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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

Date

15 - 16 June 2020

Location

Milan

Language

Italian

EudraVigilance, EVDAS and MLM service

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
Francesco Tescione European Qualified Person Responsible for Pharmacovigilance - L.Molteni & C. dei F.lli Alitti

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.


Participant experience 

The training is recommended for those who know the Good Pharmacovigilance Practices (GVP) reference (Form VI, V and IX) and having at least 1 year of pharmacovigilance experience.

Note: A laptop with MS Office installed is needed for the practical activity.

  • Lecturer presentation
  • Contents discussion
  • Comparison and sharing of experiences among participants
  • eRMR practical exercise  

Hotel Melià
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.


Upon Arrival
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.

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.



Training Room

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.



Teaching materials

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.

Fee includes
Tuition, teaching materials, lunch and coffee breaks, organizational office assistance, attendance certificate. 

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.
Brochure
Certificate of attendance

Early Bird: € 1.180,00* (until 25 May 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.

Register now

Course Price

1390.00 €

Early Bird

Monday, May 25, 2020

1180.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

1,5 days

Course Type

Limited number of participants

You will receive

Certificate of attendance

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

Participants' Feedbacks

Teacher was very clear  and outstanding  knowledge of the contents 

Only positive: very expert presenters in this field, very good discussion at high level

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EudraVigilance, EVDAS and MLM service

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, following this link.