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How to Grow a How to Grow a  Compliance OfficerCompliance Officer1414thth

Annual Pharmaceutical Regulatory and Annual Pharmaceutical Regulatory and Compliance Congress Compliance Congress ––

October 29October 29thth, 2013, 2013

Maxine Nogard, Biogen IdecMary Bennett, R.Ph. –

NAVEX GlobalDonna Phelps, CHC-

Cornerstone Compliance Group

{{ {{Maxine NogardMaxine Nogard Donna Phelps, Donna Phelps, CHCCHC

President, President, Cornerstone Compliance Group, LLCCornerstone Compliance Group, LLC

Who We AreWho We Are

{ Mary Bennett, Mary Bennett, R.Ph.R.Ph.

Vice President, Vice President, Advisory ServicesAdvisory Services

NAVEX Global NAVEX Global

Senior Director, Senior Director, Global Corporate ComplianceGlobal Corporate ComplianceBiogen IdecBiogen Idec

To move people with institutional knowledge To move people with institutional knowledge smoothly into smoothly into compliance rolescompliance roles

To establish To establish common knowledge base common knowledge base for for compliance professionals in your organizationcompliance professionals in your organization

To ready staff for To ready staff for further advancement further advancement within the compliance organizationwithin the compliance organization

Why Invest in Compliance Why Invest in Compliance  Officer Development?Officer Development?

{{ {{Traditional ModelTraditional Model

Boot campBoot campUse your own staff Use your own staff for development and for development and deliverydeliveryNo meshing of flow No meshing of flow from start to finishfrom start to finishPartial attendance Partial attendance okay for participantsokay for participants

New ModelNew Model

AcademyAcademyCombine internal and Combine internal and external resources for external resources for development and development and deliverydeliveryInstructional design Instructional design that builds on previous that builds on previous conceptsconceptsParticipants Participants ““all inall in”” or or outout

Breaking the MoldBreaking the Mold

Once in a pharma company Once in a pharma company  not so far awaynot so far away……

{{

A weekA week--long experiential long experiential academyacademy

Highly interactiveHighly interactive

Include content on 7 Steps, Include content on 7 Steps, soft skills, companysoft skills, company’’s s approach, expectationsapproach, expectations

Formal postFormal post--testing of testing of knowledge and skillsknowledge and skills

Buy or build discussionBuy or build discussion

The Business CaseThe Business Case

“This was the best training I have ever had, in any subject,during my entire career.” -

Academy Participant

International + US attendeesInternational + US attendees

Onsite v. offsiteOnsite v. offsite

BudgetBudget

Setting expectations for Setting expectations for attendees, faculty, and seniorattendees, faculty, and seniorleadershipleadership

Issues and HurdlesIssues and Hurdles

Academy ToolsAnnotated Facilitator Guide

{{ {{Wall PostersWall PostersLightening RoundsLightening RoundsPolling QuestionsPolling QuestionsCase StudiesCase StudiesSmall Group ActivitiesSmall Group ActivitiesLarge Group ActivitiesLarge Group Activities

Tools for LearningTools for Learning

{{ {{Learning GamesLearning Games Toys & TreatsToys & Treats

Tools for Learning Tools for Learning 

Tools for LearningTools for Learning

Polling TechnologyPolling Technology

AgendaAgenda

Tuesday Module 4: Biogen Idec Global SOPs SOP WORLD CUP COMPETITIONLUNCH N’

LEARN: MSL EffectivenessModule 5: Conversing with Impact  

Thursday Final Assessment: Written Exam & Role Plays

LUNCH  N’

LEARN: Market Research ACTIVITIES:ACO group photo  Review of Your ACO ResponsibilitiesRECOGNITION: Awards and certificatesFinal Thoughts & Adjourn

Blind SpotsBlind Spots, Bazerman & Tenbrunsel, , Bazerman & Tenbrunsel, Princeton University Press, 2011Princeton University Press, 2011

Walmart case study Walmart case study

Biogen Idec SOPsBiogen Idec SOPs

PrePre‐‐ReadingReading

{{

Gifts, Hospitality, and Event Related CostsGifts, Hospitality, and Event Related Costs

{{

Gifts, Hospitality & Event Gifts, Hospitality & Event  Related CostsRelated Costs

{{““We never get soft skills We never get soft skills training in compliance so training in compliance so this was especially great this was especially great to learn!to learn!””--

Academy ParticipantAcademy Participant

Soft Skills ModuleSoft Skills Module

Education about Effective Interactions with Education about Effective Interactions with  Business LeadershipBusiness Leadership

10 Things Every Business Manager Should Ask A 10 Things Every Business Manager Should Ask A Compliance OfficerCompliance Officer

1.1.

What activities in this business unit put the company at the greWhat activities in this business unit put the company at the greatest atest riskrisk??2.2.

Do we have the correct Do we have the correct policies and procedures policies and procedures in place to help in place to help mitigate those risks?mitigate those risks?

3.3.

Are those policies and procedures being Are those policies and procedures being followedfollowed? ? 4.4.

How is the most effective How is the most effective trainingtraining for the business unit being for the business unit being conducted?conducted?

5.5.

Is the business Is the business supportivesupportive of your training efforts?of your training efforts?6.6.

How are you How are you monitoringmonitoring for the highest risks?for the highest risks?7.7.

What are your findings from the monitoring?What are your findings from the monitoring?8.8.

What can the business do to help ensure that monitoring What can the business do to help ensure that monitoring issues are issues are addressed?addressed?

9.9.

Are you being Are you being brought into discussions brought into discussions early in the process by the early in the process by the business?business?

10.10.

Do you have access to the Do you have access to the right people and resources right people and resources in the affiliate to in the affiliate to do your job most effectively?do your job most effectively?

Role PlayRole Play

The Affiliate in India is preparing for a product launch and The Affiliate in India is preparing for a product launch and wants to engage a consultant from the US, an HCP from wants to engage a consultant from the US, an HCP from Massachusetts. The newly appointed Medical Director in Massachusetts. The newly appointed Medical Director in India decides to avoid a lot of organizational India decides to avoid a lot of organizational bureaucracybureaucracy……and telephones the US physician directly to and telephones the US physician directly to make arrangements.make arrangements.

−

What is your confidence level that the US Transparency Office will know about this?

−

Is this payment reportable? Travel/hotel/meals?−

What do the Compliance Officers in the involved countries need to know?−

What needs to be communicated?−

What remediation, if any, do you recommend?

Small Group Activity

The GraduatesThe Graduates

{{“…“… Three of us, with more Three of us, with more than 60 collective years of than 60 collective years of E&C experience, are E&C experience, are envious of envious of ……[your] [your] compliance officers who compliance officers who will complete this will complete this program..program..””----

Keith Darcy, ECOAKeith Darcy, ECOA

ECOA EndorsementECOA Endorsement

What is the most important skill/knowledge you What is the most important skill/knowledge you learned?learned?How have you been able to apply the How have you been able to apply the information learned at the Academy in your day information learned at the Academy in your day to day activities?to day activities?What modules/topics were most helpful? What modules/topics were most helpful? 

Participant Survey ResultsParticipant Survey Results

“My overall knowledge as a 

Compliance Manager significantly 

increased…”

“The training provided me with the 

structure and strategy to prepare 

for difficult conversations…” “Role plays were enormously 

helpful…”

“The mix of modules was helpful in 

different ways .Some built fact 

knowledge. Others  helped me with 

behavior and interactions…”

Academy TimelineAcademy Timeline

Q&A PanelQ&A Panel