2024-04-20 2024-04-20 , online online, 1,190 € zzgl. MwSt. Angela Hartmann https://www.forum-institut.de/seminar/24042050-pharmacovigilance-inspection-readiness/referenten/24/24_04/24042050-course-pharmacovigilance-inspection-readiness_hartmann-angela.jpg Pharmacovigilance Inspection Readiness

Learn how to prepare your pharmacovigilance system in Germany, Europe and worldwide for an upcoming inspection in this one-day online course. Gain a comprehensive understanding of the EMA's Good Pharmacovigilance Practice (GVP/GPvP) modules, strategic and remote planning and preparation, and differences in GVP inspections around the world. Reserve your seat in our virtual seminar room.

Topics
  • Fundamentals: regulations, occurrence, types and aims
  • Strategic planning and preparation for a (remote) GVP inspection
  • Report, findings and follow-up measures
  • Dos and don'ts, and factors of success
  • Differences in inspection strategies between Europe and other areas in the world


Who should attend
This course will be conducted in English.

This online seminar will be of benefit to all those working in the pharmaceutical industry who need a deep understanding of the current global pharmacovigilance inspection strategy, with a focus on Germany, and how to successfully manage (remote) inspections.
Aims and objectives
To ensure that marketing authorisation holders comply with their pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specified intervals. This online course provides an insight into current (remote) pharmacovigilance inspection strategies.
    • After attending this online seminar you will be able to
      • plan and prepare for pharmacovigilance inspections according to the different requirements and
      improve how you deal with findings during and after the inspection.

      You are invited to join the moderated discussions on "Differences in inspection strategies between Europe and other parts of the world" and " pros and cons of remote inspections (authorities vs industry)".
      and interact directly with the speakers and other participants.
Your benefit

This seminar will enable you to prepare your pharmacovigilance inspections professionally and in accordance with legal requirements and best practices. Discuss your questions with experts from authorities and industry and find answers to your questions.

After the seminar you will understand the current pharmacovigilance inspection strategies and will be able to improve your processes in Germany, Europe, and worldwide accordingly.

Course Pharmacovigilance Inspection Readiness

Pharmacovigilance Inspection Readiness

Strategies for successful PV (remote) inspections in Germany, Europe and worldwide

Benefits
  • Be prepared for a global (remote) GVP inspection
  • Firsthand information from experts
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 24042050

Jetzt buchen

JETZT Buchen
Referenten

Angela Hartmann

Senior Expert Pharmacovigilance, Darmstadt

Per-Holger Sanden

Merck Healthcare KGaA, Darmstadt

Inspection Management Lead

Dr. Kimberley Sherwood

Senior Expert Pharmacovigilance, Bonn, Germany

Senior Expert Pharmacovigilance

Alles auf einen Blick

Termin

22/04/2024

22/04/2024

Zeitraum

09:00-17:30 CEST
You may dial in 30 min before the session

09:00-17:30 CEST
You may dial in 30 min before the session
Veranstaltungsort

online

online

Downloads
PROSPEKT
PROSPEKT
Gebühr

Veranstaltung - 1,190 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.

Veranstaltung - 1,190 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

Learn how to prepare your pharmacovigilance system in Germany, Europe and worldwide for an upcoming inspection in this one-day online course. Gain a comprehensive understanding of the EMA's Good Pharmacovigilance Practice (GVP/GPvP) modules, strategic and remote planning and preparation, and differences in GVP inspections around the world. Reserve your seat in our virtual seminar room.

Topics

  • Fundamentals: regulations, occurrence, types and aims
  • Strategic planning and preparation for a (remote) GVP inspection
  • Report, findings and follow-up measures
  • Dos and don'ts, and factors of success
  • Differences in inspection strategies between Europe and other areas in the world


Who should attend
This course will be conducted in English.

This online seminar will be of benefit to all those working in the pharmaceutical industry who need a deep understanding of the current global pharmacovigilance inspection strategy, with a focus on Germany, and how to successfully manage (remote) inspections.

Aims and objectives

To ensure that marketing authorisation holders comply with their pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specified intervals. This online course provides an insight into current (remote) pharmacovigilance inspection strategies.

    • After attending this online seminar you will be able to
      • plan and prepare for pharmacovigilance inspections according to the different requirements and
      improve how you deal with findings during and after the inspection.

      You are invited to join the moderated discussions on "Differences in inspection strategies between Europe and other parts of the world" and " pros and cons of remote inspections (authorities vs industry)".
      and interact directly with the speakers and other participants.

Your benefit

This seminar will enable you to prepare your pharmacovigilance inspections professionally and in accordance with legal requirements and best practices. Discuss your questions with experts from authorities and industry and find answers to your questions.

After the seminar you will understand the current pharmacovigilance inspection strategies and will be able to improve your processes in Germany, Europe, and worldwide accordingly.

Detailed programme

09:00-17:30 CEST
You may dial in 30 min before the session

08:45

Technical warm-up
You are welcome to log in a little earlier to test the audio and camera before the event begins.

09:00

FORUM Institut

Welcome and introduction

09:15

Dr Kimberley Sherwood

Pharmacovigilance 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
  • Strategies for GPvP inspection readiness: Long term and short term
  • Long term strategy: Quality management and inspection readiness plan
  • Short term strategy: Logistics, communication and training
  • Preparation of a GPvP inspection
  • Remote inspection
  • Post inspection activities
  • Sucess factors

10:45 Coffee break


11:00

Per-Holger Sanden

Continuation: Strategic planning and preparation of a GPvP inspection

11:45

Per-Holger Sanden, Angela Hartmann

How to prepare for inspection pitfalls

12:15 Lunch break


13:15

Dr Kimberley Sherwood

Pharmacovigilance inspections in Germany
  • Communication with the companies
  • Inspection plan and extent
  • Which are the most important documents?
  • Current developments: Inspection questionnaire and remote inspections
  • Frequent findings
  • Possible consequences for companies

14:15

Per-Holger Sanden, Angela Hartmann

Differences in inspection strategies between Europe and other areas in the world
  • PV Inspections in Europe
  • PV Inspections in America
  • PV Inspections in Africa and Arab countries
  • PV Inspections in APAC
  • Discussion round

15:45 Coffee break


16:00

Angela Hartmann

Inspection and follow-up
  • Main inspection phase
  • Communication strings: Intern and with the inspector
  • Post inspection activities: Report and CAPA Management

16:30

All speakers

Remote inspections - lecture and panel discussion

17:15

Q&A session

17:30 Seminar ends


Further information

Pre-meeting and technology check

Familiarise yourself with our Learning Space and gain the confidence you need by attending one of our free pre-meetings. No registration is required. You will find all the pre-meeting dates and the access information in your customer account. Pre-meeting meetings give you the opportunity to explore our Learning Space. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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Quality guaranteed!

Your feedback produced as result of 1.8 in 2022. Thank you!

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More on our quality criteria

Testimonials

All speakers provided excellent content and explanation of the content.

Very useful to get an overview of the procedure.


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.