The 3-Hour Virtual Seminar on Safety Audits and Pharmacovigilance (PV) Inspections 2019 covers topics such as:
- Recognize post-marketing PV expectations and compliance on a global level
- Review the EMA PV Modules at the basic level
- Determine PV reporting responsibilities applicable to global PV submissions
- Understand the FDA and EMEA’s requirements for a risk based audit program and current interpretation
- Identify the PV activities and processes subject to PV audit
- Plan, develop and implement the PV Audit Strategy Plan
- Identify the PV audit scope and entities subject to PV audit
- Develop risk assessment criteria
- Perform risk assessments
- Categorize the entities subject to PV audit
- Apply basic auditing concepts to assess PV compliance
- Prioritize entities for audit according to relative risk
The 3-Hour Virtual Seminar on Safety Audits and Pharmacovigilance (PV) Inspections 2019 brings together:
- PV Compliance professionals
- PV Quality Assurance Staff
- Pharmacovigilance Auditors
- Quality auditors
- PV Service Provider Relationship Managers
- Relevant Pharmacovigilance Staff
- Heads of Pharmacovigilance Quality Assurance Departments
- MAH Affiliates responsible for Pharmacovigilance
- Drug Safety Staff
- Auditors transitioning into pharmacovigilance auditing
- Safety Physicians
- Medical Information Staff
