; Online-Course Pharmacovigilance Inspection Readiness
2022-02-18 2022-02-18 , Online Online, 1.090,- € plus tax Per-Holger Sanden https://www.forum-institut.com/seminar/22022053-pv-audits-inspection-strategies-day-2-pharmacovigilance-inspection-readiness/referenten/22/22_02/22022053-online-course-pharmacovigilance-inspection-readiness_sanden-per-holger.jpg PV audits & inspection strategies - Day 2: Pharmacovigilance Inspection Readiness

Our online course will provide insights into the current (remote) pharmacovigilance inspection strategy in Europe. Learn all you need to know about the differences in the inspections and about the different requirements in this training. Save your place in our virtual seminar room.

Topics
  • Fundamentals: regulations, occurrence, types and aims
  • Strategic planning and preparation for a (remote) GPvP inspection
  • Report, findings and follow-up measures
  • Dos and don'ts, and factors of success
Aims and objectives
In order to ensure that marketing authorisation holders comply with pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specific intervals. Our workshop will provide insights into the current (remote) pharmacovigilance inspection strategies.

After attending the online-seminar you will:
  • be able to plan and prepare for pharmacovigilance inspections according to the different requirements and
  • improve how you process findings during and after the inspection.
Who should attend

This online seminar will be of benefit to all those working in the pharmaceutical industry who need a deep understanding of the current pharmacovigilance inspection strategy in Europe and how to handle (remote) inspections successfully.

Online-Course Pharmacovigilance Inspection Readiness

Pharmacovigilance Inspection Readiness

Benefits
  • Interactive online format
  • Firsthand information
  • Meet the experts!
  • We are following the IMI quality criteria

Webcode 22022053

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

18.02.2022

18.02.2022

Period

The times for breaks at online-semin...

The times for breaks at online-seminars are scheduled individually.
Venue

Online

Online

Fee
Ihr Ansprechpartner

Sonja Wittemann
Conference Manager

+49 6221 500-696
s.wittemann@forum-institut.de

Details

Our online course will provide insights into the current (remote) pharmacovigilance inspection strategy in Europe. Learn all you need to know about the differences in the inspections and about the different requirements in this training. Save your place in our virtual seminar room.

Topics
  • Fundamentals: regulations, occurrence, types and aims
  • Strategic planning and preparation for a (remote) GPvP inspection
  • Report, findings and follow-up measures
  • Dos and don'ts, and factors of success
Aims and objectives

In order to ensure that marketing authorisation holders comply with pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specific intervals. Our workshop will provide insights into the current (remote) pharmacovigilance inspection strategies.

After attending the online-seminar you will:

  • be able to plan and prepare for pharmacovigilance inspections according to the different requirements and
  • improve how you process findings during and after the inspection.

Who should attend

This online seminar will be of benefit to all those working in the pharmaceutical industry who need a deep understanding of the current pharmacovigilance inspection strategy in Europe and how to handle (remote) inspections successfully.

Detailed programme

The times for breaks at online-seminars are scheduled individually.

09:00

Introduction round and technical warm up

09:15

Dr Kimberley Sherwood

GPvP inspections - Fundamentals
  • Legal basis
  • Inspection objectives
  • Inspection types
  • Remote inspections - pros and cons

09:45

Per-Holger Sanden

Strategic planning and preparation of a GPvP Inspection
  • Planning and preparation for inspections (differences between face-to-face and remote inspections)
  • Guidance and quality documents
  • Inspection readiness plan
  • Importance of the PSMF

10:30 Coffee break


10:45

Per-Holger Sanden

Continuation: Strategic planning and preparation of a GPvP Inspection
  • Quality management related to inspections
  • Roles of various stakeholders
  • Importance & composition of the team
  • How to prepare for inspection pitfalls

12:00 Lunch break


13:00

Dr Kimberley Sherwood

Pharmacovigilance inspections in Germany
  • Communication with the companies
  • Inspection plan and extent
  • Which are the most important documents?
  • Current developements
  • Typical findings
  • Consequences for companies

14:00

Per-Holger Sanden, Heike von Treichel

Interactive discussion: Differences in inspection strategies between Europe and other areas in the world

15:00 Coffee break


15:15

Heike von Treichel

Inspection and follow-up
  • Communication with the inspector
  • The value of documentation and communication
  • Dos and don'ts, and factors of success
  • Report, findings and follow-up measures
  • Resolving inspection findings

16:45

Q&A Session

17:00 Seminar ends


Objectives

Objectives

  • Network with colleagues and meet regulators
  • Share experience and ideas in a neutral environment
  • Take away practial hints and tips
  • Excellent networking possibilities
  • This expertise will benefit your company

Booking options

Get ready for your next pharmacovigilance audit!

A risk based audit approach helps to identify the areas of highest risk to the organisation‘s Pharmacovigilance system, including its quality system. Moreover, it acknowledges the internal audit to provide assurance to the authorities that the risk management processes are managing risks effectively. Our workshop on day 1 will provide insights into the current pharmacovigilance audit strategies.

Please find further information with the webcode 2202202.

This distinguishes our events

Overall impression: 100% of the participants’ feedback was very good or good. (October 2018)

Course content: 100% of the participants’ feedback was very good or good. (October 2018)

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Seminar bundle

We would also like to draw your attention to our seminar "Risk based PV audits" (on 17 February).

Details
Seminar bundle
Testimonials

Hear from our past delegates and sponsors and learn more about the events.

Details
Testimonials
Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. Thank you!

Details
More on our quality criteria

Testimonials


Good & clear training in pharmacovigilance inspection readiness. Clear and very good speakers.

Bita Mangin

Sanofi Aventis Groupe, Paris


Practical examples related to PV inspection requests.


Sharing of examples from recent experiences.


Possibility to hear from other companies about their inspection experiences.