DRAFT AGENDA

1

19-21 May 2015

Athens Hilton Athens, Greece

2015 Global MedTech Compliance Conference, Athens 19-21 May

DAY TIME PROGRAM

TUESDAY 19 May

08.00 – 17.00 Global Medical Technology Alliance (GMTA) (Parallel session) - Members only (Thalia 1)

10.00 – 17.00 Greek Distributor Training (SEIV) – Open session requiring separate registration (in Greek) (Parallel session) (Thalia 2&3)

10.00 – 12.30 AdvaMed Device and Diagnostics Compliance Group (DDCG) (Parallel session) - Members only (Hesperides)

10.00 – 12.30 MedTech Europe Compliance Network (CN) (Parallel session)- Members only (Santorini)

12.30– 13.45 Joint DDCG-CN-GMTA-SEIV Lunch (Terpsichore D)

13.45 – 17.00 Joint DDCG-CN Session - Members only (Santorini)

18.00 – 19.30 PwC Compliance Achievement Award & Networking Cocktail (Galaxy Room)

DAY TIME PROGRAM

WEDNESDAY 20 MAY

07.30 Registration and welcome coffee (Terpischore Pre Function Room)

09.00 – 09.30 Opening session (Terpsichore AB) ‐ Associations CEOs Panel i.e. Steve Ubl - AdvaMed, Serge

Bernasconi - MedTech Europe & Paul Arnaoutis – SEIV (confirmed)

09.30 – 9.50 Welcome address

09.50 – 10.45 Plenary session: Anti-corruption, business ethics, innovation & partnerships: A governmental perspective ( Terpsichore AB)

‐ Candice Welsch, Chief, Implementation Support Section Corruption and Economic Crime Branch United Nations Office on Drugs and Crime (confirmed)

Moderator: tbc Panel Description: Discussion with international organisations and governmental officials on the value of public-private partnerships to fight corruption, including views on anti-corruption best practices

DRAFT AGENDA

2

19-21 May 2015

Athens Hilton Athens, Greece

and current trends.

10.45 – 11.15 Networking break (Convention Level and the Erato Terrace)

11.15 – 12.30 Parallel session 1: Expert panel on distributor-related issues: “How Would Experts Manage this Distributor Compliance Scenario (Thalia 123)

‐ Bronwen Taylor, VP, Compliance & Risk Management, Stryker Corporation

‐ Moderator: tbc Panel Description: Senior compliance officers will be invited to discuss and comment on a hypothetical roll-out scenario relating to the topic of distributors.

11.15 – 12.30 Parallel session 2: Did Sunshine bring transparency? (Hesperides)

‐ Laure Le Calvé, Avocat associée, LCH (confirmed) ‐ EFPIA (confirmed) ‐ Ann S. Brandt, Partner, HealthCare Appraisers, Inc.

(confirmed)

Moderator: Frederick Robinson, Partner, Norton Rose Fulbright (confirmed) Panel Description: Discussion on the latest transparency developments, and how these initiatives can meet the pre-determined objectives, and more generally provide value.

11.15 – 12.30 Parallel session 3: Where is the compliance officer profession headed? (Santorini)

‐ Arthur Muratyan, Secretary General, ETHICS (confirmed) ‐ Kathleen M. Boozang, Associate Dean for Academic

Advancement & Professor of Law, Seton Hall University School of Law (confirmed)

Moderator: UL (confirmed) Description: Discussion on the role and the profession of the Healthcare Compliance Officer. This includes considerations such as the current and future trends of this professions, its place within the company, as well as the existing training programs and educational pathways for Ethics and Compliance practitioners.

DRAFT AGENDA

3

19-21 May 2015

Athens Hilton Athens, Greece

11.15 – 12.30 Parallel session 4: Industry consolidation: What does it mean for compliance? (Thalia 4) Moderator: tbc Description: As the MedTech industry is consolidating at an unprecedented speed, this session will discuss, what does it mean practically for the compliance function and what are the pitfalls in deal-making that should be avoid (e.g. before-during-after, re-consolidation, rebates, competition law).

12.30 – 13.45 Networking Lunch (Terpsichore D)

13.45 – 15.15 "Coffee Talk": Get Your National Update, and Discuss the Latest Developments with Your Peers (requires participant selection at the time of registration, limited to 10 per table) (Thalia 1 2 and 3) Moderator: Mike Koon, Partner, Norton Rose Fulbright (confirmed)

‐ Brazil: ‐ Colombia:

‐ China: ‐ Denmark: ‐ Greece: ‐ Middle East region: ‐ India: ‐ Russia: David Smith, Executive Director, Fraud Investigation

& Dispute Services, EY (Russia) (confirmed) ‐ Poland & Eastern Europe: ‐ France: Laure Le Calvé, Avocat associée, LCH (confirmed) ‐ Spain & Southern Europe

‐ USA ‐ Australia/Japan ‐ Europe: ‐ International Fair-Market Value: Ann S. Brandt, Partner,

HealthCare Appraisers, Inc. (confirmed)

15.15 – 15.45 Networking break (Convention Level and the Erato Terrace)

15.45 – 16.00 “Public Perception and Media”? Views on MedTech business ethics (Terpsichore AB)

DRAFT AGENDA

4

19-21 May 2015

Athens Hilton Athens, Greece

16.00 – 17.00 Plenary session: CEO Roundtable on Global Compliance (Terpsichore AB)

‐ Stefan Wolf, EDMA Board member & CEO for the HHS Business Unit, Siemens Healthcare Diagnostics (confirmed)

‐ Jeff Dunn, President and CEO, SI-Bone (confirmed) ‐ Mike Mussallem, Chairman & CEO, Edwards Lifesciences

Corporation (confirmed)

Moderator: Ted Acosta, Partner, Ernst & Young (invited) Description: In this session, business leaders will provide their thoughts on what the industry is going through right now in the field of ethics and compliance (e.g. transparency, consolidation, phasing out of direct sponsorship). This session also provide the "tone at the top", illustrating the support of business leaders to the legal and compliance community, commenting on the role of trade associations in this field of ethics and compliance as well as providing the opportunity to explain what they would like to see in terms of compliance in their company.

18.30 – 20.00 Cocktail Reception (TBD)

THURSDAY 21 May

07.00 Registration (Terpischore Pre Function Room)

08.45 – 10.00 Plenary session: Direct sponsorship of HCPs to third-party organized conferences: Global trends and challenges (Terpsichore AB) Moderator: PwC (confirmed) Description: Direct sponsorship, i.e. the provision of financial support to healthcare professionals (“HCPs”) by healthcare companies to attend passively third-party medical education conferences has been a topic of significant importance. Direct sponsorship is not allowed in certain countries and it is a big topic in all the other countries, some of them taking different measures to limit or prohibit various forms of sponsorship. In light of this fast-changing environment, the discussion will examine the subject in detail and to try to identify the challenges ahead, when direct sponsorship will not be possible anymore.

DRAFT AGENDA

5

19-21 May 2015

Athens Hilton Athens, Greece

10.00-11.00 Plenary session: Exchange of best practices: Meeting the challenges of the transition towards an “indirect-only-sponsorship” model (Terpsichore AB)

‐ Danie du Plessis, Senior Vice President, Medical International, GSK (confirmed)

‐ Linda Sneddon, Compliance MPD EMEA, WL Gore & Associates (confirmed)

‐ Anthony McQuillan, EMEAC Legal & Compliance, Vice

President, Medtronic (confirmed)

Moderator: tbc Description: With industry planning to move out of direct sponsorship across the world and more particularly in Europe, China and Brazil, there are many challenges that need to be addressed in order to ensure a smooth transition. Such challenges include e.g. how to continue to support medical education, how to communicate to customers, how to set up good processes for managing the compliance risks existing with indirect sponsorship, etc. and will be discussed in this session.

11.00 -11.30 Networking break (Convention Level and the Erato Terrace)

11.30 -12.35 Parallel session 1: Local implementation of the EDMA/Eucomed “Direct Sponsorship Phase-out” recommendation: Challenges for national associations in Europe (Thalia 1,2,3)

‐ Anna Lefevre Skjöldebrand, CEO, Swedish Medtech &

Chairwoman of the Eucomed National Associations

Network (confirmed) ‐ Gerry Livadas, General Secretary, SEIV (confirmed) ‐ Lorenzo Fracassi, Consigliere Delegato, Dasit Group

S.p.A. & Member of the EDMA Board (confirmed)

Moderator: Description: The EDMA ExeCo and Eucomed Board recommendation to phase out direct sponsorship by the end of 2017 has important implications for, and raises many concerns from, the national associations, whose membership is much broader than the EDMA/Eucomed membership, including many SMEs. Moreover, the economic circumstances in some of the countries create a situation where HCPs need the financial support from industry in order to receive the necessary continuing medical education. Such challenges

DRAFT AGENDA

6

19-21 May 2015

Athens Hilton Athens, Greece

and how to overcome them will be discussed in this session.

11.30 -12.35 Parallel session 2: Indirect Sponsorship and new approaches to third-parties: What are the options and what’s ahead? (Hesperides Room) Moderator: Robert McCully, Partner, Shook, Hardy and Bacon (confirmed) Description: This session will discuss how to organize the financial support to third-parties and how to manage grants in order to avoid new corruption risks and existing pitfalls.

11.30 -12.35 Parallel session 3: How to organize the communication to customers? Communicating new support structures to HCPs (Santorini)

‐ Rick Peterson, General Counsel, AAOS (confirmed) Moderator: tbc Description: The panel will be discussing the challenges and exchange best practices how to communicate effectively, the changes brought in compliance objectives.

11.30 -12.35 Parallel session 4: Best practices in distributors due diligence (Thalia 4) Moderators: Red Flag (invited) Description:

12.35 -13.35 Networking Lunch (Terpsichore D)

13.35 – 14.50 Plenary session: Moving to new models of support for medical education: Considerations from physicians and scientific societies (Terpsichore AB)

‐ Karen Hackett, CEO, AAOS (confirmed)

‐ Isabel Bardinet, CEO, ESC (confirmed) Moderator: Skye Potesta, Medical Director, Advanced Surgical Device Division, Smith & Nephew (invited) Description: Discussion with scientific societies on how the changing compliance landscape affects continuing medical education of healthcare professionals (HCPs) and how to ensure that HCPs around

DRAFT AGENDA

7

19-21 May 2015

Athens Hilton Athens, Greece

the world continue to have access to the education they need.

14.50 – 15.00 Closing remarks (Terpsichore AB) Sinéad Keogh, Director, Irish Medical Devices Assosication (IMDA) (confirmed)

15.00 Adjournment