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Will The New EU Pharmacovigilance Legislation Fulfil Its Purpose? 24-25 January 2013, Madrid

With the aim of improving the protection of public health, the EU has redefined the practice of with new legislation that took effect in July 2012.

Better protection of patients by strengthening the EU pharmacovigilance system, enabling citizens to get high-quality information on medicines, and tackling the growing issues of counterfeiting and illegal distribution of medications were said to be the main objectives that stood behind the emergence of the new legislation. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introducing the concept of a pharmacovigilance system master file have been redefined.

Now more than two months have passed since seven modules of the guideline on good pharmacovigilance practices, covering one major process in the safety monitoring of medicines each, came into effect on Monday, 2 July 2012.

Where lie the main differences? What has already changed and whom will these changes help? Will the new EU Pharmacovigilance legislation fulfil its purpose and improve the protection of public health? What “price” will companies need to pay in order to achieve this objective?

Leading professionals from pharma companies such as GSK, Novartis, Sanofi, BMS, Eisai, Novo Nordisk and regulatory bodies from Denmark, Netherlands and Spain will answer all of your questions at ’s 3rd Annual Pharmacovigilance and Risk Management Strategies conference.

EU Qualified Person for from , one of more than 60 attendees, revealed upon his return from the past PV meeting “I specifically liked the smaller size of the audience which enhanced possibilities for interactive discussions and networking.” And the 2013 event plans to raise it even higher!

Gathering on 24 – 25 January 2013 in the capital of Spain, Madrid, expert minds from industry, regulatory authorities and government will further examine all pharmacovigilance areas of recent concern.

Mr. Philippe Close, Chief Safety Officer and EU/EEA QPPV, Novartis Pharma AG, Switzerland, will introduce an industry perspective on Linking signal detection, risk management and qualitative B-R analysis.

Regulatory insights into Decision-making processes in Pharmacovigilance (the role of the PRAC and its interaction with CHMP and CMDh) will be presented by Ms. from the Spanish Agency of Medicines and Medical Devices (AEMPS).

If you want to be up-to-date with the latest developments in pharmacovigilance area, join our Pharma Quality, Safety & Supply Chain Forum.


About Fleming Europe

Established in Slovakia, Fleming Europe represents a Pan-European B2B networking channel for specialists to collect & share knowledge. Since 2004, the company has been encouraging decision makers to share their experiences through market leading conferences, trainings and webinars. The annual audience of 10,000 Banking, Defense, Energy, Oil & Gas, Pharma, Telco and Transport peers benefit from insights on industry trends when applying them to their own business practices.

For more information visit http://www.flemingeurope.com