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
02 March 2022;  1 pm – 5 pm CET

  • 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
16 March 2022;  1 pm – 5 pm CET

  • 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
30 March 2022;  1 pm – 5 pm CEST

  • 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
13 April 2022;  1 pm – 5 pm CEST

  • 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
27 April 2022;  1 pm – 5 pm CEST

  • 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
11 May 2022;  1 pm – 5 pm CEST

  • 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 
25 May 2022;  1 pm – 5 pm CEST

  • 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 
08 June 2022;  1 pm – 5 pm CEST

  • 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 
22 June 2022;  1 pm – 5 pm CEST

  • 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 
06 July 2022;  1 pm – 5 pm CEST

  • 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
Dr. med. Renald Hennig
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.’

Dr. med. Susanne Kienzle-Horn
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.’

Dr. rer. nat. Nicole Niemeier-Siegl
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.

Magnus Lühring
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.

Module 1 | Introduction
02 March 2022;  1 pm – 5 pm CET

Module 2 | Case Management / GVP VI
16 March 2022;  1 pm – 5 pm CET

Module 3 | Periodic Reports / GVP VII
30 March 2022;  1 pm – 5 pm CEST

Module 4 | Signal Management / GVP IX + XV
13 April 2022;  1 pm – 5 pm CEST

Module 5 | Risk Management Plans / GVP V + X+ XVI
27 April 2022;  1 pm – 5 pm CEST

Module 6 | Studies / GVP VIII / GCP
11 May 2022;  1 pm – 5 pm CEST

Module 7 | QPPV and PV System Master File / GVP I + II 
25 May 2022;  1 pm – 5 pm CEST

Module 8 | PV Compliance, Audits, Inspections / GVP III + IV 
08 June 2022;  1 pm – 5 pm CEST

Module 9 | PV Agreements and PV SOPS / GVP II 
22 June 2022;  1 pm – 5 pm CEST

Module 10 | PV Risk Assessment Committee (PRAC) / Safety Issues 
06 July 2022;  1 pm – 5 pm CEST

 

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* (until 31 December 2021)

Early Bird: € 3.190,00* (until 02 February 2022)

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.

Acquista
Super Early Bird
Acquistabile fino al 31/12/2021
2.980,00
Early bird
Acquistabile fino al 02/02/2022
3.190,00
Ordinary
Acquistabile fino al 01/03/2022
3.980,00
Freelance – Academy – Public Administration
Acquistabile fino al 01/03/2022
2.230,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il percorso formativo
Risultato atteso
Understand basic Pharmacovigilance processes and regulations
Risultato atteso
Point to relevant PV regulations
Risultato atteso
Show that you have gained significant knowledge on Good Pharmacovigilance Practices
Risultato atteso
Discuss intelligently the finer points of Pharmacovigilance

<p>Online training path on Zoom platform.</p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before each module.</em></p>

Online training path on Zoom platform.

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

<p>Online training path on Zoom platform.</p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before each module.</em></p>