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 programmes, with a focus on auditing of activities internal to an organisation as well as those contracted out to service providers and commercial partners, such as distributors and licence partners.
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 practical implementation of the audit lifecycle, from risk assessment to scheduling to conduct of audits.
Module IV of 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 programme 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 programme in place that meets agency expectations. The programme should be risk-based, ensuring that areas of high risk are identified and targeted. Finally, the audit programme should not only meet regulatory requirements, but also help the organisation in identifying areas of weakness and supporting the continued evolution of the pharmacovigilance system.
Areas Covered in the Webinar:
Miranda DollenIndependent Pharmacovigilance Consultant, MZD Consulting
Miranda Dollen has over 25 years’ experience in pharmacovigilance. She began her career at the UK regulatory agency in the pharmacovigilance business unit, before spending 7 years in the UK pharmaceutical industry. In 2004 Miranda moved to the service provider side of the business, spending 14 years at CanReg, acquired by Optum, acquired by Mapi and latterly acquired by ICON. During that time she worked with multiple organisations as a European Qualified Person for Pharmacovigilance, led the European team and spent the last 4 years of her time with ICON as Vice President, Pharmacovigilance, responsible for global pharmacovigilance activities. Since 2018 Miranda has provided independent consultancy services to the pharmaceutical industry. During her career Miranda has worked with multiple Quality Assurance departments to develop and maintain a pharmacovigilance audit programme, as well as personally conducting pharmacovigilance audits.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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