Key topics

• Regulatory Inspections – How can companies avoid critical and major findings?
• What GVP auditors currently focus on?
• Increase transparency and heighten operational standards to ensure accurate ADR detection
• Applying data analytics in Pharmacovigilance processes to increase the speed of signal detection
• Ensuring data integrity and Compliance with CGMP
• Good Pharmacovigilance Practices (GVP) Implementation
• Improving Signal surveillance
• Artificial Intelligence in Signal Detection
• Combination products – Regulation, trials, and risk management
• The role of data mining in Pharmacovigilance and its benefits
• IDMP standards and strategy
• Developing a pharmacovigilance risk management plan with a risk minimization action plan (RiskMAP) for high risk products
• Understanding how Artificial Intelligence is transforming pharmacovigilance
• Evaluation of quality and manufacturing in production
• Audits and Inspections
• Strengthening Pharmacovigilance quality management system
• Impact of AI in Pharmacovigilance
• Upcoming regulatory changes

Who should attend

CEOs / Presidents / MDs, CCOs/CMOs/CDOs, Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, and Managers specialising in:

• Assurance & Compliance
• Quality Assurance
• Quality Control
• Data Analysis
• Pharmacovigilance
• Pharmacology
• Pharmacoepidemiology
• Epidemiology
• Medical Information
• Health Outcomes
• PSUR/PBRER
• Clinical Data Management
• MedDRA
• PV Agreements
• PASS/PAES
• PSMF
• CAPA
• QPPV
• Medical Affairs
• Adverse Drug Reactions
• Drug/Product Safety
• Drug Development
• RMPs
• GPvP
• ICH-GCP
• Clinical Pharmacology
• Clinical Safety
• Clinical Trials
• Clinical Trial Management
• Clinical Development
• Clinical Research
• Risk Management
• Research & Development
• Patient Safety
• Signal Detection
• Signal Management
• Safety Surveillance
• Safety Databases
• Safety Evaluation
• Outcome Research
• Regulatory Affairs and Compliance
• Data management and data mining
• Benefit-Risk Assessment
• Regulatory Submissions
• PV Governance
• Safety Management
• Pharmacovigilance Operations
• PV Inspection and Audit Readiness
• Patient Support Programs
• Medical Safety
• Medical Product Safety Assessment
• Phase IV/Postmarketing Safety

Target audience

• International and regional health authorities and regulators
• Pharmaceutical, Vaccines, & Biotechnology companies
• Clinical Research Organization (CRO) service providers
• Business Process Outsourcing (BPO) service providers
• Risk Management Software developers
• Pharmacovigilance Audit Firm
• Pharmacovigilance consultancy service providers
• Contract Research Organisations
• Adverse Event/Case Management Service Providers
• Safety Database Providers for Case Management
• Healthcare/Pharmacovigilance Consultants
• Healthcare Translation Agencies
• Technology Vendors/Portal Service Providers