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Ema'S ANTI-FRAUD STRATEGy
KENZA BEN YAHIA – MASTER 2 AREIPS
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table of contents I. What is fraud. II. regulatory history iii
table of contents I. What is fraud ? II. regulatory history iii. EMA'S ANTI-FRAUD STRATEGY ( nOVEMBER 2014 )
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Intentional breach of a rule Favouritism & collusion
WHAT IS FRAUD ? Intentional breach of a rule Financial interests Obtaining a GAIN European Union Misebehaviours Reputational impact Favouritism & collusion
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REGULATORY HISTORY
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1 Entered into force on 1st June 1999 16 Articles
16 Articles '' Regulation1073/1999 of the European Union Parliament and of the Council of 25 May 1999 conducted by the European Anti-Fraud Office '' Responsability for conducting administrative investigations Full independance to exercise its investigative fonction
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'' No further action taken '' Decision " to cooperate with the OLAF "
2 " Decision of the European Agency for the evaluation of Medicinal Products of 1st June 1999 concerning the terms and conditions for internal investigations in relation to the prevention of fraud […] " 7 Articles Supply information Assistance '' No further action taken '' Took effect on 1st June 1999 Decision " to cooperate with the OLAF "
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Key elements which gave birth to EMA's anti-fraud strategy
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Article 69 of Regulation 726/2004
Objective Spreading Article 69 of Regulation 726/2004 Agreement of July 2012 & Article 325 TFEU COMBACT FRAUD ALL EU AGENCIES > > 1073/1999 " shall apply without restriction " & > EMA " shall issue without delay all provisions applicable to all the employees " Anti-Fraud measures
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The Anti-Fraud Strategy (November 2014) programm
Fraud Risk-assessment Strategic Objectives Zero tolerance approach 4 AREAS OF RISK ALL STAGES OF THE ANTI-FRAUD CYCLE - Data security / theft - Impartiallity of assessment - Procurement - Recruitment - Prevention - Recovery - Detection - Sanction - Investigation
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Focus effort on fraud-risk mitigation
Develop an anti-fraud culture Goals Develop fraud prevention, detection, reporting, monitoring and handling-capacity Develop prevention and detection of favouritism
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