Discover the course
EudraVigilance, EVDAS and MLM service
Training on the EudraVigilance system focusing on EVDAS (EudraVigilance Data Analysis System) and MLM (Medical Literature Monitoring): critical aspects, challenges, and opportunities
EudraVigilance is the main European network for the development, management and scientific evaluation of pharmacovigilance reports, used by Competent Authority, Marketing Authorization Holders and clinical trials promoters to collect and submit safety information on drugs marketed in Europe.
The EudraVigilance system has been strengthened to include the adverse reactions monitoring from scientific publications MLM (Medical Literature Monitoring) and the use of EVDAS (Eudravigilance Data Analysis System) for data analysis and Signal Detection. EudraVigilance is, thus, a fundamental tool to evaluate the risk assessment of drugs marketed in Europe.
The training course will cover the following aspects:
- management and procedural aspects for suspected adverse drug reactions reporting
- new EudraVigilance system implemented steps
- use of EVDAS for Signal Detection and Signal Validation
- registration process to the EMA portal
- EudraVigilance access policy
- updates on the IT systems necessary for the correct development of any pharmacovigilance system
Interactive discussion with participants will be an integral part of the training course, focusing on the complexities experienced in the daily activity to identify possible solutions and the practical implementation of the new EudraVigilance system in different companies.
The training will be completed by practical exercise on Signal Detection using the eRMR lists (Reaction Monitoring Report), the participants will be able to verify their ability to apply the concepts discussed consequently.
Francesco Tescione is European Qualified Person Responsible for Pharmacovigilance, L.Molteni & C. dei F.lli Alitti. He coordinates and is responsible for all pharmacovigilance system aspects, including those of quality and risk management. He graduated in Pharmacy at the Salerno University and has held the Eu-QPPV position for more than 10 years, many of which were spent abroad. He has published several articles in international journals dealing with topics such as the predictability of adverse reactions and methods to determining cause-effect relationships. He participated as speaker in more conferences on new EudraVigilance system aspects.
- Qualified Person for Pharmacovigilance (QPPV)
- Pharmacovigilance Managers
- EudraVigilance Users
- Pharmacovigilance Auditor
belonging to: Pharmaceutical Companies, Service Providers (CRO, CSO, consultants), Biotech Companies.
- Lecturer presentation
- Contents discussion
- Comparison and sharing of experiences among participants
- eRMR practical exercise
Via Masaccio 19
20149 – Milano
Melia Milano is perfectly located in the most dynamic and fastest-growing district in Milan, a short walk from CityLife, a new architectural project with a shopping centre and urban garden. The historical city centre of Milan is just 15 minutes away using the nearby subway.
2 minutes walking from the metro station Lotto (M1 red line or M5 violet line)
Milan Linate airport, 12 km from Hotel Melià, is the most closest airport to the city and can be easily reached by car, bus or train
Central Station 6 km, Cadorna Station 3,5 km, Garibaldi Station 4 km
Garage Masaccio (30 mt), Garage Lotto (350 mt), Parcheggio San Siro (300 mt)
In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
Hotel Oro Blu (at 230 mt)
Hotel Portello (at 450 mt)
Hotel Montebianco (at 270 mt)
Ristorante Pizzeria La Primula, Via Spagnoletto, 19 (11 minutes by walking). Or, in 15 minutes by metro you can reach the historic city center (“Duomo” metro stop) with various restaurants.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 1.180,00* (until 19 February 2020)
Ordinary: € 1.390,00*
Freelance - Academy - Public Administration**: € 700,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Wednesday, February 19, 2020
At the end of the training, you will be able to
Fully understand the procedural aspects of the screening and management of reports from EudraVigilance and EMA MLM
Arrange the innovations introduced by the ICH E2B (R3), GVP Forms VI and IX
Understand how EVDAS and eRMRs should be used for Signal Detection and Signal Validation
Understand the processes/activities/documentation that needs to be reviewed and how to set up its logistics accordingly
Understand how the signal management processes, pharmacovigilance signals and security risks are interconnected
Learn practical tips to be used on a daily basis