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ONLINE TRAINING: 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 online 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.
This online training is divided in 3 modules:
- Module 1 | 29th September from 2.30 pm to 5.30 pm
- Module 2 | 1st October from 2.30 pm to 5.30 pm
- Module 3 | 5th October from 2.30 pm to 5.30 pm
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 990,00* until 08/09/2020
Ordinary: € 1.180,00*
Freelance - Academy - Public Administration**: €595,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: Access to the online training, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.
Tuesday, September 8, 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