2023/6/15 (Thur)【Drug Safety Series】Key PV inspection findings -The difference between US vs UK/EU

<開放報名中> 2023/6/15 (Thur)【Drug Safety Series】Key PV inspection findings -The difference between US vs UK/EU

<開放報名中> 2023/6/15 (Thur)【Drug Safety Series】Key PV inspection findings -The difference between US vs UK/EU

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About Course

Organizer：Taiwan Salt and Light Institute
Location：Microsoft Teams Live Webinar

【Due to intellectual property rights constraints, we are unable to provide the video recording.】

Date：2023/6/15 (Thur) 14:30-17:30 (GMT+8)
Speaker：Anika Staack, EU-Qualified Person for Pharmacovigilance (EU-QPPV)

【Target Audience】
(1) Anyone who is interested in PV in US, UK and EU
(2) Anyone who has experience in working in drug safety

Course Outline

✨The live webinar will be conducted in English.✨

1. Real Example of an EU PV Inspection

  • Presenting a real EU PV inspection setting
  • Introducing a real standard question
  • Presenting a real critical PV finding

2. EU PV Inspection Procedure

  • Which EU authority will come to you?
  • EU inspectors approach
  • EU inspectors focus and conduct
  • EU inspection report & key PV findings
  • How to deal with findings
  • Impact

3. ISO 9001:2015 Principles about Quality Management Systems – Auditing Standards

  • ISO 9001:2015 Principles about Quality Management Systems
  • International standards adopted for inspections
  • Basis of each inspection: Documents and Processes
  • Basis of each inspection: the Interview
  • Why is a Quality Management System mandatory?
  • Explanation of Good Documentation Practice
  • Explanation of document life-cycle

4. Key PV Inspection Findings in the UK

  • UK inspectors approach & conduct
  • UK key PV findings

5. Key PV Inspection Findings in the USA

  • FDA inspectors approach & conduct
  • US key PV findings
  • FDA inspection report
  • How to deal with warning letters and findings

6. Comparison of Different PV Inspection Findings between the EU and the USA

  • Comparison between rating approach
  • Comparison between main areas
  • Comparison between findings per area

7. Q&A Session

Course Fees & Registration Link

Course Fees：Special Price $4,800 NTD/person; Group Registration Price $4500 NTD/person for two or more participants

✨Certificate of Attendance will be issued only if participants complete 3 hours of the webinar and will be sent to your email along with the invoice within two weeks after the webinar. ✨
Click here to register

Speaker CV

Anika Staack

Anika Staack

Current Position：

  • EU-Qualified Person for Pharmacovigilance (EU-QPPV)
  • Local German QPPV Consultant and Speaker

Previous Experience：

  • EU-QPPV / Stufenplanbeauftragte & Group Leader PV at Medice
  • Senior Drug Safety Manager at ICON
  • Lead Site Management Associate at PRA
  • Clinical Research Associate at SKM Oncology

View More…

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