Name: Pharmacovigilance Documents in the Life Cycle of a Medicinal Product: From Patients to Health Authorities
SKU: 2400
Availability: InStock

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:

Be your own documentalist and statistician:
– Signal management and data collection
– Evaluation of sources and data
Causality judgment: experience vs automation
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
RMP and PSUR: global planning and management
Experience from PSUR authority assessment reports: what really matters
Referrals: the worst pharmacovigilance challenge
Social network in Pharmacovigilance: a bubble that has burst
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

Info

Marco Anelli

Consulente Medical Affairs e Pharmacovigilance

Marco ha conseguito la laurea in medicina presso l’Università degli Studi di Milano, la specializzazione in Statistica Medica e Farmacologia Clinica presso l’Università degli Studi di Pavia e un master internazionale in economia sanitaria e farmacoeconomia presso l’Università Pompeu Fabra di Barcellona, oltre ad una formazione in Data Science e Intelligenza Artificiale.
Negli ultimi anni ha lavorato a lungo nei settori della farmacoeconomia e della valutazione delle tecnologie sanitarie.
Dal 2022 Marco è consulente libero professionista in Medical Affairs e Pharmacovigilance/Drug Safety.

In precedenza, è stato “Head of Pharmacovigilance and Medical Affairs Advisory Services” presso ProductLife Group (PLG).
In qualità di “Deputy Chief Scientific Officer”, sempre presso PLG, Marco ha inoltre coordinato tutti i progetti di fornitura e ricerca (interni e per conto dei clienti) legati a Big Data, Knowledge Management, Intelligenza Artificiale e Machine Learning.
In precedenza, Marco è stato R&D Director presso Keypharma, una società di consulenza con sede in Italia (poi acquisita da PLG), dove era responsabile della supervisione di tutti gli aspetti clinici e preclinici dei progetti gestiti internamente e per conto dei clienti.
Grazie a una carriera di oltre 30 anni nell’industria farmaceutica, Marco fornisce una supervisione esperta su un’ampia gamma di attività di R&S e Medical Affairs.
Marco ha partecipato e supervisionato tutte le fasi dello sviluppo di un farmaco, dalla formulazione alla Fase I-IV e alla farmacovigilanza.
Inoltre, Marco è un QPPV qualificato e ha preparato e supervisionato più di 200 documenti non clinici e clinici.
Prima di entrare in Keypharma e PLG, Marco è stato Medical Affairs Director di Eurand.

Info

Tiziana von Bruchhausen

Principal 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 Principal 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.

Durata e Informazioni utili
Quote Iscrizione

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.

CPD – Continuing Professional Development
This course qualifies for 10 hours for your CPD records. More about CPD

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.