Introduzione

This course gives an overview of the pharmacovigilance activities and the related documents throughout the life cycle of a medicinal product.
We will address:

  • benefit-risk analysis
  • signal management
  • data collection process
  • regulatory, format and content requirements.

While the course is based on the EU requirements, a few relevant insights about the most relevant local requirements will be provided.
The participants will learn how to plan and manage PSURs and other pharmacovigilance documents in the life cycle and how to address selected challenges of document preparation.

MODULE 1: A never ending story (life cycle management in pharmacovigilance)

  • Introduction of participants
  • Objectives of the modules
  • Fine-tuning according to the participants’ needs (“deep dive” topics)
  • The life cycle of a medicinal product from the pharmacovigilance perspective
  • Benefit-risk analysis
  • Breakout sessions and interactive discussion of the results
  • “Deep dive”: see list of topics below
  • Assessment and review of key concepts

MODULE 2: The main actors

  • Basic concepts and definitions for pharmacovigilance writing
  • Breakout sessions and interactive discussion of the results
  • Interaction of the main pharmacovigilance documents through the life cycle of medicinal products:
    – Development Safety Update Report (DSUR)
    – Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
    – Risk Management Plan (RMP)
    – Addendum to Clinical Overview (AddCO)
  • Focus on DSURs
  • Breakout sessions and interactive discussion of the results
  • Focus on RMPs
  • Breakout sessions and interactive discussion of the results
  • “Deep dive”: see list of topics below
  • Assessment and review of key concepts

MODULE 3: The life beyond submission

  • Life cycle of the safety concerns in RMPs: not all risks are created equal
  • Breakout sessions and interactive discussion of the results
  • Assessment reports on RMPs and impact on PSURs
  • Focus on PSURs: requirements, structure and contents
  • Breakout sessions and interactive discussion of the results
  • “Deep dive”: see list of topics below
  • Assessment and review of key concepts

MODULE 4: Focus on PSUR

  • PSUR writing: challenges and pitfalls
  • Document assessment
  • Preparation for the role playing: plan, plan, plan
  • Role play: design your own PSUR
  • “Deep dive”: see list of topics below
  • Assessment and review of key concepts

“Deep dives” topics: additional topics that could be addressed in detail according to the attendees’ interest:

  1. Be your own documentalist and statistician:
    – Signal management and data collection
    – Evaluation of sources and data
  2. Causality judgment: experience vs automation
  3. Safety concerns in RMP and PSUR: from theory to practice
    – Review of the list of safety concerns according to the GVP V Rev.2 module
    – Examples from renewal assessment reports
    – Review of safety concerns: alignment of RMP and PSUR
  4. RMP and PSUR: global planning and management
  5. Experience from PSUR authority assessment reports: what really matters
  6. Referrals: the worst pharmacovigilance challenge
  7. Social network in Pharmacovigilance: a bubble that has burst
  8. New technologies in pharmacovigilance (artificial intelligence etc.)

Professionals involved in the planning, preparation and review of consolidated Safety reports.
In particular: Drug Safety and Pharmacovigilance department, Regulatory Affairs department and Quality and Compliance department (e.g. medical writers, pharmacovigilance writers, pharmacovigilance officers, pharmacovigilance managers, QPPVs, safety physicians, managers regulatory affairs and medical evaluators/advisors, document quality and compliance managers).

Participant experience
Basic knowledge of drug development and pharmacovigilance.

Presentation, hands-on exercises, group, and class discussions with a limited number of attendees.

Docente/i
Marco Anelli
Info

Marco Anelli

Senior Medical Advisor - PLG (Product Life Group)
Marco è stato nominato nel gennaio 2016 “Head of Pharmacovigilance and Medical Affairs Advisory Services” presso la PLG. In qualità di “Deputy Chief Scientific Officer” di PLG, Marco coordina tutti i progetti di deliverable e ricerca (interni e per conto di clienti) relativi ai Big Data, alla Gestione delle Conoscenza, all’Intelligenza Artificiale e al Machine Learning. In precedenza, Marco è stato direttore R&D di Keypharma, una società del gruppo ProductLife con sede in Italia, dove era responsabile del coordinamento di tutti gli aspetti clinici e preclinici dei progetti condotti internamente e per conto dei clienti. Grazie ad una carriera nell’industria farmaceutica di oltre 25 anni, Marco fornisce una supervisione esperta su una vasta gamma di attività di ricerca e sviluppo e di Medical Affairs. Ha partecipato e coordinato tutte le fasi dello sviluppo del farmaco, dalla formulazione alla fase I-IV e alla farmacovigilanza. Inoltre, è un QPPV qualificato e ha preparato e supervisionato più di 200 “overviews and summaires” clinici e non clinici. Marco è stato anche Medical Affairs Director di Eurand. Negli ultimi anni ha approfondito nei settori della valutazione farmaco-economica e delle tecnologie sanitarie. Laureato in medicina presso l’Università di Milano, specializzazioni in Statistica medica e Farmacologia clinica presso l’Università di Pavia, ha anche conseguito un master internazionale in economia sanitaria e farmacoeconomia presso l’Università Pompeu Fabra di Barcellona. 

Tiziana von Bruchhausen
Info

Tiziana von Bruchhausen

Senior Pharmacovigilance Writer presso Boehringer Ingelheim
Tiziana è specializzata in pharmacovigilance writing e conta più di 10 anni di esperienza dopo aver ricoperto diversi ruoli in aziende farmaceutiche di medie e grandi dimensioni. Attualmente lavora come Senior Pharmacovigilance Writer a Boehringer Ingelheim. Tra le sue mansioni, vi sono le attività di pre e post submission della strategia globale aziendale e la preparazione di documentazione di farmacovigilanza e in particolare di DSUR, RMP, PSUR e Authority Assessments Reports. Tiziana promuove attivamente il ruolo professionale dei medical writer nella farmacovigilanza attraverso seminari e corsi in tutta Europa ed è stata moderatrice in conferenze internazionali. È volontaria attiva presso la European Medical Writers Association (EMWA), dove dal 2017 presiede il comitato del Pharmacogiliance Special Interest Group. È stata vicepresidente dell’EMWA dal 2017 al 2018 e presidente dal 2018 al 2019.

Online Training – 4 modules

MODULE 1 | 18 May 2021 from 09:30 am to 1:00 pm CEST
MODULE 2 | 20 May 2021 from 09:30 am to 1:00 pm CEST
MODULE 3 | 25 May 2021 from 09:30 am to 1:00 pm CEST
MODULE 4 | 28 May 2021 from 09:30 am to 1:00 pm CEST

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

The course admits maximum 12 attendees.
The course will proceed 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.

Early Bird: € 1.420,00* (until 30 April 2021)

Ordinary: € 1.620,00*

Freelance – Academy – Public Administration**: € 920,00*

* 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 and attendance certificate that will be sent after the training via e-mail.


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Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the main pharmacovigilance activities in the life cycle of the medicinal product
Risultato atteso
Plan and prepare DSUR, PSUR/PBRER, RMP, and AddCO, exploiting similarities and synergies among the different documents
Risultato atteso
Apply writing skills to the preparation of pharmacovigilance documents

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

Online interactive training on Zoom platform.

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

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