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Benelux Pharmacovigilance Day

Pharmacovigilance challenges: Hot Topics in 2017

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Who should attend?

This one-day conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care system dealing with the Pharmacovigilance system, such as: Pharmacovigilance dept., Clinical operation dept., Statistic dept., Medical Affairs dept., Regulatory Affairs dept. and Quality & Compliance dept. in pharmaceutical and Biotech companies, Clinical Research Organizations (CROs) and publich health centers.

Details

Pharmacovigilance started in 1961, and since then a lot has changed. Traditionally, spontaneous reporting of adverse drug reactions by health care professionals to the regulatory authorities is the cornerstone of pharmacovigilance systems. However, due to underreporting and some important safety incidents in the previous decade, pharmacovigilance environment is changing rapidly.

Increasing attention of regulatory authorities for PV resulted in the previous in the GVP-modules for Pharmacovigilance, guidelines for Veterinary Pharmacovigilance and the revision of guidelines for medical device reporting. In addition to spontaneous reporting by health care professionals, patient reporting, digital media reporting, electronic health records, scientific literature and real world data are becoming more and more important. Marketing authorisation holders need to process an increasing amount of data, often with limited resources, which increases the tendency to outsource pharmacovigilance activities. Therefore, Pharmacovigilance today is not just about collecting adverse drug reactions, it is also about organizing data and processes in an efficient manner with an increasing focus on software solutions, vendor management and quality performance. This is also reflected in the upcoming changes of the EudraVigilance system, the implementation of the ICH-E2B (R3) format, the MAHs’ access to EudraVigilance with regard to the EV Database Warehouse and Analysis System (EVDAS) and data output in form of an electronic Reaction Monitoring Report (eRMR).

All these changes have major impact on Marketing Authorisation’s current PV system, and during the Pharmacovigilance Benelux Day discussion will focus on these Hot Topics:

• Reporting Adverse Drug Reactions via Digital Media
• Implementation of the ICH-E2B (R3) Format for ICSRs
• Measuring effectiveness of Risk Minimisation 
• And many other topics

The Scientific Board:

Joyce de LangenSenior Solution Manager Pharmacovigilance at Elsevier

Prices

REGISTRATION FEE: euro 595,00 Early Bird fee until September 15th, 2017; euro 710,00 Ordinary fee (after September 15th, 2017); euro 540,00 Patronage members fee; euro 390,00 for Academy, Public Administration, Freelance. 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.

Contact

Stefania Sarga
stefania.sarga@lsacademy.it

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