Drug Safety and Good Vigilance Practice (GVP)

Introduzione

Pharmacovigilance is a discipline aimed at continuously assessing all information relating to the safety of medicinal products, both in development and on the market, and at ensuring that the risk-benefit ratio remains favourable.

This needs highly trained staff to ascertain both compliance as well as quality, whether in case reporting, aggregate reports, signaling, or in (re-)writing a Risk Management Plan.

The aim of the masterclass is to provide an understanding of the aims and objectives of pharmacovigilance, to examine the legislation in force, and to interpret and manage information on the safety of medicinal products. Thereby ensuring that participants can acquire the necessary tools to deal with day-to-day operations on an adequate knowledge basis.

Module 1 | Introduction

Introduction of Masterclass, Participants, Trainers

Introduction to Pharmacovigilance
- History and development of Pharmacovigilance (PV)
- Definitions EU and USA
- EU and US FDA regulations
- Introduction to Good Pharmacovigilance Practices (GVP)
- Adverse Drug Reactions and other PV relevant information (part I)

Module 2 | Case Management / GVP VI

Case Management of PV relevant information
- Adverse Drug Reactions and other PV relevant information (part II)
- Data entry and narrative writing
- MedDRA (Medical Dictionary for Regulatory Activities) Coding
- Assessment (seriousness / expectedness / listedness / causality)
- Privacy protection
- Submission to regulators

Module 3 | Periodic Reports / GVP VII

Periodic Benefit Risk Evaluation Reports
- Frequency – EURD list
- Table of Contents
- Tricky sections
- Summary Tabulations
- Submission and Assessment Reports
US PADERs
- Frequency
- Table of Contents
- Listings

Module 4 | Signal Management / GVP IX + XV

Signal Management
- Definitions and methods
- Qualitative vs. quantitative signal detection
- Use of Standardised MedDRA Queries (SMQs) and EVDAS (incl. EVDAS pilot)
- Assessment and documentation
- Safety Communication

Module 5 | Risk Management Plans / GVP V + X+ XVI

Risk Management Plans (EU)
- Safety Concerns
- Table of Contents
- RMP Commitments
- Additional Risk Minimisation, Additional PV Activities
- Additional Monitoring – List
US REMS
- Table of Contents
- Differences to EU / Waivers

Module 6 | Studies / GVP VIII / GCP

Clinical Trials
- Regulations (incl. Good Clinical Practice (GCP) and Clinical Trial Regulation)
- Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Investigator’s Brochure
- Development Safety Update Reports (DSURs)
Non-interventional studies and Post-Authorisation Studies
- Definitions
- Conduct and reporting

Module 7 | QPPV and PV System Master File / GVP I + II

EU Qualified Person responsible for Pharmacovigilance (QPPV)
- Expectations and qualifications
- Back-up
- Nomination
- Local Safety Officer
PV System Master File (PSMF)
- Responsibility and purpose
- Structure
- Key Performance Indicators (Part I)
- Deviations / Corrective and Preventive Actions (Part I)
- Update
- Availability and submission – Summary of the PV System

Module 8 | PV Compliance, Audits, Inspections / GVP III + IV

PV Compliance Management
- Definitions
- Indicators (Part II)
- Compliance Report
PV Audits and PV Inspections
- Audit universe
- Risk-based audit algorithm
- Preparation and conduct
- Report and follow up / Corrective and Preventive Actions (Part II)

Module 9 | PV Agreements and PV SOPS / GVP II

PV Agreements
- Need
- Structure / Content
- Escalation
- Review
PV SOPs
- Overview of PV SOPs
- Requirements and stumbling blocks
- Monitoring and update

Module 10 | PV Risk Assessment Committee (PRAC) / Safety Issues

PRAC
- Structure
- Responsibilities
- Examples of current activities
EU Referrals / Recalls
- Regulatory background
- Examples
Conclusion of Masterclass
- Insights and Learnings
- What is next?

This Masterclass is intended for staff in the first two years of their Pharmacovigilance experience (including new hires), for those who would like to update their knowledge, or for those who want to have a more complete overview of PV.

Frontal lessons, Q&A sessions, interactive training with polls and practical exercises.

Docente/i

Info

Dr. med. Renald Hennig

Senior Consultant at SCRATCH Pharmacovigilance GmbH & Co. KG

In addition to having more than 20 years of experience in Pharmacovigilance, he very much enjoys sharing and training. He is medically qualified as well as an MBA. His PV experience includes responsibilities as the QPPV for major pharmaceutical companies and significant auditing experiences. A quote he likes (from Sir Liam Donaldson): ‘To err is human, to cover up is unforgivable, and to fail to learn is inexcusable.’

Info

Dr. med. Susanne Kienzle-Horn

Senior Consultant at SCRATCH Pharmacovigilance GmbH & Co. KG

After completion of her medical degree, she added a computer science degree and a coaching certificate. Initial positions as a medical project manager were followed by more and more senior (Medical Director) and safety related functions, until she decided to become independent and founded SCRATCH in 2001. One of her favorite statements: ‘To listen is a silent yet fundamental statement.’

Info

Dr. rer. nat. Nicole Niemeier-Siegl

Scientific Manager Pharmacovigilance at SCRATCH Pharmacovigilance GmbH & Co. KG

She studied biology in Karlsruhe and in 2009 completed her doctoral thesis there at the Research Centre in the Helmholtz Association. After working as a scientific postdoc, she switched to pharmaceutical consulting, including training activities for pharmacy staff.
Since 2015, she has been working as Scientific Manager PV for SCRATCH Pharmacovigilance – in all areas of PV, with a focus on clinical trials and joy in imparting knowledge.

Info

Magnus Lühring

Senior PV Manager and PV Training Specialist at SCRATCH Pharmacovigilance GmbH & Co. KG

He got in touch with the world of PV as the first permanent employee at SCRATCH Pharmacovigilance in Sep 2005, directly after having completed his medical documentalist education.
His main area of work comprises ICSR processing in several different databases, incl. submission to authorities, handling of multiple EudraVigilance related tools (incl. registration / maintenance of companies and users), as well as holding PV seminars and webinars. He is also involved in trainee education. Since 2009 he is a Certified MedDRA Coder, since 2014 a TÜV-certified Pharmacovigilance Manager.

Durata e Informazioni utili
Quote Iscrizione

Dates TBD

After the registration, you will receive all details about the connection.

The Masterclass will be confirmed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Limited number: maximum 15 attendees.

The certificate of attendance of the whole training will be delivered to the participants who will attend the 80% of the training course at least.

Super Early Bird: € 2.980,00*

Early Bird: € 3.190,00*

Ordinary: € 3.980,00*

Freelance – Academy – Public Administration**: € 2.230,00*

* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials for each training and attendance certificate that will be sent after the complete masterclass via e-mail.

Versione Stampabile

Cosa saprai fare dopo il percorso formativo

Understand basic Pharmacovigilance processes and regulations

Point to relevant PV regulations

Show that you have gained significant knowledge on Good Pharmacovigilance Practices

Discuss intelligently the finer points of Pharmacovigilance

Online training path on Zoom platform.

LS Academy will provide the access link to the virtual platform a few days before each module.

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Pharmacovigilance Masterclass