PV audits & inspection strategies - Day 1: Risk based PV audits
Your guidance for a global risk-based GVP audit strategy
- 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 objectivesA 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.
Especially the following professionals are invited:
- PV Quality Assurance Staff
- PV Compliance professionals
- Quality auditors
- Pharmacovigilance Auditors
10:00 Coffee break
- Where errors can occur
- Where are errors associated with dangers? What damage is associated with the error?
- What is the probability of occurrence?
- Product specific risks
- Organisational risks
- How to set priorities - Prioritisation factors
- Points to consider
- Calculation of budget and manpower
- Monitoring of the global audit programme
- How to deal with deviations
15:30 Coffee break
- PV risks
- An annual audit plan
- A long term audit strategy
17:00 End of the seminar
Senior Manager Pharmacovigilance, Head of Pharmacovigilance Team (Frankfurt)
Nähere Informationen finden Sie hier.
Anika Staack serves as EU-QPPV and local QPPV. In this role, she is responsible for establishing and maintaining of pharmacovigilance systems as well as ensuring compliance and meeting quality standards of PV operations. She acts as contact point for regulatory authorities in regards to PV and also for PV inspections. Anika has held positions of increasing responsibility for the past 15 years in the pharmaceutical industry, with extensive experience in the clinical research operations sector. Anika holds a Master of Science degree in biology from Marburg University.
Phone: +49 228 2601-0
Fax: +49 228 2601-529
- 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
Our course will provide insights into the current 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.
13.09.2019 in Bonn
This course will give you an in-depth knowledge on the CMC requirements for the marketing authorisation.
25. - 26.09.2019 in Amsterdam
Reformulation, repurposing, repositioning - in this course you will learn about the options and possible hurdles to overcome in the development and market access of your drug.
04.09.2019 in München
A course to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chile and Brazil with local experts from Brazil and Spain.
23. - 24.09.2019 in Frankfurt-Raunheim
Tips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.
21.10.2019 in Frankfurt