Why Should You Attend:
The Pharmacovigilance System Master File (PSMF) is a legal requirement in the European Union (EU) and in several countries outside the EEA. Although a PSMF is not required for products approved and marketed only in the US or in areas of the world which do not require this document, we see clear advantages to adopting this document. This webinar discusses those advantages, the structure and content of the PSMF, and the corporate culture that’s required for its adoption and effective use.
Health Authorities are looking aggressively at corporate oversight of PV processes and systems as a way to ensure public safety. FDA warning letters stress the critical responsibility to establish, monitor and report on the effectiveness of quality programs. A PSMF provides an organized approach to PV oversight of regulatory compliance, inspection preparation, CAPA management and effectiveness, and business analytics and demonstrates corporate accountability to public safety.
By attending this webinar, you will learn which systems are monitored, who is responsible for providing those updates, how to update the document, and how to use this document as a business analytic and inspection preparation tool. You will understand the clear advantage to the PSMF and how to best present this process to your leadership teams.
Areas Covered in the Webinar:
Who Will Benefit:
This course will be relevant for anyone needing a comprehensive overview of the Pharmacovigilance (PV) function and duties. This includes persons providing updates in the PSMF Annexes.
Christine Wittrock, Owner of Wittrock Consulting LLC, has 30 years’ experience in the life sciences. Christine’s most recent contributions to the pharmaceutical industry include Safety Governance, EU-QPPV Office Support (PSMF updates, PV QMS, Audits, Inspections, CAPA writing/implementation and effectiveness monitoring). Christine has also served as a faculty instructor in the Temple University RAQA Program for over nine years, educating hundreds of industry stakeholders in Clinical Trial Drug Safety, PV Operations, Bioethics and Drug Development. She has extensive knowledge in global drug regulation (ICH, EU, and FDA) for drugs and biologics and she has a comprehensive understanding of pharmaceutical life cycle management (GXPs). Christine’s greatest strengths are her pragmatic, organized approach to explaining complex drug regulations, her ability to see the big picture, and advising on strategies.
Christine is also committed to preserving the dignity, human rights and welfare of the marginalized and politically oppressed. She serves as a Housing Director for the Phoenixville Area Refugee Initiative and on the Planning Committee for the Phoenixville Women’s Outreach.
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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. ComplianceOnline 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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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