European Regulatory Affairs Forum 2024

21, 28 Maggio 2024
Online
English
 

Panoramica della conferenza

Pharma Education Center is excited to extend a warm invitation to all regulatory affairs professionals to participate in the upcoming European Regulatory Affairs Forum.

As the annual meeting of European Regulatory Affairs experts, the Forum aims to foster an environment of knowledge-sharing. We are proud to provide a platform for industry professionals to exchange their experiences, highlight current issues and changes, discuss effective strategies, and explore new trends within the European Regulatory Affairs landscape.
In addition to fostering networking opportunities, the Forum will feature experts who will share their invaluable “hands-on” experiences.
This will provide delegates with a unique opportunity to gain practical insights and enhance their professional skill sets.

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
  • RegulatoryBody Representatives
  • New Technologies Suppliers
  • Consultants from all over Europe

Perchè partecipare?

The Forum brings together International Regulatory Affairs experts, Opinion Leaders, Regulatory Body representatives, and Consultants, making this a must-go event for Pharma, Biotech, and Medical Device Industries.

A chi è rivolto?

Regulatory Affairs & Market Access VP, Directors, Manager, Head and Professionals of Pharma, Biotech and Medical Device Industries.

Topics 2024

SESSION I – May 21st
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.

SESSION II – May 28th
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/CTR.
Gain insights into these updates and understand how they may affect your work in Regulatory Affairs.

SESSION III – May 28th
European Health Technology Assessment (EU HTA):
A New Paradigm for Assessing the Effectiveness, Safety, and Value of Drugs and Medical Devices

The introduction of the HTA Regulation (HTAR) in 2022 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 joint clinical assessment 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 Member States legislative landscape. Gain insights into the implementation acts and framework 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 delegates.

21 Maggio, SESSION I - Revolutionizing Regulatory Affairs: Harnessing Artificial Intelligence and Digitalization for Enhanced Processes


Welcome and Introduction

Chairperson | Pharma Education Center

Opening Remarks

Raffaella Pandini, RA Director | Pharma D&S

Impacts of AI in the Overall Drug Lifecycle

Gabriele Breda, Research & Innovation Director | PLG

EU AI ACT: Overview and Main Challenges

Patrizia Ciavatta, Global Regulatory & Pharmacovigilance Chief  | Angelini Pharma

Impacts of Eu AI ACT on Regulatory Activities

Aymeric Lebon, Commercial Director | Medtech

Q&A Time
ePI in the EU – Key Principles

Laurence Brihaye, Formerly Associate Director European Regulatory Procedure Strategy at a Top-10 Biopharma Company

Moderna’s Case Study of ePI During the Pandemic and Beyond

Colleen McGraw, Sr. Director, Global Regulatory
Labeling | Moderna (US)

Q&A Time
ROUND TABLE - How can AI be Integrated and Digitalized Into Our Regulatory Framework? Challenges & Opportunities

Moderator: Gabriele Breda

Panelists: Laurence Brihaye; Patrizia Ciavatta; Aymeric Lebon; Colleen McGraw

Closure of the Day

Raffaella Pandini, RA Director | Pharma D&S

28 Maggio, SESSION II - EU Legislation: What’s New?


Introduction

Raffaella Pandini, RA Director | Pharma D&S

A Snapshot on EU Regulatory Landscape: What’s New? New EU Guidance on MA Variations, PRIME-Priority Medicines Scheme Shortage Prevention Plan (SPP) & Shortage Management Plan (SMP)

Angela Esposito, Head of Global Regulatory Policy
& Strategy | Angelini Pharma

EU-CTR & CTIS Updates: A Closer Look from a Regulatory Perspective

Anna Carratù, Senior Global Program Regulatory
Manager | Novartis

Q&A Time
EU Patent Package Overview and Key Messages Impacting RA

Barbara Politi, Innovation & IP Expert | Addì srl

Q&A Time

28 Maggio, SESSION III - European Health Technology Assessment (EU HTA): A New Paradigm for Assessing the Effectiveness, Safety, and Value of Drugs and Medical Devices


Introduction

Mariangela Prada, General Manager | Intexo

The Implementation of the New HTA Regulation: Expected Benefits and Challenges for 2025

Entela Xoxi, Lecturer with Collaboration Agreement for Research Projects | Università Cattolica del Sacro Cuore of Rome Italy

ROUND TABLE How to prepare for the future of EU HTA?

Moderator: Entela Xoxi

Panelists: Paolo Dametto, Alessandra Sinibaldi, Filippo Rumi

Closure of the Session

Mariangela Prada, General Manager | Intexo

Closure of the Day

Raffaella Pandini, RA Director | Pharma D&S

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


Gabriele Breda

Gabriele Breda

Research & Innovation Director | PLG

Laurence Brihaye

Laurence Brihaye

Formerly Associate Director European Regulatory Procedure Strategy, at a Top-10 Biopharma Company

Anna Carratù

Anna Carratù

Senior Global Program Regulatory Manager | Novartis

Patrizia Ciavatta

Patrizia Ciavatta

Global Regulatory & PV Chief | Angelini Pharma

Angela Esposito

Angela Esposito

Head of Global Regulatory Policy & Strategy | Angelini Pharma

Aymeric Lebon

Aymeric Lebon

Commercial Director | Medtech

Colleen McGraw

Colleen McGraw

Sr. Director, Global Regulatory Labeling | Moderna (US)

Barbara Politi

Barbara Politi

Innovation & IP Expert | Addì srl

Mariangela Prada

Mariangela Prada

General Manager | Intexo

Entela Xoxi

Entela Xoxi

Senior Scientific Advisor & Lecturer with Collaboration Agreement for Research Projects | Università Cattolica del Sacro Cuore of Rome, Italy

Alessandra Sinibaldi

Alessandra Sinibaldi

Value, Market Access & Gov. Affairs Sr Director | Alfasigma

Filippo Rumi

Filippo Rumi

Researcher | ALTEMS

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.
Want to become a sponsor of 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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