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Ema'S ANTI-FRAUD STRATEGy

Ema'S ANTI-FRAUD STRATEGy. KENZA BEN YAHIA  –  MASTER 2 AREIPS . table of contents  I. What is fraud ?   II. regulatory history  iii. EMA'S ANTI-FRAUD STRATEGY ( nOVEMBER 2014 ). WHAT IS FRAUD ? . Intentional  breach of a rule . Financial interests. Obtaining a GAIN. European Union .

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Ema'S ANTI-FRAUD STRATEGy

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  1. Ema'S ANTI-FRAUD STRATEGy KENZA BEN YAHIA  –  MASTER 2 AREIPS 

  2. table of contents  I. What is fraud ?  II. regulatory history iii. EMA'S ANTI-FRAUD STRATEGY ( nOVEMBER 2014 )

  3. WHAT IS FRAUD ?  Intentional breach of a rule  Financial interests Obtaining a GAIN European Union  Misebehaviours  Reputational impact Favouritism & collusion

  4. REGULATORY HISTORY 

  5. 1 Enteredinto force on 1stJune 1999 16  Articles ''  Regulation1073/1999 of the European Union Parliament and of the Council of 25 May 1999 conducted by the EuropeanAnti-Fraud Office '' Full independance to exerciseitsinvestigative fonction Responsabilityfor conducting administrative investigations 

  6. 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 '' Decision " to cooperate with the OLAF " Tookeffect on 1st June 1999

  7. Key elements which gave birth to EMA's anti-fraud strategy

  8. 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

  9. The Anti-FraudStrategy (November 2014) programm Fraud Risk-assessment Strategic Objectives Zero tolerance approach ALL STAGES OF THE ANTI-FRAUD CYCLE  4 AREAS OF RISK - Data security / theft - Impartiallity of assessment - Procurement  - Recruitment - Prevention                              - Recovery - Detection                              - Sanction - Investigation 

  10. 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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