THE PULSE: LIFE SCIENCES WEBINAR HOW COMPLIANT IS YOUR BUSINESS? A PROACTIVE APPROACH TO REGULATORY COMPLIANCE
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1 THE PULSE: LIFE SCIENCES WEBINAR HOW COMPLIANT IS YOUR BUSINESS? A PROACTIVE APPROACH TO REGULATORY COMPLIANCE Dr. Simone Mitchell & Sammy Fang Tuesday 4 August 2015
2 Introductions and outline 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. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
3 1. THE NEED FOR COMPLIANCE AUDITS
4 1. The need for compliance audits What are the benefits? Identify potential risk exposures. Anticipate and prevent issues before they arise. Should result in increased awareness by employees, business partners and contractors of the obligations and requirements imposed by law, policies and procedures. Provide insight to allocating limited resources. Demonstrate a culture of compliance, including to regulators. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
5 1. The need for compliance audits Areas of focus: Anti-bribery and anti-corruption Transparency Anti-trust The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
6 1. The need for compliance audits Areas of concern: Interactions with HCPs. Interactions with government agencies and officials. Interactions with consumers. Interactions with advocacy groups. Charitable contributions. Interactions with wholesalers. Relationships with distributors. Involvement in industry bodies/medical associations. Joint ventures and other third party transactions. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
7 2. PREPARING THE BUSINESS FOR AN AUDIT
8 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. Existing policies and procedures. Training. Volume of transactions/annual turnover. Level of processes and controls. Responsibility. Current risk areas from local market enforcement action. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
9 2. Preparing the business for an audit Planning and developing audit protocol 1. Obtain buy-in for the audit scope and methodology. 2. Developing audit protocol: background materials and audit overview audit teams and resources lead contacts for the audit data privacy and local law restrictions use of erooms for handling of data. 3. Conduct kick off meetings will all in-market business, legal and compliance leads and related parties. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
10 2. Preparing the business for an audit Planning and kick-off 1. Schedule status updates to all stakeholders. 2. Prepare questionnaire and data request. 3. Prepare communication explaining the audit to the business: mindful of local market considerations; and use of appropriate language for the local business. 4. Conduct pre-market calls with the business to better prepare for the audit. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
11 3. CONDUCTING THE AUDIT
12 3. Conducting an audit Paper/ Accounting Audit Interviews Reporting Implementation The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
13 3. Conducting an audit Paper audit Locate policies and other control documents. Identify other documents/ sources of information. Sampling can be random or targeted. Finalise audit work plan during this phase. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
14 3. Conducting an audit Forensic accounting audit Forensic accounting review by accounting firm. Walkthrough meetings with the local finance team. Select test samples. Conduct forensics review of selected transactions. Handover of audit results to legal team prior to interviews. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
15 3. Conducting an audit Interviews/ Transaction testing Determine who you will interview: business team third party vendors/distributors. Order of interviews can be important. Develop interview guidelines. Plan questions but be prepared to be flexible. Allocate enough time. Mindful of local cultural and regulatory considerations. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
16 4. WHAT TO DO WITH THE RESULTS?
17 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 Tone from the top to the bottom How are policies implemented Speaker training occurs regularly but internal training is mainly for new employees only Dept. involved Various (e.g. HR, Compliance, Marketing, etc) The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
18 4. What to do with the results? Identify issue Assess & triage issue Implement follow up/corrective action Evaluate corrective action & related results The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
19 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. Set out targeted timeline for completion. Schedule review of corrective action. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
20 4. What to do with the results? Link behaviours to incentive compensation models. Retrain staff. Monitor. Hold supervisors accountable: financial/ budgetary incentives heightened reporting obligations. Establish disciplinary model. Educate the business. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
21 Contact details Dr. Simone Mitchell Partner DLA Piper T simone.mitchell@dlapiper.com Sammy Fang Partner DLA Piper T sammy.fang@dlapiper.com 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. The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August
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