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IMPLEMENTATION OF CORRECTIVE ACTION PLANS. Karen Lowney Senior Director, Global Compliance Cephalon Elizabeth A. Lewis Vice President, Deputy General Counsel Millennium Pharmaceuticals, the Takeda Oncology Company Wendy C. Goldstein (Moderator) Shareholder

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implementation of corrective action plans

IMPLEMENTATION OF CORRECTIVE ACTION PLANS

Karen Lowney

Senior Director, Global Compliance

Cephalon

Elizabeth A. Lewis

Vice President, Deputy General Counsel

Millennium Pharmaceuticals, the Takeda Oncology Company

Wendy C. Goldstein (Moderator)

Shareholder

Epstein Becker & Green, P.C.

OCTOBER 2008

slide2

DISCLAIMER

The Statements Made By the Panelists during this Session Represent His/Her Individual Views and Should Not Be Construed to Represent those of his/her organization.

implementation

1

IMPLEMENTATION

Audience Polling Question

Fill in the Blank:

In your opinion, ________ is the biggest challenge when implementing a corrective action plan approved as part of the resolution of an investigation.

implementation1

2

IMPLEMENTATION

Audience Polling Question

In your opinion, _______ of the CAPs that are approved as part of the resolutions of investigations are completed in their entirety.

All

More than 75%

Between 50% - 75%

Less than 50%

implementation2

3

IMPLEMENTATION

Audience Polling Question

In your opinion, who should be responsible for ensuring that the CAP approved as part of the resolution of an investigation is completed?

Compliance department

Legal department

Human Resources

Business

implementation3

4

IMPLEMENTATION

Audience Polling Question

True or False:

There are never attorney-client privilege considerations when implementing a CAP.

True

False

implementation4

5

IMPLEMENTATION

Audience Polling Question

In your opinion, in which location(s) should records relating to the implementation and completion of the CAP be maintained?

Compliance department

Legal department

Human Resources

Business

Other

implementation of corrective action plans1

IMPLEMENTATION OF CORRECTIVE ACTION PLANS

Karen Lowney

Senior Director, Global Compliance

Cephalon

Elizabeth A. Lewis

Vice President, Deputy General Counsel

Millennium Pharmaceuticals, the Takeda Oncology Company

Wendy C. Goldstein (Moderator)

Shareholder

Epstein Becker & Green, P.C.

OCTOBER 2008