Introduzione

This course introduces the AddCO, which represents an important milestone in the lifecycle of a drug and requires an approach that includes planning and  writing skills from both the PSUR and the Clinical Overview (Module 2.5).

Referrals, in addition, are “incidents” that could occur at any time during the lifecycle of a drug and that can have a significant impact on the “bottom line” of a product and need to be effectively managed through a joint team effort.

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
For the participation in these training courses is required:

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.


Online Training – 1 module

23 October 2024 from 01:30 pm to 05:30 pm CEST

 

The training 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.

***

This course is part of the training path Pharmacovigilance Documents in the Life Cycle of a Medicinal Product. 

Early Bird: € 510,00* (until 02/10/2024)

Ordinary: € 645,00*

Freelance – Individual – Academy – Public Administration**: € 385,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Individual – 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.

Roberta Alberti
Roberta Alberti
Events & Training Manager
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Know the requirements for AddCO, the document structure and content, and where to find guidance
Risultato atteso
Identify relevant topics and issues to be discussed in the document, as well as to plan the document preparation and effectively interact with the Experts and the other Company functions involved
Risultato atteso
Understand the structure and different types of referrals and, through the analysis of real life cases, learn how to plan and structure possible response and “damage-containment” structures

<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>