FORUM · Institut für Management GmbH
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69115 Heidelberg
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Course Risk based PV audits
PV audits & inspection
Day 1: Risk based PV audits
2019-09-12 2019-09-12 Ameron Hotel Königshof Adenauerallee 9 53111 Bonn +49 228 2601-0 +49 228 2601-529

PV audits & inspection strategies - Day 1: Risk based PV audits

Your guidance for a global risk-based GVP audit strategy

Our experts will help you to identify risks in your PV system and will provide you with helpful methods to adjust your audit processes and strategies.
  • PV risk identification
  • Methods for the evaluation of risk factors
  • Examine evolving global pharmacovigilance regulations and the impact on your audit strategy
  • Long term audit strategies

Aims and objectives

A risk based audit approach helps to identify the areas of highest risk to the organisation's Pharmacovigilance system, including its quality system for Pharmacovigilance activities. Moreover, it acknowledges the internal audit to provide assurance to the authorities that the risk management processes are managing risks effectively.

After attending the seminar you will be able to
  • prepare a strategic long term plan;
  • identify the PV activities and processes subject to PV audit; and
  • develop risk assessment criteria.

Who should attend
This seminar will be of benefit to all those working in the pharmaceutical industry who need to handle pharmacovigilance audits successfully.

Especially the following professionals are invited:
  • PV Quality Assurance Staff
  • PV Compliance professionals
  • Quality auditors
  • Pharmacovigilance Auditors
Your speakers
Mara Dinkel
PharmaLex GmbH, Friedrichsdorf, Germany

Anika Staack
EU-QPPV, Pharmacovigilance, UBC GmbH, Geneva, Switzerland

Go forward

Find out more on our international portfolio

Our international course portfolio

Are you interested in our international continuous education programme? We provide a variety of specialised courses for the healthcare industry.


More information on the seminar

Seminar bundle

We would also like to draw your attention to our seminar "Pharmacovigilance Inspection Readiness" which will take place on 13 September 2019.

When booking both seminars, the total fee is only € 1,690.00 (+ VAT).


More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2017 - 09.2018) produced a result of 1.6 (based on a school grading system of 1-6).