7th Annual
Pharmaceutical Law Conference
Achieving Business
Conduct Compliance
through Auditing
Dr Simone Mitchell – DLA P...
Agenda
1. The need for compliance audits
2. Preparing the business for an audit
3. Conducting the audit
4. What do you do ...
1. Why is it important to
audit?
1. Why is it important to audit?
30 May 2014 4Achieving Business Conduct Compliance through Auditing
1. Why is it important to audit?
Pharmaceutical
Industry
Medicines
Australia
Code of
Conduct
Australian
Consumer
Law
Priva...
1. Why is it important to audit?
Areas of concern:
• Interactions with HCPs
• Interactions with consumers
• Interactions w...
1. Why is it important to audit?
What are the benefits?
 Identify potential risk exposures
 Anticipate and prevent issue...
2. Preparing the business
for an audit
2. Preparing the business for an audit
Identify areas of risk to be evaluated as part of the audit by
considering:
 inter...
2. Preparing the business for an audit
Planning
1. Obtain buy-in for the methodology
2. Conduct kick off meetings will all...
3. Conducting the audit
3. Conducting an audit
Paper Audit Interviews Reporting Implementation
Date of presentationInsert filename here 12
3. Conducting an audit
Paper Audit
 Locate policies and other
control documents
 Identify other documents/
sources of in...
3. Conducting an audit
Interviews
 Determine who you will
interview
 Order of interviews can be
important
 Develop inte...
4. What to do with the
results?
4. What to do with the results?
Speaker Programs
Policy • Speaker program policy exists but has not been
socialised across...
4. What to do with the results?
Identify issue Assess &
triage issue
Implement
follow
up/corrective
action
Evaluate
correc...
4. What to do with the results?
Corrective action plan
 Define who owns the plan
and ensure that it is properly
documente...
What to do with the results?
 Link behaviours to incentive
compensation models
 Retrain staff
 Monitor
 Hold superviso...
Contact details
Simone Mitchell
Partner
DLA Piper
T. 02 9286 8484
simone.mitchell@dlapiper.com
30 May 2014 20
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Simone Mitchell, DLA Piper - Achieving Business Conduct compliance through Auditing

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Simone Mitchell delivered the presentation at 2014 Pharmaceutical Law Conference.

The Pharmaceutical Law Conference is the foremost meeting place and networking hub of the pharmaceutical law industry, and the only pharmaceutical law event in the Asia-Pacific region. The 2014 event highlights included pharma law reform, IP, competitive strategies, industry transparency, sustainable drug pricing and patenting life sciences and more.

For more information about the event, please visit: http://www.informa.com.au/pharmalawevent14

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Simone Mitchell, DLA Piper - Achieving Business Conduct compliance through Auditing

  1. 1. 7th Annual Pharmaceutical Law Conference Achieving Business Conduct Compliance through Auditing Dr Simone Mitchell – DLA Piper Australia Sydney Harbour Mariott Friday 30 May 2014
  2. 2. Agenda 1. The need for compliance audits 2. Preparing the business for an audit 3. Conducting the audit 4. What do you do with the results? 5. Questions 30 May 2014Achieving Business Conduct Compliance through Auditing 2
  3. 3. 1. Why is it important to audit?
  4. 4. 1. Why is it important to audit? 30 May 2014 4Achieving Business Conduct Compliance through Auditing
  5. 5. 1. Why is it important to audit? Pharmaceutical Industry Medicines Australia Code of Conduct Australian Consumer Law Privacy Act 1988 (Cth) Anti-Money Laundering/F CPA Internal policies and procedures Therapeutic Goods Administratio n policies and procedures 30 May 2014 5Achieving Business Conduct Compliance through Auditing
  6. 6. 1. Why is it important to audit? Areas of concern: • Interactions with HCPs • Interactions with consumers • Interactions with wholesalers • Interactions with advocacy groups • Relationships with distributors • Charitable contributions • Involvement in industry bodies Date of presentationInsert filename here 6
  7. 7. 1. Why is it important to audit? What are the benefits?  Identify potential risk exposures  Anticipate and prevent issues before they arise  Should result in increased awareness by employees and contractors of the obligations and requirements imposed by law, policies and procedures.  Provide insight to allocating limited resources Date of presentationInsert filename here 7
  8. 8. 2. Preparing the business for an audit
  9. 9. 2. Preparing the business for an audit Identify areas of risk to be evaluated as part of the audit by considering:  internal and external risk factors  previous audits and monitoring programmes  known issues  training  volume of transactions/annual expenditure  level of processes and controls  responsibility 30 May 2014 9Achieving Business Conduct Compliance through Auditing
  10. 10. 2. Preparing the business for an audit Planning 1. Obtain buy-in for the methodology 2. Conduct kick off meetings will all interviewees and related parties 3. Schedule status updates to all stakeholders Date of presentationInsert filename here 10
  11. 11. 3. Conducting the audit
  12. 12. 3. Conducting an audit Paper Audit Interviews Reporting Implementation Date of presentationInsert filename here 12
  13. 13. 3. Conducting an audit Paper Audit  Locate policies and other control documents  Identify other documents/ sources of information  Sampling can be random targeted, such as based on geography, products, sales, performance issues, previous compliance violations 30 May 2014 13Achieving Business Conduct Compliance through Auditing
  14. 14. 3. Conducting an audit Interviews  Determine who you will interview  Order of interviews can be important  Develop interview guidelines  Plan questions but be prepared to be flexible  Allocate enough time Date of presentationInsert filename here 14
  15. 15. 4. What to do with the results?
  16. 16. 4. What to do with the results? Speaker Programs Policy • Speaker program policy exists but has not been socialised across the organisation Process • Procedural documents are in DRAFT form and have not been finalised Documentation/Tools • Control documentation is not being used as directed Audit • No prior audits Monitoring • Field monitoring via a well developed plan – reach limited by manpower constraints Issues • Issues with awareness and understanding of policy and procedures Training • Speaker training occurs regularly but internal training is mainly for new employees only Dept. involved • Many Date of presentationInsert filename here 16
  17. 17. 4. What to do with the results? Identify issue Assess & triage issue Implement follow up/corrective action Evaluate corrective action & related results 30 May 2014 17Achieving Business Conduct Compliance through Auditing
  18. 18. 4. What to do with the results? Corrective action plan  Define who owns the plan and ensure that it is properly documented  Communicate to business Date of presentationInsert filename here 18
  19. 19. What to do with the results?  Link behaviours to incentive compensation models  Retrain staff  Monitor  Hold supervisors accountable  Establish disciplinary model  Educate the business Date of presentationInsert filename here 19
  20. 20. Contact details Simone Mitchell Partner DLA Piper T. 02 9286 8484 simone.mitchell@dlapiper.com 30 May 2014 20 This presentation is intended as a first point of reference and should not be relied on as a substitute for professional advice. Specialist legal advice should always be sought in relation to any particular circumstances and no liability will be accepted for any losses incurred by those relying solely on this presentation. Achieving Business Conduct Compliance through Auditing

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