2023-11-28 2023-11-28 , 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

Discover the cutting-edge landscape of (remote) pharmacovigilance inspection strategy in Europe through our dynamic online course. Acquire comprehensive knowledge about Good Pharmacovigilance Practice (GPvP), differences in GPvP inspections and about the wide spectrum of requirements across various countries. 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
  • Differences in inspection strategies between Europe and other areas in the world


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.
Aims and objectives
In order to ensure that marketing authorisation holders comply with pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specific intervals. This online course will provide insights into the current (remote) pharmacovigilance inspection strategies. In addition, the pros and cons of remote inspections from the different perspectives (authorities vs. industry) will be discussed.

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.
You are cordially invited to participate in the moderated discussion round on the topic "Differences in inspection strategies between Europe and other areas in the world" and to enter into direct exchange with the speakers and the other participants.
Your benefit

This seminar enables you to professionally prepare your pharmacovigilance inspections in accordance with the applicable requirements.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 accordingly.

Course Pharmacovigilance Inspection Readiness

Pharmacovigilance Inspection Readiness

Strategies for successful PV (Remote-) Inspections in Europe

Benefits
  • Be prepared for a (remote) GPvP inspection
  • Firsthand information from experts
  • We are following the IMI quality criteria

Webcode 24042050

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

22/04/2024

22/04/2024

Zeitraum

09:00-17:30 You may dial in 30 min. ...

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

online

online

Gebühr
Your contact

Nadja Wolff
Conference Manager

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

Details

Discover the cutting-edge landscape of (remote) pharmacovigilance inspection strategy in Europe through our dynamic online course. Acquire comprehensive knowledge about Good Pharmacovigilance Practice (GPvP), differences in GPvP inspections and about the wide spectrum of requirements across various countries. 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
  • Differences in inspection strategies between Europe and other areas in the world


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.

Aims and objectives

In order to ensure that marketing authorisation holders comply with pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specific intervals. This online course will provide insights into the current (remote) pharmacovigilance inspection strategies. In addition, the pros and cons of remote inspections from the different perspectives (authorities vs. industry) will be discussed.

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.
You are cordially invited to participate in the moderated discussion round on the topic "Differences in inspection strategies between Europe and other areas in the world" and to enter into direct exchange with the speakers and the other participants.

Your benefit

This seminar enables you to professionally prepare your pharmacovigilance inspections in accordance with the applicable requirements.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 accordingly.

Detailed programme

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

09:00

Introduction round and technical warm up

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 & 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 & 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 & Arabic 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.