European Regulatory Affairs Forum 2024

21, 28 Maggio 2024
Online
English
 

Panoramica della conferenza

Pharma Education Center warmly invites regulatory affairs professionals to take part to the next “EUROPEAN REGULATORY AFFAIRS FORUM”, which will take place virtually on the 21st and 28th of May.

The Forum represents the annual meeting of European Regulatory Affairs experts, willing to share experiences and last updates on current issues, changes, strategies and new trends in the European Regulatory Affairs landscape. The conference wishes to offer networking opportunities and promote debate among European Regulatory Affairs delegates.

The Forum will offer a fruitful occasion to address some practical aspects, thanks to the precious contribution of experts in the field, sharing their own “hands-on” experience.

Format del congresso

The European Regulatory Affairs Forum 2024 will be virtual.

Participants will be able to discuss directly in round tables and specific Q&A sessions with:

  • Regulatory Affairs experts
  • Opinion leaders
  • Regulatory body representatives
  • New technologies suppliers
  • Consultants from all over Europe

Perchè partecipare?

The Forum will feature several sessions on the hot topics of the moment, with case studies, interactive Q&A moments and round tables with the involvement of all the delegates: a great opportunity to understand different points of view and expertise.

The involvement of international Regulatory Affairs experts, opinion leaders, regulatory body representatives, new technologies suppliers and consultants from all over Europe, make this a must-go event for Pharma, Biotech, Medical Device companies and for IT Suppliers.

A chi è rivolto?

Regulatory Affairs, Regulatory Compliance, Quality Assurance, Business Development, Strategic Marketing, Direzione Medica, Ricerca Clinica e Informazione scientifica.

Topics 2024

May 21st, 2-6pm
Session 1 – Revolutionizing Regulatory Affairs:
Harnessing Artificial Intelligence and Digitalization for Enhanced Processes

Explore the transformative potential of AI and digitalization in regulatory affairs with our expert’s panel. Starting from the EMA ‘s AI workplan extending to 2028, to the EU Regulation Proposal, and the Reflection Paper on AI’s role in medicine lifecycles, delve into the journey towards the EU AI ACT regulation.

Discover how these technologies can enhance the Healthcare ecosystem bringing significant improvements by streamlining processes, accelerating drug development, and fostering transparency. We will discuss how to integrate AI and digitalization into our regulatory framework discovering the benefits; we will also explore the challenges behind it and the need of having clear rules to deal with these emerging technologies.

Reimagining regulatory processes: How can AI and digitalization optimize and reshape our current regulatory activities?
Keynote presentations followed by a final panel discussion with participants.

 

May 28th, 2-6pm
Session 2 – EU Legislation: What’s New?
Welcome to our informative session on the latest updates from EU legislation impacting Regulatory Affairs. Our experts will cover key changes related to PRIME, SPP & SMP, EU Guidance on MA Variations, and CTIS.
Gain insights into these updates and understand how they may affect your
work in Regulatory Affairs.

Session 3 – European Health Technology Assessment (EU HTA):
A New Paradigm for Assessing the Effectiveness, Safety, and Value of Drug and Medical Devices
The introduction of the HTA Regulation (HTAR) in 2021 marks a significant milestone in the field of Health Technology Assessment (HTA). Join us as we explore how this new legislation heralds a new era in evaluating the effectiveness, safety, and value of pharmaceuticals and medical devices.
During this session, we will address the objectives of the HTAR, aimed to improve patient access by reducing duplication of assessment efforts while ensuring reproducibility and fostering collaboration across the regulatory landscape.
Gain insights into the specific regulations and guidelines outlined in the HTAR and how they impact the assessment process and illuminate the pathways towards improved clinical evaluations.
Be part of the discussion where our experts will present the main objectives
that this new regulation will get.
Keynote presentations followed by a final panel discussion with the involvement of speakers and delegate

Non ci sono sessioni in agenda.

Scientific Board


Ilaria Brocchi

Ilaria Brocchi

Regulatory Affairs Senior Project Manager | Pharma D&S a PLG company

Patrizia Ciavatta

Patrizia Ciavatta

Global Regulatory & PV Chief | Angelini Pharma

Paolo Dametto

Paolo Dametto

Director, Regulatory Affairs | Deciphera

Raffaella Pandini

Raffaella Pandini

Regulatory Affairs Director |Pharma D&S a PLG company

Speakers 2024 - IN PROGRESS


In lavorazione.

Sponsors 2024

Diventa sponsor

The European Regulatory Affairs Forum 2024 provides an excellent opportunity to get in touch with Regulatory Affairs experts, opinion leaders, regulatory body representatives, new technologies suppliers and consultants from all over Europe. To sponsor the forum, contact us!

Sede del congresso

The European Regulatory Affairs Forum 2024 will be virtual.

The forum will be VIRTUAL to give you the opportunity to participate even from your office or home, wherever you are.

We have organized a real virtual location, a space where you can:

  • Follow the live streaming of the congress, listen to experts and opinion makers and find out about the latest updates;
  • Confront experts in the specific Q&A sections.

Edizioni precedenti

Scarica le brochure delle precedenti edizioni di European Regulatory Affairs Forum 2024

Iscriviti alla conferenza

Modulo I
Early bird fino al 21/04/2024*

350€
400€

Modulo II
Early bird fino al 21/04/2024*

350€
400€

Tutti i moduli
Early bird fino al 21/04/2024*

600€
700€

* Ospedali, università e liberi professionisti ottengono uno sconto del 40% da applicare ai prezzi pubblicati (gli sconti non sono cumulabili).

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