the language of drug safety, signaling, risk management, and pharmacovigilance
- The future of drug safety and pharmacovigilance
- The basics of drug safety inspection
November 19
Introduction to Signal Detection and Data Mining
This course will provide techniques for uncovering potential drug safety signals, as well as expert instruction on the role of data mining in signal detection.
WHAT YOU WILL LEARN
- Why signal detection is needed
- Regulatory requirements
- Approaches to signal detection
- Good pharmacovigilance practices
- Data mining fundamentals
- How to use the Bayesian Confidence Propagation Neural Network (BCPNN)
- Review formulae for determining Proportional Reporting Ratio (PRR) and Multi-item Gamma Poisson Shrinker (MGPS)
CONTACT
For more information and to register, contact Laura Parker at 215.442.6101 or Laura.Parker@diahome.org. |
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