European Regulatory Affairs Forum 2025
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 2025 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 2025 IN PROGRESS
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
Chairperson | Pharma Education Center
Raffaella Pandini, RA Director | Pharma D&S
Gabriele Breda, Research & Innovation Director | PLG
Patrizia Ciavatta, Global Regulatory & Pharmacovigilance Chief | Angelini Pharma
Aymeric Lebon, Commercial Director | Medtech
Laurence Brihaye, Formerly Associate Director European Regulatory Procedure Strategy at a Top-10 Biopharma Company
Colleen McGraw, Sr. Director, Global Regulatory
Labeling | Moderna (US)
Moderator: Gabriele Breda
Panelists: Laurence Brihaye; Patrizia Ciavatta; Aymeric Lebon; Colleen McGraw
Raffaella Pandini, RA Director | Pharma D&S
28 Maggio, SESSION II – EU Legislation: What’s New?
Raffaella Pandini, RA Director | Pharma D&S
Angela Esposito, Head of Global Regulatory Policy
& Strategy | Angelini Pharma
Anna Carratù, Senior Global Program Regulatory
Manager | Novartis
Barbara Politi, Innovation & IP Expert | Addì srl
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
Mariangela Prada, General Manager | Intexo
Entela Xoxi, Lecturer with Collaboration Agreement for Research Projects | Università Cattolica del Sacro Cuore of Rome Italy
Moderator: Entela Xoxi
Panelists: Paolo Dametto, Alessandra Sinibaldi, Filippo Rumi
Mariangela Prada, General Manager | Intexo
Raffaella Pandini, RA Director | Pharma D&S
Scientific Board 2024 – SCIENTIFIC BOARD 2025 IN PROGRESS
Ilaria Brocchi
Regulatory Affairs Senior Project Manager | Pharma D&S, a PLG Company
Patrizia Ciavatta
Global Regulatory & PV Chief | Angelini Pharma
Paolo Dametto
Director, Regulatory Affairs | Deciphera
Raffaella Pandini
Regulatory Affairs Director | Pharma D&S, a PLG Company
Speakers 2024 – SPEAKERS 2025 IN PROGRESS
Gabriele Breda
Research & Innovation Director | PLG
Laurence Brihaye
Formerly Associate Director European Regulatory Procedure Strategy, at a Top-10 Biopharma Company
Anna Carratù
Senior Global Program Regulatory Manager | Novartis
Patrizia Ciavatta
Global Regulatory & PV Chief | Angelini Pharma
Angela Esposito
Head of Global Regulatory Policy & Strategy | Angelini Pharma
Aymeric Lebon
Commercial Director | Medtech
Colleen McGraw
Sr. Director, Global Regulatory Labeling | Moderna (US)
Barbara Politi
Innovation & IP Expert | Addì srl
Mariangela Prada
General Manager | Intexo
Entela Xoxi
Senior Scientific Advisor & Lecturer with Collaboration Agreement for Research Projects | Università Cattolica del Sacro Cuore of Rome, Italy
Alessandra Sinibaldi
Value, Market Access & Gov. Affairs Sr Director | Alfasigma
Filippo Rumi
Researcher | ALTEMS
Sponsors 2025
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!
- Online
Sede del congresso
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
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 2025 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 2025 IN PROGRESS
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
Chairperson | Pharma Education Center
Raffaella Pandini, RA Director | Pharma D&S
Gabriele Breda, Research & Innovation Director | PLG
Patrizia Ciavatta, Global Regulatory & Pharmacovigilance Chief | Angelini Pharma
Aymeric Lebon, Commercial Director | Medtech
Laurence Brihaye, Formerly Associate Director European Regulatory Procedure Strategy at a Top-10 Biopharma Company
Colleen McGraw, Sr. Director, Global Regulatory
Labeling | Moderna (US)
Moderator: Gabriele Breda
Panelists: Laurence Brihaye; Patrizia Ciavatta; Aymeric Lebon; Colleen McGraw
Raffaella Pandini, RA Director | Pharma D&S
28 Maggio, SESSION II - EU Legislation: What’s New?
Raffaella Pandini, RA Director | Pharma D&S
Angela Esposito, Head of Global Regulatory Policy
& Strategy | Angelini Pharma
Anna Carratù, Senior Global Program Regulatory
Manager | Novartis
Barbara Politi, Innovation & IP Expert | Addì srl
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
Mariangela Prada, General Manager | Intexo
Entela Xoxi, Lecturer with Collaboration Agreement for Research Projects | Università Cattolica del Sacro Cuore of Rome Italy
Moderator: Entela Xoxi
Panelists: Paolo Dametto, Alessandra Sinibaldi, Filippo Rumi
Mariangela Prada, General Manager | Intexo
Raffaella Pandini, RA Director | Pharma D&S
Scientific Board 2024 - SCIENTIFIC BOARD 2025 IN PROGRESS
Ilaria Brocchi
Regulatory Affairs Senior Project Manager | Pharma D&S, a PLG Company
Patrizia Ciavatta
Global Regulatory & PV Chief | Angelini Pharma
Paolo Dametto
Director, Regulatory Affairs | Deciphera
Raffaella Pandini
Regulatory Affairs Director | Pharma D&S, a PLG Company
Speakers 2024 - SPEAKERS 2025 IN PROGRESS
Gabriele Breda
Research & Innovation Director | PLG
Laurence Brihaye
Formerly Associate Director European Regulatory Procedure Strategy, at a Top-10 Biopharma Company
Anna Carratù
Senior Global Program Regulatory Manager | Novartis
Patrizia Ciavatta
Global Regulatory & PV Chief | Angelini Pharma
Angela Esposito
Head of Global Regulatory Policy & Strategy | Angelini Pharma
Aymeric Lebon
Commercial Director | Medtech
Colleen McGraw
Sr. Director, Global Regulatory Labeling | Moderna (US)
Barbara Politi
Innovation & IP Expert | Addì srl
Mariangela Prada
General Manager | Intexo
Entela Xoxi
Senior Scientific Advisor & Lecturer with Collaboration Agreement for Research Projects | Università Cattolica del Sacro Cuore of Rome, Italy
Alessandra Sinibaldi
Value, Market Access & Gov. Affairs Sr Director | Alfasigma
Filippo Rumi
Researcher | ALTEMS
Sponsors 2025
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!
- Online
Sede del congresso
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
Iscriviti alla conferenza
Modulo I |
€ |
Modulo II |
€ |
Tutti i moduli |
€ |
* Ospedali, università e liberi professionisti ottengono uno sconto del 40% da applicare ai prezzi pubblicati (gli sconti non sono cumulabili).