Overview
This course provides an in-depth look at practical solutions to post-marketing safety and 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 pharmaceutical safety and pharmacovigilance
- Privacy, information technology, and data protection issues involved in pharmaceutical safety
- How to speak the language of pharmaceutical safety, signaling, risk management, and pharmacovigilance
- The future of pharmaceutical safety and pharmacovigilance
- The basics of pharmaceutical safety inspection
Who Should Attend
Professionals involved in:
- Global drug safety, pharmacovigilance, and risk management
- Regulatory and legal affairs
- CROs, start-ups, small companies, and generic pharmaceutical companies
- Training and teaching of pharmaceutical safety and pharmacovigilance
- Clinical health care
- New pharmaceutical development
- Outsourcing and offshoring of pharmaceutical safety
- Supervising and dealing with pharmaceutical safety
Learning Objectives
Participants who complete this course should be able to:
- Identify the legal and regulatory basis of postmarketing drug safety and pharmacovigilance
- Describe how your drug safety system will perform on an audit or governmental inspection
- Explain the requirements, changes, pitfalls, and risks of drug safety and pharmacovigilance, applying the knowledge gained in your daily pharmacovigilance functions
- Discuss US, EU, and other countries handling of expedited reports, ICSRs, aggregate reports, safety labeling, risk management, causality determination, signaling, audits and inspections, quality, compliance, IT, basic epidemiology, and more
- Describe your company’s drug safety systems and determine whether they are meeting the needs and requirements
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.