PTI - international

Course Description

A competent adverse drug reaction monitoring system is essential to ensure compliance when reporting drug safety data to FDA. Providing a step-by-step foundation for understanding the regulatory guidelines governing adverse events, the course begins by reviewing the fundamentals of adverse drug reactions. Participants will learn to formulate a systematic approach for reporting ADRs, which allows for analysis to help identify common trends. The course provides additional focus on implementing electronic submissions of adverse events. Techniques will be discussed for managing your MedDRA program and for validating your safety data system. Finally, crisis management strategies will be addressed. In addition to lecture, this course provides interactive exercises and group projects to strengthen your practices for managing effective and efficient adverse reporting systems and reports. Three interactive case studies focusing on hot topics including post-market safety surveillance and good  pharmacovigilance practices will be presented!