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Media Partners:

Global TransparencyReporting Congress

5th Annual

Evolving Guidelines for Disclosing HCP Spend Across the Globe15-16 Apr i l 2015 • H i l ton London Paddington • London, UK

R E G I S T E R B Y 1 3 F E B R U A R Y 2 01 5 A N D S AV E £ 2 0 0 ! Join 200 of Your Colleagues

for a Timely, Regulatory and Industry Update

Best Practices for Implementing EFPIA Disclosure CodeJulie Bonhomme, Legal Affairs & Compliance Deputy Director, European Federation of Pharmaceutical Industries, EFPIA (Belgium)

Progress Report on Implementation of EFPIA’s Disclosure Code Nicolai Ellehuus, Head of Legal and Compliance, Nordics, Mundipharma (Denmark)

Peter Herrmann, Group Compliance Officer, Head Corporate Affairs and Compliance, Actelion Pharmaceuticals Ltd. (Switzerland)

Ekaterina S. Walløe, Competency Development Professional, Clinical Operations, Novo Nordisk A/S (Denmark)

Dr. Holger Diener, Managing Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry (Germany)

Andreas Gascard, Senior Director, EMEA & Canada Center of Excellence, HC Compliance & Privacy Global Operations, Johnson & Johnson (Germany)

Jonas Wellendorph, Team Leader HCP Office, Business Ethics Compliance, Novo Nordisk A/S (Denmark)

ABPI Featured AddressAileen Thompson, Communications Director and Project Lead for UK Disclosure Project, Association of the British Pharmaceutical Industry (ABPI) (United Kingdom)

The Physicians’ Perspective on Fostering Better Transparency in the Pharmaceutical Sector

Dr. Erzsébet Podmaniczky, Chair of the CPME Pharmaceuticals WG, Standing Committee of European Doctors (CPME) (Hungary)

Lessons Learned from U.S. Open Payments Reporting (Sunshine Law) Margaret Feltz, Executive Director, Corporate Compliance, Purdue Pharma (United States)

Maya A. Babu, M.D., MBA, Member Board of Trustees, American Medical Association, Neurosurgery Resident, Mayo Clinic (United States)

Comprehensive Agenda Inside Includes: Best Practices for Managing Consent to Disclose

Proactive Approaches for Determining Fair Market Value

Keys for Accurate Global Reporting— Data Remediation and Standardisation

How to Comply with Data Privacy Laws While Publishing HCP/HCO Payment and Transfers of Value

Challenges of Cross-Border Spend Reporting and Ways to Overcome Them

Why Onboarding and Qualification of Third-Parties Is Critical for Success

Presentations Representing:

Executive Sponsor:

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Conference Sponsors:

A Great Place to Meet Your Market!Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating

thought leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact Alexa Moore at +1 339-298-2107 or email alexa.moore@cbinet.com.

In its fifth year, CBI’s Global Transparency Reporting Congress provides critical information on emerging global guidelines and trends in reporting and managing

transparency in payments to healthcare professionals. Join 200 of your colleagues at a vital meeting devoted to dissecting the evolving country-specific requirements and

codes governing the management and reporting of physician spend.

ATTENDEE ACCLAIM:

“This educational meeting was a balanced and fair representation of the issues of financial interactions that pharma currently needs to grapple with. It offered a good practical understanding for how each global sector is moving forward with this and the sessions had excellent educational content.”

— Compliance Officer, Chugai Pharmaceutical Co. (United Kingdom)

“...as ever a comprehensive overview about the 'status quo' of transparency — presentations and discussion cover a broad spectrum of transparency regarding different aspects e.g., technical or strategic issues…”

— Director, Compliance Management, Daiichi Sankyo Europe GmbH (Germany)

“Comprehensive overview of transparency initiatives from Sunshine Act to EFPIA disclosure. Mark your calendar.”

— Medical Information Manager and Compliance Liaison, Sanofi-Aventis (Hungary)

WHO SHOULD ATTEND:

You will benefit from attending this event if you have responsibilities or involvement in the following areas:

• Compliance

• Transparency

• HCP Reporting

• Ethics

• Legal

• Finance

• IT

• Business Analytics

• Auditing

• Project Management

• Business Operations

• Commercial Operations

• Promotional Affairs

• Medical Affairs

Compliance / Legal / Ethics 39%

Commercial / Business Operations 15%

Transparency / Reporting 13%

Medical / Regulatory / Clinical Affairs 12%

Systems / IS / IT 9%

HCP Engagement / Relations 6%

Project / Program Management 6%

SEE WHO ATTENDED IN 2014:

Executive Sponsor:

DAY ONE WEDNESDAY, 15 APRIL 2015

7:45 Continental Breakfast and Conference Registration

8:45 Chairman’s Opening RemarksNicolai Ellehuus, Head of Legal and Compliance, Nordics, Mundipharma (Denmark)

Update on Requirements and Industry Implementation of EFPIA Disclosure Code

9:00 EFPIA OPENING ADDRESS Update on the EFPIA Disclosure CodeGain an update from EFPIA on the implementation of the EFPIA Disclosure Code on Transfers of Value from pharmaceutical companies to HCPs required in 2016. The first disclosures will be made in 2016 conveying information about payments made in 2015.

• Update on implementation of disclosure code

• Recommended best practices for implementing EFPIA’s code

• Role of EFPIA’s dedicated website — www.pharmadisclosure.eu

• Efforts to explain transparency objectives to healthcare professionals and healthcare organisations

Julie Bonhomme, Legal Affairs & Compliance Deputy Director,European Federation of Pharmaceutical Industries, EFPIA (Belgium)

9:45 Nordic Transparency — Practical Implementation of a Mix of Sunshine and EFPIA RulesA walkthrough of the practical implementation of transparency processes in a region representing both Sunshine law and EFPIA Code.

• Denmark:

* understanding the Danish Sunshine Law

* how to inform HCPs of reporting requirements

• Sweden, Norway, Finland:

* the creation of working groups

* what works in smaller organisations?

• Evaluating the implementation processNicolai Ellehuus, Head of Legal and Compliance, Nordics, Mundipharma (Denmark)

10:30 Networking and Refreshment Break

11:00 Around the World in 80 Days — A Tour of Various National Reporting MandatesLearn about the latest developments in existing regulations and emerging guidelines for transparency reporting around the world. Your tour guides explain how the United Kingdom, France, the Netherlands and other EU and Asian countries are approaching HCP spend reporting.• Advice on prominent aspects that govern how

industry reports on transactions of value• Discover the parallels and differences among

disclosure rules in EU and Asian countries • Gain guidance on the important components of

local requirements

• Review strategic and operational trends in relationship management in emerging markets

• Hear about the 'hot button issues' for HCP interactions in non-transparency reporting countries

• French Sunshine Act, German Data Protection, Latin America, Japan, Nordic Transparency — Denmark, Sweden, Norway, Australia, Asia, China, Russia, Croatia

Brian Sharkey, Director Compliance and Legal Affairs, Porzio Life Sciences, LLC (United States)

Christine Bradshaw, Director Regulatory and Compliance Services, Porzio Life Sciences, LLC (United States)

11:45 ABPI FEATURED ADDRESS Implementing the EFPIA Disclosure Code: the UK Perspective In the UK, the requirements of the EFPIA Disclosure Code have been incorporated in to the Association of the British Pharmaceutical Industry’s Code of Practice. The ABPI Code of Practice covers over 98% of the UK pharmaceutical industry and covers the promotion of medicines for prescribing to both health professionals and other relevant decision makers. It also includes requirements for interactions with health professionals and sets standards for the provision of information about prescription only medicines to the public and patients, including patient organisations. UK companies took the decision in 2013 to make their disclosures via a central platform, which the ABPI will host and manage.• Get a flavour of the key issues for UK companies in

implementing the EFPIA requirements• Gain insight into how the ABPI is working with the

medical community to raise awareness of the new requirements and to encourage HCP collaboration

• Learn more about how the UK’s searchable, centrally-hosted disclosure platform will work

Aileen Thompson, Communications Director and Project Lead for the UK Disclosure Project, Association of the British Pharmaceutical Industry (ABPI) (United Kingdom)

12:30 Networking Luncheon

Implementing the Strategy and Operations for Successful Transparency

13:45 Progress Report on Industry Implementation of EFPIA’s Disclosure Code At more than three months post the January 1, 2015 start of data collection by pharmaceutical companies in preparation for 2016 reporting, hear about the progress and pitfalls to date involved in establishing transparency reporting.• Focus on spend capture processes and systems• Updates on data privacy and disclosure concerns• Approaching transparency as a holistic process and

understanding how it affects your business• How central reporting differs from country-by-country• Do best practices exist? How should we benchmark?• Building in ways to manage data quality and validity• Issues with cross-border spend• Progress on managing communication with

HCOs and HCPsMarc Eigner, Partner, Polaris Management Partners (United States)

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14:30 Managing Risk in Working with Third-PartiesOnboarding and qualification of third-parties is critical to the success of transparency reporting. Consider methods to manage due diligence with third-parties and manage inherent risks.• A possible method for onboarding third-parties• Establishing a process for qualifying third-parties• Designing self-assessments for vendors• Understanding the difference in approach for

large and small companies• Identifying the best ways to organise and manage

sub-contracts• Determining whether third-parties are managed

globally, locally, by headquarters• While it may not be possible to audit all third-parties,

it may be necessary to identify third-parties with higher risk

Peter Herrmann, Group Compliance Officer, Head Corporate Affairs and Compliance, Actelion Pharmaceuticals Ltd. (Switzerland)

15:15 Networking and Refreshment Break

15:45 Managing Cross-border Activities and HCP Interactions• Legal issues resulting from cross-border activities• Managing, tracking and monitoring

cross-border activities• Anti-corruption compliance and

cross-border transactionsTim Robinson, Esq., Chief Knowledge Officer and General Counsel, MediSpend® (United States)

16:30 Interpreting Lessons Learned from U.S. Open Payments Reporting (Sunshine Law) into Actionable Strategies for Managing HCP Relationships and Consent AgreementsGain an update from the U.S. on lessons learned after the first full year of Open Payments reporting submitted 31 March 2015. The Center for Medicare and Medicaid Services (CMS) published 2013 physician payment data in September 2014. A detailed examination of physician and public response to the published data is provided. • What story does the published data tell?• Key takeaways from physician responses • Best practices for communicating with physicians• Is 'pre-reporting' effective?• Translating lessons learned into actionable practices

for managing consent Moderator:

John Patrick Oroho, Executive Vice President & Chief Strategy Officer, Porzio Life Sciences, LLC (United States)

Panelists:

Maya A. Babu, M.D., MBA, Member, Board of Trustees, American Medical Association; Neurosurgery Resident, Mayo Clinic (United States)

Margaret Feltz, Executive Director, Corporate Compliance, Purdue Pharma (United States)

Jodie Gillon, Head, External Interface Office, AstraZeneca (United States) (invited)

17:15 Concurrent Working Group Practicums

A Managing Consent and Relationships with HCPsManaging the communication and the relationship with healthcare professionals is critical to the success of a transparency program. • Types of documentation used to support

consent agreements• What type of response should be given when

consent is denied?• Hot-button issues for HCP interactions in

non-transparency reporting countries

B The Transparency JourneyThe structure of internal policies and processes greatly impacts the effectiveness and efficiency of your transparency initiative.• Internal processes for sharing ownership and

accountability for transparency program• Organising for accuracy and speed of recording

transfer-of-value at the point of transfer• Implement and monitor processes to ensure data

accuracy and verification

C Third-Party Due DiligenceSuccessful collaboration with third-parties requires an investment of time and an organised approach for communication, training and monitoring.• Potential pitfalls involved in working with third-parties

to collect data• Auditing and monitoring programs to ensure accuracy

• How are you sharing data standards with third-parties?

18:00 Close of Day One

Networking, Wine and Cheese Receptionimmediately following the final session on day one

DAY TWO THURSDAY, 16 APRIL 2015

8:00 Continental Breakfast

8:30 Chairman’s Review of Day OneNicolai Ellehuus, Head of Legal and Compliance, Nordics, Mundipharma (Denmark)

Critical Data Management and Privacy Issues

8:45 Unravelling the Complexities of Data Privacy in Countries Enforcing Disclosure of HCP Payment and Transfers of ValueHCP data may be recognized as personal data in a number of countries and thereby qualifies as protected. This complicates the approach for complying with data privacy laws while publishing HCP/HCO payment and transfers of value in an effort to achieve transparency. Gain a critical understanding of data privacy laws and its impact on complying with current or pending transparency codes and regulations, including:

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P A N E L

• Outline of EU data protection requirements dealing with using and disclosing personal data

• Discussion of the definition of personal data and whether HCP data from Europe qualifies

• Differentiation of transparency and data protection rules in UK and Germany

• Why Germany’s data protection laws are considered the most strict

• Comparing data transparency in the EU Medical Devices Regulation to trade secrets of the Devices’ manufacturer and document protection

• Understanding the U.S. safe harbor regime;• Overview of civil and criminal penalties related to

violations of data privacy regulations• Implications of the recent European Clinical

Trials Regulation Draft Directive with regard to data privacy

• How to create a framework for complying with data privacy laws

Pulina Whitaker, Partner, King & Spalding (United Kingdom)

Ulf Grundmann, Partner, King & Spalding (Germany)

9:30 Transparency Process in Germany — Pitfalls and OpportunitiesStriving for full disclosure is a challenging process — both legally and politically. However, there are very good reasons for this journey and a clear goal: to get rid of unfounded suspicion. • Where we are and what has been done to date• Stakeholder reaction• Specific issues in data privacy including the need for

physical signatures versus electronic signatures• Questions and problems to date and potential solutions• Looking forward — The process to support the

disclosure process Dr. Holger Diener, Managing Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry (Germany)

10:15 Networking and Refreshment Break

10:45 DATA: Disclosure, Accuracy, Transparency, Analytics — How DATA Should be Applied for Global NeedsData remediation and standardisation are key to accurate reporting — not simply technology or reporting software. Addressing EFPIA and other reporting needs — what you really need is clean data! If that data is inaccurate or incomplete, then the reports are wrong — no matter how you view it. There are strategies and tactics that you can employ in your business today that will yield highly accurate, low latent data sets that will lead to compliant transactions and reporting. End the Dirty Work: clean data doesn’t have to be a dirty job!

Greg Maynard, Director of Transparency & Aggregate Spend Solutions, Health Market Science (United States)

Methods for Success in Working with Healthcare Professionals

11:30 The Physicians’ Perspective on Fostering Better Transparency in the Pharmaceutical Sector Hear directly about the physicians' perspective regarding transparency in the pharmaceutical sector. • Understand how physicians envisage the relationships

with the healthcare industry• What are the preferred methods of communication

between HCPs and industry?• Find out what has been done so far by the

Standing Committee of European Doctors to foster better transparency

Dr. Erzsébet Podmaniczky, Chair of the CPME Pharmaceuticals WG, Standing Committee of European Doctors (CPME) (Hungary)

12:15 Networking Luncheon

13:30 Best Practices for Managing Consent to DiscloseExamine all the approaches for successfully managing relationships with healthcare professionals, particularly regarding consent to disclose.• How to get consent• What information do we need to update healthcare

professionals on transparency?• Best practices for developing communication strategies• What communication strategies have been

most effective?• Preparing consent documentation• Strategising response and initiatives if/when

physicians deny consent• Dispute resolution processEkaterina S. Walløe, Competency Development Professional, Clinical Operations, Novo Nordisk A/S (Denmark)

Jonas Wellendorph, Team Leader HCP Office, Business Ethics Compliance, Novo Nordisk A/S (Denmark)

14:15 Proactive Approach for Determining Fair Market Value Realise the critical importance of the method for determining Fair Market Value for Fee-for-Service (FFS) agreements with healthcare professionals. Empower the organisation with the ability to communicate a transparent methodology for how HCPs are paid. • Overview of Fair Market Value and why it matters in

regards to transparency• Triggering questions and things to consider• Confirm the company method is consistent, simple

and transparent• One possible option for how to calculate and

justify FMV• Establish a global FMV policy to remain consistent

with understanding of national and international reporting regulations

Andreas Gascard, Senior Director, EMEA & Canada Center of Excellence, HC Compliance & Privacy Global Operations, Johnson & Johnson (Germany)

15:00 Close of Conference

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Global Transparency Reporting Congress5th Annual

Evolving Guidelines for Disclosing HCP Spend Across the Globe15-16 Apr i l 2015 • H i l ton London Paddington • London, UK

R E G I S T E R B Y 1 3 F E B R U A R Y 2 01 5 A N D S AV E £ 2 0 0 !

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