The PSMF- Accountability, Inspection Preparation and Business Analytics

This webinar will discuss the structure of the PSMF as per EU Directive 2010/84/EU and how adopting this document in the US will provide a transparent process for Accountability, Inspection Preparation and Business Analytics.

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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)
Instructor Profile:
Christine Wittrock 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.

Refund Policy

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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