This webinar is intended for the pharmaceutical industry and associated service providers. It will provide pharmacovigilance and quality assurance departments with an overview of regulatory requirements and expectations for Good Pharmacovigilance Practice audit programs, with a focus on auditing activities internal to an organization as well as those contracted out to service providers and commercial partners, such as distributors and license partners.

Areas Covered in the Webinar:-

• European Guideline on Good Pharmacovigilance Practices: Modules I and IV
• Risk assessment of pharmacovigilance systems
• Scheduling of pharmacovigilance audits
• Conduct of pharmacovigilance audits – global departments, affiliates, service providers and commercial partners

Why Should You Attend:-

The introduction of Good Pharmacovigilance Practices in Europe emphasized the need for the pharmaceutical industry to have robust auditing of their pharmacovigilance systems across their audit universe, i.e. activities conducted by global departments, affiliates, service providers, distributors, etc. Subsequent inspections by European regulatory agencies had and continue to have frequent critical and major findings relating to audit practices, showing the need for the industry to continue to develop this area. This webinar will consider regulatory obligations and discuss the practical implementation of the audit lifecycle, from risk assessment to scheduling to conduct audits.

Module IV of the European Guideline on Good Pharmacovigilance Practices takes basic auditing principles and describes their application to the pharmacovigilance environment. Whilst the application legislation originates in Europe, the requirement is for a global audit program that considers all activities and all stakeholders resulting in a resource-intensive and complex activity. All pharmaceutical companies and service provides must ensure they have an audit program in place that meets agency expectations. The program should be risk-based, ensuring that areas of high risk are identified and targeted. Finally, the audit program should not only meet regulatory requirements but also help the organization in identifying areas of weakness and supporting the continued evolution of the pharmacovigilance system.

Who Will Benefit:-

• Quality assurance departments
• Pharmacovigilance departments
• Pharmacovigilance auditors