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Global TransparencyReporting Congress

4th Annual

Comply with Country-Specific and Regional HCP Spend Codes8-9 Apr i l 2014 • H i l ton London Paddington • London, UK

CHAIRMAN Hamzah Baig, M.D., MRCP, MFPM, Portfolio Medical Director, GlaxoSmithKline

David Eves, Compliance Officer, Chugai Pharmaceutical Co.

Peter Herrmann, Ph.D., Group Compliance Officer, Actelion Pharmaceuticals

Andrew Powrie-Smith, Director, ABPI Scotland

Uwe Steinert, Associate Director, Enterprise Services, Information Technology, Bristol-Myers Squibb

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

CLE and CPE Credits Available!

Pending Approval

• Discover better ways for your company to embrace EFPIA code positions

• Better prepare for disclosure reporting requirements regardless of a local regional effort

• Differentiate between minor disputes and major infraction

• Evaluate what payments and information must be disclosed

• Steer clear of fair market value errors

• Implement an EFPIA disclosure solution within an international environment

As we face a new era of global transparency, it is more critical than ever to have efficient and scalable solutions in place to collect, track and report HCP spend. Join the industry-leading Congress and gain proven strategies to…

Perspectives Representing:

Supporting 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.

“Great networking opportunity leveraging on common challenges.”— Edoardo Lazzarini, European

Compliance Officer, BIOMET Europe

“Amazing first hand info on new global regulations and insight on how companies are preparing for it. Highly recommended…to prepare for implications and reporting requirements.” — Agnes Canonica, GM-Americas,

MD Events

WHO SHOULD ATTEND:You will benefit from attending this event if you are a senior-level professional from bio/pharmaceutical and medical device companies with responsibilities in any of the following areas:• Compliance• HCP Reporting• Legal• Finance• IT• Business Analytics• Auditing• Project Management• Business Operations• Business Process• Promotional/Affairs• Medical Affairs

This conference will also benefit consultants, technology vendors and companies providing services to the above audience.

“A great opportunity for all colleagues around the world to share better practices and help to increase efforts for transparency.”

— Meltem Ozker Gunduz, Legal Affairs Director, Novo Nordisk

• Suzanne Leech, Stakeholder Strategy Manager, Pfizer Inc

• Dominika Spilarova, HCP Processes Manager, Covidien

• Andrea Sala Cantarell, Process Performance Management Director, Covidien

• Attila Horváth, Medical Information Manager and Compliance Liaison, Sanofi-Aventis

Additional Industry Perspectives Include:

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DAY ONE TUESDAY, 8 APRIL 2014

7:30 Continental Breakfast & Conference Registration

8:15 Chairman’s Opening RemarksHamzah Baig, M.D., MRCP, MFPM, Portfolio Medical Director, GlaxoSmithKline (United Kingdom)

Local and Regional Disclosure Adoption

8:30 OPENING ADDRESS EFPIA Disclosure Code — The Current Environment and Future DirectionAs of 31 December 2013, members of EFPIA are required to adopt the new Code on Disclosure of Transfers of Value From Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations. Receive an overview of the published code’s mandates and the status of local adoption. Learn how to best approach EFPIA code adoption from your company’s perspective and find out what transparency might look like by 2020.• Discover the components of EFPIA’s disclosure code• Learn what countries are doing to adopt the code• Identify better ways for your company to embrace the

code’s provisions Anne Erwin, Managing Director, ICE – Innovative Compliance & Ethics LTD

9:15 A Tour of Various National Reporting MandatesYour guides explain how the United Kingdom, France, the Netherlands and other EU and Asian nations are approaching HCP spend reporting. Whether you’re bound by disclosure requirements from multiple nations or just curious about what’s going on across your border, this journey offers easy-to-follow advice on the prominent aspects that govern how industry reports on transactions of value.• Find out the parallels and differences among

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

of local requirementsD. Jeffrey Campbell, J.D., President & CEO, Porzio Life Sciences, LLC (United States)

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

10:00 Networking and Refreshment Break

10:30 European Trends in Transparency and Disclosure Requirements and Its Operational Impacts on Life Sciences CompaniesThe European Life Sciences industry is currently facing a reinforcement of the transparency regulatory requirements with the adoption of the EFPIA code of disclosure in June 2013. The transposition of the EFPIA code within 33 member associations in Europe will necessarily impact daily operations in many companies. Without implementing proper reporting practices, processes and tools, increased transparency can pose needless but liabilities and administrative burdens. In light of these recent developments, what measures are European companies taking to comply with increasingly complex regulatory environment? More

importantly, what does the future hold concerning developments in aggregate spend, transparency and disclosure?Diva Duong, Vice President Compliance EMEA/APAC,Cegedim Relationship Management (Paris, France)

11:15 Local Versus Regional Approaches to Transaction ReportingDepending on what nation your company does business in, your pharmaceutical or biotech organisation may face HCP reporting mandates from a local point of view, a broader regional plan or both. Walk away with a greater understanding of these approaches by learning the benefits and drawbacks to each — All explained in a way that helps your company better prepare for disclosure reporting requirements regardless of a local or regional effort.• Increase your knowledge about regional

versus local disclosure approaches• Discover what aspects of local disclosure

benefit pharmaceutical companies• Gain insight into how your company’s efforts

fit into local and regional effortsMichael Bartke, Director, Compliance Management, Daiichi Sankyo Europe GmbH (Germany)

12:00 Networking Luncheon

13:15 Transparency Disclosure RoundtableDuring this interactive knowledge exchange, meet your fellow delegates, tackle questions posed by the moderator and discuss aspects of Transparency that are important to you in small break-out groups. Share and gain insights on topics that include the following:• What do you think the public’s expectations

are with HCP transaction reporting?• Are tax implications being considered as part of

your Transparency disclosure strategy?• How are you accounting for data privacy?• What is your strategy for tracking cross border spend?• Are you considering outsourcing as part of

your overall strategy?Facilitators: Mike McNeal, Director, PricewaterhouseCoopers (United States) Sarah Otten, Senior Director, Corporate Compliance, Vertex Pharmaceuticals David Wysocky, Principal, PricewaterhouseCoopers

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

Understand Your Role in Disclosure Compliance

14:00 ABPI FEATURED ADDRESS Dissect the Relationship Between Manufacturers and HCPsThe ABPI’s guidance will likely have recommendations for all stakeholders to become familiar with adopting the EFPIA disclosure code. Key to embracing these provisions is the idea that pharmaceutical organisations, HCPs and medical device companies all play a part in spend reporting. One of our most popular speakers returns to explain how your company must work with HCPs to explain — and then influence — compliance. Also, take an in-depth look into a key question about disclosure that ABPI wrestles with — What types of information and payments must be disclosed?

• Determine the role of HCPs in spend reporting• Look into what types of payments are subject

to disclosure• Learn some of the key elements within ABPI’s

disclosure guidanceAndrew Powrie-Smith, Director, ABPI (Scotland)

14:45 Networking and Refreshment

Break Hosted by:

15:15 Who Owns the Disclosure Process?Who in an organisation should be in charge of the HCP spend disclosure process? Depending on whom you ask, answers range from compliance officers to finance directors, to general counsel and even IT directors. Learn what companies are doing when it comes to organising transparency leadership teams and establishing ownership, roles and responsibilities. Find out what steps have been successful in encouraging collaboration to achieve disclosure compliance. • Understand how companies view global

transparency governance • Learn techniques that can increase cooperation

among departments and geographical regions• Hear how companies have organised to outline their

strategy and execute their tactics towards achieving consistency in transparency disclosure across their organisations

Moderator: Sarah Volden, Manager, PricewaterhouseCoopers (United States)Panelists: Peter Herrmann, Ph.D., Group Compliance Officer, Actelion Pharmaceuticals (Switzerland)

Ekaterina S. Walløe, Competency Development Professional, Clinical Operations, Novo Nordisk A/S (Denmark) Suzanne Leech, Stakeholder Strategy Manager, Pfizer (United Kingdom)

Montserrat Alvarez, Global Program Leader Xpend Transparency, Novartis Pharma AG (Switzerland)

Optimise Data Disclosure Systems

16:00 Determine the True Financial Value of a TransactionAt the core of spend disclosure is the need to attach a fair market value to various transactions and services provided by an HCP. There are some potential Transfers of Value that may be easy agree on the “real value” transferred, but other areas are much more vague (e.g., an HCP serving on a journal’s advisory board). Look at the models available to determine the value of transactions, and find out how to avoid obstacles that can encumber the process.• Discuss examples of how to determine a

transaction’s financial worth• Recognize different types of transactions

and how to account for them• Learn ways to steer clear of fair market value errorsJosé Ramos, Transformation Manager, Lilly S.A. (Spain)

16:45 Global Transparency — Focus on HCP/O Engagement ProcessAs companies struggle with global transparency, many focus entirely on aggregation processes and systems. However, the challenge begins long before an HCP spend is aggregated or a report is created. This is especially true in regions where HCP spend capture processes and systems are not mature. In this session, the criticality, to transparency, of the entire HCP engagement process is discusses.• HCP/O Engagement Process Best Practices

Overview (FMV, Background Checks, Contracting, etc.)

• HCP/O Engagement System Best Practices Overview• Solving Global Transparency by

First Focusing on HCP EngagementsDavid Eiben, Director, Business IS Commercial Operations, Boehringer IngelheimMarc Eigner, Partner and Co-Founder, Polaris Solutions

17:30 Close of Day One

Networking, Wine and Cheese Reception

immediately following the final session on day one

DAY TWO WEDNESDAY, 9 APRIL 2014 8:00 Continental Breakfast

8:30 Chairman’s Review of Day OneHamzah Baig, M.D., MRCP, MFPM, Portfolio Medical Director, GlaxoSmithKline (United Kingdom)

8:45 Proactive Disclosure System Implementation — Building Effective Communication ProcessesThe success or failure of your HCP spend disclosureis rooted in your organisation’s ability to collect andreport accurate data. Bridge your teams’ knowledgegap about disclosure by pinpointing what concernsthe team needs to know about before updatingreporting systems to comply with any local or regionaldisclosure codes.• Hear the Covidien approach to gaining buy-in

from various departments including sales, IT, compliance and legal

• Understand how to capture your current systems to ensure you are capturing spend automatically• Discuss how to best convey what the final reporting product should look likeDominika Spilarova, HCP Processes Manager,Covidien (Czech Republic)Andrea Sala Cantarell, Process PerformanceManagement Director, Covidien (Switzerland)

9:25 Take Control of the Details Behind Your DataAs reporting mandates put pressure on pharmaceutical organisations to collect HCP spend information, take a step back to determine exactly what types of HCPs are affected (e.g., physicians, nurses, medical students) and what array of data you want to collect about these professionals. Consider the level of disclosure needed

P A N E L

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CASE STUDY

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in light of your local or regional codes and deliberate corporate budget considerations prior to collecting the data. Finally, discuss whether your organisation’s customer relationship management (CRM) system can be an ally in producing disclosure reports, and how to navigate through situations in which multiple CRM systems are present.• Determine the different types of HCPs you

need to report on• Consider what data points to collect on

HCPs and your interactions with them• Receive tips about a CRM system’s capabilities with

regard to disclosure reportsGreg Maynard, Director, Compliance Solutions for Life Sciences, Health Market Science (United States)Darryl Williams, Director MDM & API Platform Solutions, Health Market Science (United States)

10:05 Networking and Refreshment Break

10:35 Chugai Pharma UK’s Approach to Aggregate Spend, Disclosure and Transparency on a BudgetHear directly from a Compliance Officer at a small- to medium-sized pharmaceutical company who has successfully managed aggregate spend in the first two years of disclosure on a small budget.• Examine system relationships and how aggregate

spend can be tracked manually through information captured from a finance system

• Learn how to implement a low-tech system to demonstrate where and on whom money was spent

David Eves, Compliance Officer, Chugai Pharmaceutical Co. (United Kingdom)

11:15 The EFPIA Disclosure and National Requirements — How to Implement a Global 2 Local (G2L) International IT SystemBy 2016, European pharmaceutical companies will have to publicly disclose the monetary value of any financial sponsorship and other significant indirect support provided to patient, healthcare professionals and organisations. With these critical issues in mind, this panel will be discussing these significant legal developments and providing some examples of such requirements in some European countries. In addition, this panel debates the important points on how to implement an EFPIA disclosure solution within an international environment.• Discuss view points on how to develop and

implement a single global/local EFPIA transparency solution.

• Understand from real examples how to manage international/ cross-borders events

• Gain an understanding on the corporate IT integration and critical issues to address in order to develop and implement a global/local solution

Moderator: Laurent Clerc, Regulatory Affairs Expert, BMI SYSTEM (United Kingdom)

Panelists: Uwe Steinert, Associate Director, Enterprise Services, Information Technology, Bristol-Myers Squibb (Germany)

11:55 Networking Luncheon

HCP Dispute Resolution and Data Privacy

13:10 Effective Means of Supervising Data Disputes and Monitoring PrivacyIt’s inevitable that, at some point, an HCP will

challenge your organisation’s disclosure data. Learn

proven routes to take that can help you effectively

— and professionally — review these disputes with

HCPs. Understand the legal responsibilities you may

have in complying with voluntary reporting standards

and how those obligations translate into the dispute

resolution process. Also, learn to differentiate between

minor disputes and major infractions.

• Find out methods to resolve HCP disputes

• Explore legal aspects associated with

HCP challenges

• Note the balance between voluntary reporting

and disputes

• Implications of data privacy laws

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

13:50 Transparency Initiatives in Europe — Where Do Physicians Stand?While cooperation between the medical profession

and the pharmaceutical industry is important and

necessary at all stages of the development and

use of medicines, it is crucial that it is done in full

compliance with ethical standards. Several initiatives

have been taken to foster better transparency in the

pharmaceutical sector, both at European and national

levels. What does this mean for European physicians?

How do they envision implementing the new rules?

• Learn more about what physicians

think about these new initiatives

• Find out what has been done so far by medical

associations in Europe to foster better transparency

Moderator: TBA

Panelists: Katrín Fjeldsted, M.D., President, Standing Committee of European Doctors (CPME) (Belgium)

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

Michael Bartke, Director, Compliance Management, Daiichi Sankyo Europe GmbH (Germany)

14:30 Close of Conference

P A N E L

P A N E L

CASE STUDY

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4th Annual Global Transparency Reporting Congress PC14105

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SUBSTITUTION AND CANCELLATION: Your registration may be transferred to a member of your organisation up to 24 hours in advance of the conference. Cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a £245 administrative charge. No refunds will be made after this date; however, the registration fee less the £245 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the conference registration fee only. CBI reserves the right to alter this program without prior notice. Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made without notice. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or CBI.

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R E G I S T E R BY 7 F E B R U A R Y 2 0 1 4 A N D S AV E £ 2 0 0 !

Global TransparencyReporting Congress

4th Annual

Comply with Country-Specific and Regional HCP Spend Codes8-9 Apr i l 2014 • H i l ton London Paddington • London, UK

Global TransparencyReporting Congress

4th Annual

Comply with Country-Specific and Regional HCP Spend Codes8-9 Apr i l 2014 • H i l ton London Paddington • London, UK

ANY QUESTIONS OR TO REGISTERCALL Juliet Nelson 339-298-2140

OR FAX TO MY ATTENTION 781-939-2696email: juliet.nelson@cbinet.com