If you missed our seminar on clinical trials on January 16, here are five key takeaways to help you understand the changing regulatory environment in Europe and Italy.
- Be ready for a new regulatory landscape
The recent clinical trials regulatory overhaul within the EU aims at fostering research and facilitating the tasks of all actors involved in this area. However, delays in the implementation of such new legislation are posing an actual risk for the entire sector throughout the EU, while competition from emerging economies is getting stronger.
- Harmonized, but not enough
In several areas, such as observational studies or ethical committee’s assessments, a unified approach at European level is yet to be adopted. This leaves a lot of fragmentation among the various countries and a lot of work to be done at local level in order to ensure compliance with applicable regulations. Be prepared to deal with such inconveniences, in particular in the pharmaceutical sector.
- Changes in data protection laws offer new opportunities but challenges remain
GDPR brought new harmonized provisions to improve and support the use of data for the purpose of conducting research. However, guidance from national data protection and regulatory authorities in areas such as legal grounds for processing and secondary use is far from established. Moreover, different EU countries continue to adopt opposite approaches when it comes to consent and legitimate interest as valid legal grounds for data processing in the framework of clinical research. Data protection compliance will therefore continue to require local check-ups.
- New opportunities for independent research
Recent regulatory changes in Italy are being implemented to foster independent not-for-profit research in the clinical area. The new regulations, which are about to be adopted, envisage new opportunities for the participation of private actors in independent research and allow not-for-profit research institutions to better exploit the results of their research. The potential for conflicts remain and caution should be exercised within public-private relationships, but there is hope that new paradigms of collaboration will see the light.
- A new world of evidence is out there
More and more projects in the clinical research field involve real world data and real world evidence, gathered in a number of different ways outside the rigid protocols of a controlled study, whether through medical devices or other data collection instruments. Real world data are key to understanding how treatments work in reality and developing new healthcare paths. However, both clinicians and private actors are operating in uncharted territories and the line between studies and alternative research projects is thinner than you may expect. Be mindful of the regulatory and compliance ramifications of these new powerful tools.
On January 16 our firm Gitti and Partners will be hosting a seminar on clinical trials legislation and its related opportunities and risks. The seminar will look at drug trials and medical devices investigations from various angles, including regulatory, data processing and criminal law perspectives.
Ms. Alice Cabrio and Ms. Giulia Corti, Corporate & Compliance Managers at Roche S.p.A., will focus on the challenges of reconciling GDPR and trials.
Dr. Eleonora Ferretti will bring the perspective of the trial unit of a large public hospital that is also a research center.
Ms. Elisa Tacconi and Ms. Elisa Corleto of Medtronic Italia S.p.A. will dive into real world evidence and will explore the limits of trials’ regulations.
Our Fabrizio Sardella and Ms. Castagno and Mr. Stigliano of Orrick will highlight criminal risks linked to clinical trials.
The seminar promises to be very interesting and you are welcome to join us.
The full program can be found here: http://grplex.com/en/conferences/download/765/clinical-trials–risks-and-opportunities-in-a-new-regulatory-environment
On November 5 and 6 the G7 Ministerial Meeting on Health was held in Milan. The meeting had an ambitious agenda, ranging from the impact of climate change on people’s health to antibiotic resistance.
According to the Italian Ministry of Health, hosting the summit on the occasion of the 2017 Italian G7 presidency, the meeting innovated in the way matters have been examined and discussed, by using a so called Delphi method based on the opinions of the world’s leading experts.
A number of satellite events have also taken place across the city, including a conference organized by police forces to address the cross-border fight against “pharmaceutical crime” in all its forms, identifying the critical factors and common responses. The conference focused on the strategies and international collaborations needed to crack down on counterfeit pharmaceutical products, as well as the import and on-line sales of unauthorized products.
Another satellite event focused on the employment of new technologies in the healthcare sector, with particular emphasis on sustainability. Antibiotic resistance has also been a key item on the agenda. Italy is among the countries in the world where deaths linked to antibiotic resistance are higher.
Italian authorities did not conceal that one of the hidden goals of the summit was for them to lobby for the relocation of the European Medicines Agency- EMA headquarters to Milan. The political battle among candidate cities is about to get more intense, as a decision is expected to be adopted before the end of November.
More information on the agenda and materials of the summit can be found here: http://www.g7italy.it/en.
For more information on the event and registration process please click here.
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The next event of Health Innovation Academy will take place on February 19, 2015 in Milan.
We will discuss how technological innovation reaches patients, with a focus on medical devices within the Lombardy healthcare system.
For more information on the event: http://healthinnovationacademy.weebly.com/come-giunge-linnovazione-tecnologica-al-paziente.html