Challenges for Researchers and Regulators facing the pandemic crisis
The unprecedented COVID-19 emergency has had a huge impact on the whole society as well as on the prompt availability of effective medicines, questioning the Pharmaceutical System worldwide.
The Coronavirus pandemic clearly demonstrates the need to revise some of the cornerstones of the European Pharmaceutical System and of the drug development process in order to properly meet patients’ needs and ensure them timely access to medicines under all circumstances.
Annually, Fondazione Gianni Benzi organises the Foresight Training Course (FTC), a short international course aimed to promote pharmacological research and innovation. The pandemic has had an impact on our activities too, but we do not give up!
Therefore, this year, due to the restrictions enforced, the XIII FTC will run virtually and in a shorter version on 23 October 2020 at 09:30 AM (CEST). It will be focused on how the pandemic crisis forced the European Regulatory Pharmaceutical System to change.
We want to discuss the proposed European Union (EU) new strategy, just launched in the pandemic framework, that aims to improve and accelerate patients’ access to high-quality, safe and affordable medicines and to support further innovation in the European pharmaceutical industry.
The first session of the course will exactly address this new European strategy, giving way to the Health Authorities and Regulators as well as to different stakeholders involved in the announced revolution of the EU Pharmaceutical System.
Experts from companies, healthcare professionals, researchers and patients’ groups will share their contribution representing the key points to be discussed during the meeting.
Fondazione Benzi, that has always been actively committed in contributing to the regulatory debate, will gather all the considerations from stakeholders and will guide this process.
The EU pharmaceutical debate includes the proposal to revise two main EU Pharmaceutical System pillars: the Orphan Medicines Regulation and the Paediatric Regulation, that will be deeply considered in a dedicated window of the meeting in order to discuss possible improvement and administrative simplification without reducing their relevance for patients, companies and researchers.
Here below you can freely consult some useful material including highlights, presentations and recordings.
AGENDA
09:30 – 09:40
Introductory remarks
Adriana Ceci, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Session 1 – The COVID-19 emergency and the European pharmaceutical system: strengths and weaknesses
Chairs Fedele Bonifazi & Vincenzo Salvatore
09:40 – 10:00
The new Pharmaceutical Strategy for Europe – Timely patient access to affordable medicines: key points and challenges
Fabio D’Atri, European Commission
10:00 – 10:20
The increased value of the EC consultation to promote the new strategy
Viviana Giannuzzi & Enrico Bosone on behalf of Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
10:20 – 10:40
Company perspective
Ansgar Hebborn, La Roche AG
10:40 – 11:00
Patients’ perspective
François Houyez, EURORDIS
11:00 – 11:20
Q&A session
11:20 – 11:40
Coffee Break
Session 2 – COVID-19 accelerates research and development of new medicines and vaccines
Chairs Cosimo Altomare & Adriana Ceci
11:40 – 12:00
The EMA regulatory framework for timely approval of new and innovative drugs and vaccines in the pandemic era
Marco Cavaleri, European Medicines Agency
12:00 – 12:20
Company perspective
Martin F. Ryser, Janssen-Cilag SpA
12:20 – 12:40
Impact of COVID-19 on Clinical Trials. New approaches that can be taken for future trials
Martine Dehlinger-Kremer, EUCROF
12:40 – 13:00
Academia perspective
Andrea Gambotto, University of Pittsburgh School of Medicine
13:00 – 13:10
Q&A session
13:10 – 14:00
Break
Session 3 – Special insights on pharmaceutical R&D plans and rules in the framework of the pharmaceutical system reform
Chairs Fabio D’Atri & Paola Baiardi
14:00 – 14:30
Orphan Medicines Regulation faced with changes in EU and US pharmaceutical perspective
Viviana Giannuzzi, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Discussant: Violeta Stoyanova-Beninska, Committee for Orphan Medicinal Products at EMA
14:30 – 15:00
Strategic considerations regarding paediatric medicine development – Enpr-EMA reflections
Pirkko Lepola, European Network of Paediatric Research at the European Medicines Agency
Discussant: Donato Bonifazi, European Paediatric Translational Research Infrastructure – EPTRI
15:00 – 15:30
Research and innovation for new and advanced medicines: the role of Artificial Intelligence
Francesca Mazzi, Queen Mary University of London
Discussant: Fedele Bonifazi, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
15:30 – 15:50
Ethical concerns and risks in health emergency: patients protection and fundamental rights
Annagrazia Altavilla, Espace Ethique PACA-Corse/AP-HM
15:50 – 16:10
Discussion and final remarks
Speakers' list
Download the speakers’ list here.
Highlights
Highlights are brief reports that refer the key points of the topics discussed by each speaker.
Session I
- The new Pharmaceutical Strategy for Europe – Timely patient access to affordable medicines: key points and challenges – Fabio D’Atri
- The increased value of the EC consultation to promote the new strategy – Viviana Giannuzzi & Enrico Bosone
- Patients’ perspective – François Houyez
Session II
- Company perspective – Martin F. Ryser
- Impact of COVID-19 on Clinical Trials. New approaches that can be taken for future trials – Martine Dehlinger-Kremer
Session III
- Orphan Medicines Regulation faced with changes in EU and US pharmaceutical perspective – Viviana Giannuzzi (Discussant: Violeta Stoyanova-Beninska)
- Research and innovation for new and advanced medicines: the role of Artificial Intelligence – Francesca Mazzi (Discussant: Fedele Bonifazi)
- Ethical concerns and risks in health emergency: patients protection and fundamental rights – Annagrazia Altavilla (Discussant: Marek Migdal)
Please fill the form below to access to the material including speaker’s presentations shared during the webinar and recordings.
You can support our activities, including also the organisation of the Foresight Training Course, with a voluntary contribution that will help us keeping on our commitment and involvment in the research field. Even a small contribution can make the difference. Thank you!
Course Scientific Committee
Adriana Ceci | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Enrico Bosone | Società Italiana Attività Regolatorie
Fedele Bonifazi | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Salvatore Vincenzo | Università di Insubria
Annagrazia Altavilla | Espace Ethique PACA-Corse/AP-HM
Viviana Giannuzzi | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
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