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.
The agenda will be updated soon! Stay tuned!
Instructions to register and join the event:
Register for free for the course by clicking on the button below. Feel free to share the link among your contacts. After the registration, you will receive a confirmation email from GoToWebinar system including a unique link to join that is strictly personal so please do not share it. You can dial in by phone using the phone numbers including in the confirmation email. Do not hesitate to contact us at: firstname.lastname@example.org for any support.
Here you can download a useful guide for attendees!
09:30 – 09:50 Keynote address
Session 1 – The COVID-19 emergency and the European pharmaceutical system: strengths and weaknesses
09:50 – 10:10 Pharmaceutical Strategy for Europe
10:10 – 10:30 EMA strategy: how COVID-19 pandemic has changed the regulatory framework for timely approval of new and innovative drugs and vaccines
10:30 – 10:50 Action plan for affordable and accessible medicines for European citizens
10:50 – 11:50 Roundtable:
10:50 – 11:10 Company perspective
11:10 – 11:30 Patients perspective
11:30 – 11:50 Healthcare system perspective
11:50 – 12:10 COVID-19 accelerates research and development of new vaccines: academia perspective
12:10 – 12:30 COVID-19 accelerates research and development of new vaccines: company perspective
12:30 – 14:00 Break
Session 2 – Special insights on pharmaceutical R&D plans and rules in the framework of the pharmaceutical system reform
14:00 – 14:25 The key points of the survey on the Pharmaceutical Strategy – Timely patient access to affordable medicines
14:25 – 14:50 Orphan Medicines Regulation faced with changes in EU and US pharmaceutical perspective
14:50 – 15:15 Safe and accessible medicine for children: how to change the Paediatric Regulation
15:15 – 15:40 Research and innovation for new and advanced medicines: the role of Artificial Intelligence
15:40 – 16:05 Ethical concerns and risks in health emergency: patients protection and fundamental rights
16:05 – 16:30 Discussion and final remarks
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