2024-07-03 2024-07-03 , online online, 1,890 € zzgl. MwSt. Anika Staack https://forum-institut.de/seminar/24102053-the-gvp-refresher/referenten/24/24_10/24102053-course-gvp-refresher_staack-anika.jpg The GVP Refresher

The Good Pharmacovigilance Practices modules (GVP modules) by the European Medicines Agency (EMA) serve as a reference for standard practices in pharmacovigilance. This online course serves as a refresher and ensures that you are up to date with the best practices.

Topics
  • GVP modules I-XVI and annexes
  • Pharmacovigilance system master file (PSMF)
  • Monitoring, recording and evaluating drug adverse effects
  • Quality and risk management
  • Audits and inspections


Who should attend
This online course is designed for professionals in the pharmaceutical industry needing reliable continuing training or a refresher course in pharmacovigilance. It covers all GVP modules, is highly practical and is primarily intended for PV Managers and experienced personnel at the PV interface.

Basic knowledge and/or practical experience in pharmacovigilance are prerequisites.
Aims and objectives
The Good Pharmacovigilance Practices modules (GVP modules), published and regularly updated by the European Medicines Agency (EMA), compile standard practices and measures to facilitate the execution of pharmacovigilance duties, serving as a key reference in European drug safety.

Update your knowledge of GVP in this course and apply what you learn directly in the practical workshops. A broad range of topics, from general pharmacovigilance systems to important documents like the PSMF and PSURs, as well as quality and risk management, await you.
Your benefit

This online course will

  • provide a comprehensive overview of all GVP modules.
  • enable you to record, collect and evaluate drug adverse effects.
  • help you understand the structure and content of the PSMF, PSURs and PASS.
  • enable you to implement risk management methods effectively.
  • provide practical experience through the included workshops and adequately prepare you for your next audit or inspection.

Course GVP Refresher

The GVP Refresher

Old and New in the Good Pharmacovigilance Practices

Benefits
  • Comprehensive pharmacovigilance training
  • All modules in two days
  • Sustained learning through interactive workshops
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 24102053

Jetzt buchen

JETZT Buchen
Referenten

Anika Staack

ARC-Traicoa UG, Überlingen, GERMANY

Freelancer, EU-QPPV and local QPPV; 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.

Dr. Stefan Zohmann

Drehm Pharma GmbH, Wien, AUSTRIA

Joint Owner and CEO
More information please click here.

Dr. Eva Bauer

DREHM Pharma GmbH, Vienna, AUSTRIA

Head of Medical Writing and Medical Affairs After studying biomedicine and biotechnology, Eva Bauer initially spent several years in research. During her PhD studies, her passion for writing deepened, which is why she has now been working as a medical writer and medical affairs manager for the Austrian consultancy DREHM Pharma GmbH for over 8 years. She is now head of the associated department and has not only accompanied numerous vigilance writing projects in her past, but has also spent several months as case manager.

Alles auf einen Blick

Termin

07-08/10/2024

07-08/10/2024

Zeitraum

Both days: 09:00-17:00
You can dial in 30 min before the course starts

Both days: 09:00-17:00
You can dial in 30 min before the course starts
Veranstaltungsort

online

online

Downloads
Gebühr

Veranstaltung - 1,890 € zzgl. MwSt.
The fee includes high-quality course materials (also available for download), a certificate of participation, access to our Learning Space and technical support, including a test meeting.

Veranstaltung - 1,890 € zzgl. MwSt.
The fee includes high-quality course materials (also available for download), a certificate of participation, access to our Learning Space and 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

The Good Pharmacovigilance Practices modules (GVP modules) by the European Medicines Agency (EMA) serve as a reference for standard practices in pharmacovigilance. This online course serves as a refresher and ensures that you are up to date with the best practices.

Topics

  • GVP modules I-XVI and annexes
  • Pharmacovigilance system master file (PSMF)
  • Monitoring, recording and evaluating drug adverse effects
  • Quality and risk management
  • Audits and inspections


Who should attend
This online course is designed for professionals in the pharmaceutical industry needing reliable continuing training or a refresher course in pharmacovigilance. It covers all GVP modules, is highly practical and is primarily intended for PV Managers and experienced personnel at the PV interface.

Basic knowledge and/or practical experience in pharmacovigilance are prerequisites.

Aims and objectives

The Good Pharmacovigilance Practices modules (GVP modules), published and regularly updated by the European Medicines Agency (EMA), compile standard practices and measures to facilitate the execution of pharmacovigilance duties, serving as a key reference in European drug safety.

Update your knowledge of GVP in this course and apply what you learn directly in the practical workshops. A broad range of topics, from general pharmacovigilance systems to important documents like the PSMF and PSURs, as well as quality and risk management, await you.

Your benefit

This online course will

  • provide a comprehensive overview of all GVP modules.
  • enable you to record, collect and evaluate drug adverse effects.
  • help you understand the structure and content of the PSMF, PSURs and PASS.
  • enable you to implement risk management methods effectively.
  • provide practical experience through the included workshops and adequately prepare you for your next audit or inspection.

Detailed programme

Both days: 09:00-17:00
You can dial in 30 min before the course starts

08:45

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

09:00

FORUM

Welcome and introduction

09:15

Dr. Stefan Zohmann

The pharmacovigilance system - definitions, parties and legislation
GVP module I
  • The pharmacovigilance system
  • Authorities
  • Legislation: EU regulations and directives, CIOMS, ICH
  • GVP modules - structure and content

10:00

Anika Staack

Roles and responsibilities in PV
GVP module l
  • EU QPPV
  • Local QPPVs
  • Other responsibilities

10:45 Coffee break


11:00

Dr. Stefan Zohmann

Pharmacovigilance system master file (PSMF)
GVP module II
  • General information
  • Structure
  • Specific content

11:45

Anika Staack

Drug adverse effects
GVP module VI
  • Individual Case Safety Reports (ICSRs)
  • Procedures
  • Special cases
  • Proper follow-up procedures

12:30 Lunch


13:30

Dr. Eva Bauer

Periodic safety update report (PSUR)
GVP module VII
  • Legal basis and purpose
  • Benefit-risk analysis
  • Structure and content

14:15

Anika Staack

Post-authorisation safety studies (PASS)
GVP module VII
  • Study protocol
  • Study report
  • Roles and responsibilities in the EU network

15:15 Coffee break


15:30

Dr. Stefan Zohmann

Signal management
GVP module IX
  • Introduction
  • Structures and processes
  • Operation in the EU network

16:00

Anika Staack

Presentation and workshop: Additional monitoring
GVP module X

17:00 End of Day 1


08:45 Day 2 begins


09:00

Anika Staack, Dr. Stefan Zohmann

Roundup of day 1

09:15

Dr. Stefan Zohmann

The quality system in PV
GVP Module I
  • Overview
  • Standard operating procedures (SOPs) and work instructions (WIs)
  • Key performance indicators (KPIs)
  • Corrective and preventive actions (CAPAs)

10:45 Coffee break


11:00

Anika Staack, Dr. Stefan Zohmann

Workshop: Suitable key performance indicators (KPIs)
GVP Module I

11:45

Anika Staack, Dr. Stefan Zohmann

Workshop: Corrective and preventive actions (CAPAs)
GVP Module I

12:30 Lunch


13:30

Dr. Stefan Zohmann

Audits and inspections
GVP modules III and IV
  • Audits
  • Inspections
  • Requirements for pharmaceutical companies
  • Typical findings

14:15

Dr. Stefan Zohmann

Workshop: Inspection readiness
GVP modules III and IV

15:00 Coffee break


15:15

Anika Staack

Risk management
GVP modules V, XV and XVI, and annexes
  • Risk management system
  • Risk management plan (RMP)
  • Risk minimisation measures (RMMs)
  • Educational materials
  • Safety communication (annex II - templates DHPC and CP DHPC)

16:45

Anika Staack, Dr. Stefan Zohmann

Summary, questions and discussion

17:00 End of course


More information

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. 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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Go forward

List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

Details
Abbreviations, Glossary
In-house seminars

Our programmes are also available for in-house training. Just contact us!

Details
In-house seminars
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

Details
We guarantee the highest quality