Online Pharmacovigilance Training

Pharmacovigilance Online Training Modules

Drug Safety and Pharmacovigilance

This foundational course bundle discusses the phases of pharmacovigilance during a drug’s life cycle, the collection of adverse event data, the assessment of cases, and commonly used terms in the pharmacovigilance process. Also covered are the different types of pharmacovigilance regulatory reports, their submission timeframes, and reporting formats. The intended audience for these courses is healthcare professionals, pharmaceutical industry professionals.

• Drug Safety and Pharmacovigilance: Assessing
• Drug Safety and Pharmacovigilance: Reporting

Pharmacovigilance: Global Requirements

This detailed regulatory course bundle provides basic global laws, regulations, and guidance for drug safety and pharmacovigilance as well as the components of effective and compliant pharmacovigilance systems, including good pharmacovigilance practices, in the EU. The intended audience for these courses is healthcare professionals, pharmaceutical industry professionals, regulatory authority personnel, clinical researchers, academic scholars, and risk management specialists.

• Pharmacovigilance: Global Requirements: Systems
• Pharmacovigilance: Global Requirements

Pharmacovigilance Assessing Data

This comprehensive course bundle will elevate your knowledge of the purpose and process of signal management for pharmaceutical manufacturers as well as increase your understanding of data mining and risk management as methods of pharmacovigilance for marketing authorization holders (MAHS). The intended audience for these courses is healthcare professionals, pharmaceutical industry professionals, regulatory authority personnel, clinical researchers, academic scholars, and risk management specialists.

• Assessing Data: Pharmacovigilance Signaling
• Assessing Data: Data Mining and Risk Management

Pharmacovigilance Audit and Inspection

Pharmacovigilance audits and inspections are essential for patient safety and public health. This course bundle covers the elements of audits and inspections as and provides information to aid pharmaceutical and biologic companies operating in the US and EU in preventing common problems that are found during regulatory inspections for drug safety and pharmacovigilance. The intended audience for these courses is pharmaceutical manufacturers and Marketing Authorization Holders.

• Pharmacovigilance Audit and Inspection: Preparation
• Pharmacovigilance Audit and Inspection: Dos and Don’ts

Device Safety and Vigilance

This course bundle discusses the collection of device adverse event data and assessment of cases in the medical device vigilance process, as well as regulatory vigilance reports of adverse device events for regions. The intended audience for these courses is medical device manufacturers and Marketing Authorization Holders. Included Course Modules Device Safety and Vigilance: Assessing Device Safety and Vigilance: Reporting.

• Device Safety and Vigilance: Assessing
• Device Safety and Vigilance: Reporting