in PDF - Global MedTech Compliance Conference

19-21 May 2015
Athens Hilton
Athens, Greece
DRAFT AGENDA
2015 Global MedTech Compliance Conference, Athens
19-21 May
DAY
TUESDAY
19 May
TIME
08.00 – 17.00
10.00 – 17.00
10.00 – 12.30
10.00 – 12.30
12.30– 13.45
13.45 – 17.00
18.00 – 19.30
DAY
TIME
WEDNESDAY 07.30
20 MAY
PROGRAM
Global Medical Technology Alliance (GMTA)
(Parallel session) - Members only
(Thalia 1)
Greek Distributor Training (SEIV) – Open session requiring separate
registration (in Greek) (Parallel session)
(Santorini)
AdvaMed Device and Diagnostics Compliance Group (DDCG)
(Parallel session) - Members only
(Terpischore AB)
MedTech Europe Compliance Network (CN)
(Parallel session)- Members only
(Hesperides
Joint DDCG-CN-GMTA-SEIV Lunch
(Terpsichore Pre-Function area)
Joint DDCG-CN Session - Members only
(Terpischore AB)
PwC Compliance Achievement Award & Networking Cocktail
(Galaxy Room)
PROGRAM
Registration and welcome coffee
(Terpischore Pre Function Room)
09.00 – 09.30
Welcome Address by Paul Arnaoutis, CEO, SEIV
09.30 – 10.45
Plenary session: Anti-corruption, business ethics, innovation &
partnerships: A governmental perspective ( Terpsichore AB)
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Candice Welsch, Chief, Implementation Support Section
Corruption
and
Economic
Crime
Branch
United Nations Office on Drugs and Crime (confirmed)
Mary Crane-Charef, Policy Analyst, Directorate for
Financial and Enterprise Affairs, Corporate Affairs
Division, OECD (confirmed)
Peter van Veen the Director of TI-UK’s Business Integrity
Programme (confirmed)
Bram van Houten, Policy Officer at Ministry of Health,
Welfare and Sport (confirmed)
Moderator: Kathleen Hamann, Partner, White and Case
Panel Description: Discussion with international organisations and
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governmental officials on the value of public-private partnerships to
fight corruption, including views on anti-corruption best practices
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 2,3)
‐ Bronwen Taylor, VP, Compliance & Risk Management,
Stryker Corporation (confirmed)
‐ Meni Styliadou, Head of Compliance - Europe Middle East
and Africa, Alcon (confirmed)
‐ Cathy Kanzler, Compliance Officer, Corporate, Olympus
Corporation of the Americas (confirmed)
‐ Matt Wetzel, Senior Counsel, Global Compliance & Ethics,
Boston Scientific (confirmed)
Moderator: Geert van Gansewinkel, Partner & Managing Director
Europe, Polaris (confirmed)
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)
Andrew Powrie-Smith, Communications Director, EFPIA
(confirmed)
Ann S. Brandt, Partner, HealthCare Appraisers, Inc.
(confirmed)
Austin Byrd, Vice President, Chief Compliance Officer at
Spectranetics (confirmed)
Moderator:
(confirmed)
Frederick Robinson, Partner, Norton Rose Fulbright
Panel Description:
Discussion on the latest transparency
developments, and how these initiatives can meet the predetermined 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
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‐
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Advancement & Professor of Law, Seton Hall University
School of Law (confirmed)
Roeland Van Aelst, VP Health Care Compliance EMEA &
Canada, Johnson & Johnson (confirmed)
Nicole Schumacher, Attorney at Law, F. Hoffmann-La Roche
Ltd (confirmed)
Susan Hanstad, Senior Director of Corporate Compliance,
Endologix, Inc. (confirmed)
Moderator: Kavita Mehrotra, Global Head , Strategic Relationships,
Life and Health, UL EduNeering (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.
11.15 – 12.30
Parallel session 4: Industry consolidation: What does it mean for
compliance? (Thalia 1)
Speaker:
‐ Thomas Schumacher, Vice President, Ethics & Compliance,
Medtronic (confirmed)
‐ Heidi Jauch, Vice President Compliance Officer, Zimmer
(confirmed)
‐ Suzanne Durdevic, Senior Director, General Counsel
Europe, Boston Scientific (confirmed)
‐ Wes Porter, SVP, Chief Compliance Officer, Wright Medical
Technology, Inc. (confirmed)
Moderator: Christian Dargham, Partner, Avocat au Barreau de Paris,
Norton Rose Fulbright LLP (confirmed)
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, reconsolidation, 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) (Hesperides)
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Moderator: Mike Koon, Partner, Norton Rose Fulbright (confirmed)
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Brazil: Denis Jacob, Compliance Officer - Americas & Europe,
BD (confirmed)
China: Yuet Ming Tham, Partner, Sidley Austin (confirmed)
Germany : Adem Koyuncu, Partner - Lawyer and Medical
Doctor, Head of Life Sciences Germany, Covington & Burling
LLP (confirmed) – Joachim Schmitt, BvMed (confirmed)
Greece: Antony Poulopoulos, Partner, Attorney at Law, REED
SMITH (confirmed)
Middle East region: Ghadeer Alyacoub, Regional Health
Care Compliance Officer, MD&D Turkey, Middle East, Africa,
Johnson & Johnson (confirmed)
India: Ralph F. Ives, Executive Vice President, Global Strategy
and Analysis, AdvaMed (confirmed)
Russia: David Smith, Executive Director, Fraud Investigation
& Dispute Services, EY (Russia) (confirmed)
Poland & Eastern Europe: Mariusz Witalis, Partner, Ernst &
Young Business Advisory (confirmed)
France: Laure Le Calvé, Avocat associée, LCH (confirmed)
Italy & Southern Europe: Edoardo Lazzarini, EMEA
Compliance Officer, Biomet (confirmed)
USA: Scott Lane, Executive Chairman, Red Flag Group
(confirmed)
Australia/Japan
Europe: Diva Duong, Vice President Compliance EMEAAPAC, IMS Health (confirmed)
International Fair-Market Value: Ann S. Brandt, Partner,
HealthCare Appraisers, Inc. (confirmed)
Global Transparency: Alexis Wong, Manager, PwC
Pharmaceutical & Life Science Practice, PwC (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)
Speaker: Peter O'Donnell, Associate Editor, POLITICO (confirmed)
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)
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Moderator: Kathleen Meriwether, Americas Leader - Life Sciences,
Fraud Investigation & Dispute Services, Ernst & Young (confirmed)
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.
THURSDAY
21 May
18.30 – 20.00
Cocktail Reception (Fuga Restaurant)
Sponsored by
07.00
Registration
(Terpischore Pre Function Room)
08.45 – 10.00
Plenary session: Direct and indirect sponsorship of HCPs to thirdparty organized conferences: Global trends and challenges
(Terpsichore AB)
Speakers:
 Carlos Gouvea, President, Aliança Brasileira da Indústria
Inovadora em Saúde (ABIIS) (confirmed)
 Angela Main, VP Compliance, Zimmer Asia-Pacific
(confirmed)
 Stephanie Chew, Compliance Program Director, Medtronic
(China) (confirmed)
 Tanya Vogt, Executive Officer, SAMED (confirmed)
Moderator: Jean McKiernan, Director, Pharmaceutical & Life
Sciences, PricewaterhouseCoopers LLP (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 fastchanging 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.
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10.00-11.00
Plenary session: Exchange of best practices: Meeting the challenges
of the transition towards an “indirect-only-sponsorship” model
(Terpsichore AB)
‐
‐
‐
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Hugo Gomes Da Silva, Vice president & Head Global Medical
affairs rare disease and gene therapy, GSK (confirmed)
Linda Sneddon, Compliance MPD EMEA, WL Gore &
Associates (confirmed)
Anthony McQuillan, EMEAC Legal & Compliance, Vice
President, Medtronic (confirmed)
Thomas K. Hauser, Global Chief Compliance Officer, Siemens
Healthcare (confirmed)
Moderator: Dr. Adem Koyuncu, Partner - Lawyer and Medical
Doctor, Covington & Burling LLP (confirmed)
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 2,3)
‐
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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)
Alphie Moran, Senior Ethics, Compliance & Training
Officer - EMEA, Cook Medical (confirmed)
Moderator: Peter Ellingworth, Chief Executive, ABHI (confirmed)
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
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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
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)
Speakers:
‐ Annika Bien, Vice President, Law Department, Regulatory,
Pharma & Healthcare Strategies, Fresenius Medical Care
(confirmed)
‐ Anne-Sophie Bricca, Director Legal Affairs EMEA, Terumo
BCT (confirmed)
‐ Alan Howard, Senior Adviser for Strategy, Europa
Organisation (confirmed)
‐ Yuet Ming Tham, Partner, Sidley Austin (confirmed)
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)
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Rick Peterson, General Counsel, AAOS (confirmed)
Denis Jacob, Senior Commercial Assurance Manager, BD
(confirmed)
Daniel Waigl, Executive Director, CIRSE Central Office
(confirmed)
Adrian Ott, Chief Executive Officer, EFFORT (confirmed)
Moderator: Michael George, Corporate Communications Director
EMEA, Edwards Lifesciences (confirmed)
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:
(Thalia 1)
Speakers:
Best practices in distributors due diligence
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‐
‐
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Karl Boonen, Senior Director Business Practices and
Compliance EMEA & Canada, Johnson & Johnson
(confirmed)
Carolyn Bruguera, Vice President, Consulting Services, RSquared (confirmed)
Jamie Leitner, International Compliance Manager, Sorin
(confirmed)
Mariusz Witalis, Partner, Ernst & Young Business Advisory
(confirmed)
Moderator: Scott Lane, Executive Chairman, Red Flag Group
(confirmed)
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)
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Karen Hackett, CEO, AAOS (confirmed)
Isabel Bardinet, CEO, ESC (confirmed)
Carol Fitzpatrick, Chief Executive Officer, ESCRS (confirmed)
Dr. Chrysoula Nikolaou, Professor, Medical Biopathologist –
Neuroimmunologist, National University of Athens, Director,
Department of Medical Biopathology and Immunology,
Aeginition Hospital – Athens Medical School (confirmed)
Moderator: Dany Peters, Group Director Global Surgery, EMEA,
Education Solutions, Johnson & Johnson (confirmed)
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
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
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