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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