DRUG SAFETY and PHARMACOVIGILANCE
- Development
- Safety considerations early in drug development
- Pre-market considerations
- Post-market considerations
- Adverse Event Reporting
- Protocol specified requirements
- Specifications for Adverse Events (AE), Serious Adverse Events (SAE), and Adverse Events of Interest (AESI)
- Data capture, CDISC data standard
- Safety case assessments
- Expedited reporting systems; from site to sponsor to regulatory authority
- Safety Monitoring
- Safety review
- Risk-based monitoring
- Data and Safety Monitoring Boards, Data Monitoring Committees
- Pharmacovigilance
- Data Mining
- Signal detection, Signal refinement
- Risk benefit evaluations
- Risk mitigation strategies
- Training
- Comprehensive training package: from study launch to study conduct. Includes human subjects protection, safety data capture and reporting, submission of interpretable, high quality safety reports
- Curriculum: modular, interactive
- Audience: all levels of clinical personnel responsible for safety
- Customization: e.g. for specific study protocols, or workshops for general safety professionals
DRUG DEVELOPMENT Regulatory science
- RX to OTC Switch
- OTC Monograph
- Actual Use Trials
- Label Comprehension Studies
- Safety & Pharmacovigilance
- Cosmetics
- Devices
- GCP
CLINICAL TRIAL RESEARCH
- Strategic development of the clinical research portfolio
- Protocol development
- Clinical trial operations
- Risk-based monitoring
- NIH application and peer review
- Training:
- Investigators: protocol development, NIH peer review, safety assessments
- Reviewers: safety review
- Clinical site staff: human subjects protection, safety monitoring, safety reporting
- Safety Workshops for clinical personnel in Chinese hospitals, universities, pharmaceutical industry
ADVERSE EVENT DATA STANDARDS DEVELOPMENT
- SAE Supplement to the CDISC CDASH standard for the AE Domain published 2013. Purpose is to facilitate the capture of safety data and the reporting of SUSARs to global regulatory authorities. The CDASH standard is consistent with requirements for the ICSR and the E2B message.
- Training:
- Data managers, safety professionals, statisticians: an integrated approach to understanding drug safety & pharmacovigilance regulatory environment, and standards for capturing and reporting adverse events