• Personnel and staff in industries connected to development and marketing of pharmaceuticals and medical devices, especially those who wish to receive additional training to advance or switch careers.
• Graduate, medical, and post-baccalaureate students who want to seek employment in this new growing sector and medical personnel who may be impacted by the growth of this science.
• Individuals who currently work in epidemiology, biotech, life science, and pharmaceutical industries.
• Medical staff (residents, interns, nurses) who wish to pursue an alternative career related to pharmaceutics

By the time participants complete the course, they should be able to:

• Describe the methods and strategies used to identify and develop drugs
• Describe the regulatory environment as it pertains to pharmacovigilance and pharmacoepidemiology
• Define the steps of the clinical trial process
• Define the elements of patient safety and concepts of benefit-risk, signal management, product safety vaccine and post-marketing drug safety
• Articulate the elements of pharmacovigilance based on FDA good pharmacovigilance practices
• Apply the concepts in Pharmacovigilance to address specific challenges presented by special populations

The Regulatory Environment

• Does Regulation Drive Science or Does Science Drive Regulation?

Safety Data and Real World Evidence

• Product Safety Monitoring in Clinical Trials
• Signal Management and Methods of Signal Detection
• Safety Governance
• Causality Assessments - Liver, Renal, Skin and Major Adverse Cardiac Events 

Epidemiology Real World Evidence

• Role of Epidemiology in the Pharmaceutical Industry
• Real World Epidemiological Studies 

Special Topics

• Pharmacovigilance in Pregnancy
• Pharmacovigilance in Pediatrics
• Pharmacovigilance in Elderly

Special Populations

• Monitoring Safety of Vaccines
• Medical Devices Vigilance and Post Market Surveillance
• Applications of Human Factors and Health Literacy in Pharmacovigilance

The Next Frontier

• Risk Management
• Benefit-Risk
• Information Technology in Pharmacovigilance: Current State and Future Direction
• The Future of Safety Science is Happening Now