Introduzione

This training path in 6 modules (total 24 hours) of highly interactive online training is designed to give an extensive 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
  • consolidated documents in the different phases of the life cycle
  • structure and content of consolidated documents
  • similarities, differences and synergies among the various documents

MODULE 1 | 13 September 2023
Pharmacovigilance Documents – Basic Concepts and Definitions for Pharmacovigilance Writing

“A never ending story (life cycle management in pharmacovigilance)”

  • The life cycle of a medicinal product from the pharmacovigilance perspective
  • Basic concepts and definitions for pharmacovigilance writing
  • Benefit-risk analysis
  • Breakout sessions and interactive discussion of the results
  • Interaction of the main pharmacovigilance documents through the life cycle of medicinal products.
  • Assessment and review of key concepts

MODULE 2 | 20 September 2023
Pharmacovigilance Documents – Focus on Signal Management and Development Safety Update Reports (DSUR)

“The early phases: Signals and Trials”

  • Focus on the Development Safety Update Report (DSUR)
    • Who, when, what and how.
  • Breakout sessions and interactive discussion of the results
  • Signal management
    • Evaluation of sources
    • Signal management and data collection
    • The Signal Detection and Management Report
  • Breakout sessions and interactive discussion of the results
  • Assessment and review of key concepts

MODULE 3 | 26 September 2023 
Pharmacovigilance Documents – Focus on the Risk Management Plan (RMP)

“The life beyond submission, 1: Risks and Plans”

  • Focus on the RMP (Risk Management Plan)
    • Who, when, what and how.
  • Life cycle of the safety concerns in RMPs: not all risks are created equal
  • Review of the list of safety concerns according to the GVP V Rev.2 module
  • Examples from renewal assessment reports
  • Review of safety concerns: RMP and PSUR, align or not align?
  • Safety concerns in RMP and PSUR: from theory to practice
  • Breakout sessions and interactive discussion of the results
  • Assessment and review of key concepts

MODULE 4 | 28 September 2023 
Pharmacovigilance Documents – Focus on the Periodic Safety Update Report  (PSUR)

“The life beyond submission 2: The PSUR (Periodic Safety Update Report)”

  • Focus on PSURs: requirements, structure and content
  • Breakout sessions and interactive discussion of the results
  • RMPs and PSURs: things to consider
  • Assessment and review of key concepts

MODULE 5 | 11 October 2023 
Pharmacovigilance Documents – Focus on the Periodic Safety Update Report  (PSUR)

“The life beyond submission 3: The PSUR, again”

  • PSUR writing: challenges and pitfalls
  • Document assessment and evaluation
  • Experience from PSUR authority assessment reports: what really matters
  • Preparation for the role playing: “plan, plan, plan…!”
  • Role play: design your own PSUR
  • Assessment and review of key concepts

MODULE 6 | 18 October 2023
Pharmacovigilance Documents – Focus on Addendum to the Clinical Overview (AddCO) and Referrals

“The Expected and the Unexpected: AddCOs and Referrals”

  • The Addendum to the Clinical Overview : an important milestone
    • From the Module 2.5 to the AddCo
    • Breakout sessions and interactive discussion of the results
  • The Referral: the worst Pharmacovigilance nightmare…?
    • What could happen
    • What has happened
    • What should happen
  • Breakout sessions and interactive discussion of the results
  • Assessment and review of key concepts

Professionals involved in the planning, preparation, coordination and review of aggregated 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

Medical Affairs and Pharmacovigilance consultant

Marco has a medical degree from the University of Milan, specializations in Medical Statistics and Clinical Pharmacology from the University of Pavia and an international master’s degree in health economics and pharmacoeconomics from the University of Pompeu Fabra in Barcelona, plus formal training in Data Science and Artificial Intelligence.
In the last few years, he has extensively worked in the fields of pharmacoeconomics and health technology assessment.
Marco has been a free-lance consultant in Medical Affairs and Pharmacovigilance/ Drug Safety since 2022.

Before that, he has been “Head of Pharmacovigilance and Medical Affairs Advisory Services” at ProductLife Group (PLG).
As “Deputy Chief Scientific Officer”, always at PLG, Marco has also coordinated all delivery and research projects (internal and on behalf of clients) linked to Big Data, Knowledge Management, Artificial Intelligence and Machine Learning.
Previously, Marco was R&D Director at Keypharma, an Italy-based consultancy company (later acquired by PLG), where was responsible for the oversight of all clinical and preclinical aspects of projects run internally and on behalf of clients.
Drawing on a career in the pharmaceutical industry that spans more than 30 years, Marco provides expert oversight on a wide range of R&D and Medical Affairs related activities.
Marco has participated in and supervised all stages of drug development – from formulation to Phase I-IV and pharmacovigilance.
In addition, Marco is a qualified QPPV and has prepared and overseen more than 200 non-clinical and clinical overviews and summaries.
Before joining Keypharma and PLG, Marco was Medical Affairs Director at Eurand.


Tiziana von Bruchhausen
Info

Tiziana von Bruchhausen

Principal Pharmacovigilance Writer at Boehringer Ingelheim

Tiziana von Bruchhausen, PhD specialises in pharmacovigilance writing and has gained over 10 years’ experience while working in various roles for mid-sized and large pharmaceutical companies. She is currently employed as a principal pharmacovigilance writer at Boehringer Ingelheim. Her tasks and responsibilities cover pre- and post-submission activities related to the global strategic planning and the preparation of pharmacovigilance documents with a focus on DSURs, RMPs, PSURs, and health authorities’ assessment reports.
Tiziana actively promotes the professional role of medical writers in pharmacovigilance through workshops and lectures Europe-wide and has served as a session chair at international conferences. She is an active volunteer at the European Medical Writers Association (EMWA), where she has been chairing since 2017 the Pharmacovigilance Special Interest Group Committee. She was Vice President of EMWA in 2017-2018 and President in 2018-2019.


The training path is made of 6 modules:

MODULE 1 | Pharmacovigilance Documents – Basic Concepts and Definitions for Pharmacovigilance Writing
13 September 2023 – h.09:00 am / 01:00 pm CEST

MODULE 2 | Pharmacovigilance Documents – Focus on Signal Management and Development Safety Update Reports (DSUR)
20 September 2023 – h.09:00 am / 01:00 pm CEST

MODULE 3 | Pharmacovigilance Documents – Focus on the Risk Management Plan (RMP)
26 September 2023 – h.09:00 am / 01:00 pm CEST

MODULE 4-5 | Pharmacovigilance Documents – Focus on the Periodic Safety Update Report  (PSUR)
28 September 2023 – h.09:00 am / 01:00 pm CEST
11 October 2023 – h.09:00 am / 01:00 pm CEST

MODULE 6 | Pharmacovigilance Documents – Focus on Addendum to the Clinical Overview (AddCO) and Referrals
18 October 2023 – h. 09:00 am / 01:00 pm CEST

The modules of this training path are a series of standalone training courses. Visit each course online brochure for more information. Click here

The training path admits maximum 12 attendees.

The training path 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.

 

Super Early Bird: € 1.980,00* (unti 01 June 2023)

Early Bird: € 2.250,00* (until 23 August 2023)

Ordinary: € 2.560,00*

Freelance – Academy – Public Administration**: € 1.570,00*

* 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 percorso formativo
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>