The PSMF- Accountability, Inspection Preparation and Business Analytics

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.

• How do you demonstrate corporate accountability for public safety?
• Does your leadership struggle to understand pharmacovigilance (PV), the scope of PV across the company and the implications for noncompliance?
• Do you struggle preparing for PV inspections (working with global offices, identifying the right people to answer questions (SMEs), locating documentation)?
• Do you have an adequate and effective PV quality system for monitoring the medicines you market, license, or co-license?
• How do you track and communicate the status of PV agreements, licensing agreements, mergers, acquisitions and organizational changes?
• How do you communicate the results of audits and inspections; track and monitor the status and effectiveness of CAPAs?
• Have you established business analytics (KPI) for PV Critical Processes?
• Do you monitor these KPI and provide routine reports to your Chief Scientific Officer?

Areas Covered in the Webinar:

• Understanding the regulatory requirements for PSMF
• Role of the QPPV
• What are the reference documents?
• What systems are affected?
• What is the process for producing, updating and maintaining a PSMF?
• Who is responsible for providing updates to the PSMF?
• How do we version control the PSMF?
• Using the PSMF as a tool for business analytics and to prepare for PV Inspections
• What are the challenges to implementing a PSMF in the US?

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.

• CEOs accountable for oversight along with the Qualified Person for PV (QPPV)
• EU-QPPV staff responsible for PV agreements and PSMF updates
• Quality Assurance personnel (Audits and Inspections, CAPA Management)
• Quality (Manufacturing, Product Technical Complaints, Recalls, Counterfeits)
• Medical Literature Monitors (ADR collection and reconciliation)
• PV Scientists (Safety data collection, ICSR case management, reporting)
• PV Physicians (Signal Management, REMS, RMP/PV Plan, PBRER/PADER)
• PV Database staff (Computerized systems and databases)
• PV QMS staff [PV System performance, business analytics (KPI)]
• Clinical Research and Development Staff (Clinical Trials, DSUR, PASS, PMR/PMC)
• Regulatory Affairs (CCDS/CCSI and local label updates; Health Authority Communication)
• Medical Communications (AE reports, Product Technical Complaint Reports)
• Commercial Development, Commercial Operations (Sales and Distribution)
• Clinical Research Organizations
• Vendor Management Personnel
• Finance
• Legal (Partnerships and License Agreements)

Christine Wittrock
Owner, Wittrock Consulting LLC

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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