May 2nd - 4th, 2018

Paris, France

#GMTCC

2015 Programme - Athens

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Tuesday 19 May

TimeProgramme
08.00 - 17.00Global Medical Technology Alliance (GMTA) - Members only
10.00 - 17.00Greek Distributor Training (SEIV) (in Greek) - Download agenda
10.00 - 12.30AdvaMed Device and Diagnostics Compliance Group (DDCG) - Members only
10.00 - 12.30MedTech Europe Compliance Network (CN) - Members only
12.30 - 13.45Joint DDCG - CN - GMTA - SEIV Lunch
13.45 - 17.00Joint DDCG - CN session - Members only
18.00 - 19.00PwC Compliance Achievement Award & Networking Cocktail

Wednesday 20 May

TimeProgramme
07.30Registration and welcome coffee
09.00 - 09.30Welcome address by Paul Arnaoutis - SEIV
09.30 - 10.45

Plenary session: Anti-corruption, business ethics, innovation & partnerships: A governmental perspective

Speaker:

  • 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, Director, TI-UK’s Business Integrity Programme (confirmed)
  • Bram van Houten, Policy Officer, Ministry of Health, Welfare and Sport (confirmed)

Moderator: Kathleen Hamann, Partner, White and Case

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 and current trends.

10.45 - 11.15

Networking break

11.15 - 12.30

Parallel session 1: Expert panel on distributor-related issues: “How Would Experts Manage this Distributor Compliance Scenario

Speaker:

  • 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?

Speakers:

  • 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, Spectranetics

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?

Speakers:

  • Arthur Muratyan, ETHICS (confirmed)
  • Kathleen M. Boozang, Associate Dean for Academic Advancement & Professor of Law, Seton Hall University School of Law (confirmed)
  • Roeland Van Aelst, VP Health Care Compliance EMEA & Canada, Johnson & Johnson
  • 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 profession, 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?

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).

Speakers:

  • Thomas Schumacher, Vice President, Ethics & Compliance, Medtronic (confirmed)
  • Heidi Jauch, Vice President, Compliance Officer EMEA, 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

12.30 - 13.45

Networking lunch

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)

Moderator: Mike Koon, Partner, Norton Rose Fulbright (confirmed)

  • 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 EMEA-APAC, 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

15.45 - 16.00

Plenary session: “Public Perception and Media”? Views on MedTech business ethics

SpeakerPeter O'Donnell, Associate Editor, POLITICO (confirmed)

16.00 - 17.00

Plenary session: CEO Roundtable on Global Compliance  

Speakers:

  • 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: 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.

18.30 - 20.00

Cocktail reception - Sponsored by EY

Thursday 21 May

TimeProgramme
07.00

Registration and welcome coffee

08.45 - 10.00

Plenary session: Direct and indirect sponsorship of HCPs to third-party organized conferences: Global trends and challenges

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 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.

10.00 - 11.00

Plenary session: Exchange of best practices: Meeting the challenges of the transition towards an “indirect-only-sponsorship” model

Speakers

  • 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)

ModeratorAdem 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

11.30 - 12.35

Parallel session 1: Local implementation of the EDMA/Eucomed “Direct Sponsorship Phase-out” recommendation: Challenges for national associations in Europe

Speaker:

  • 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 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?

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)

ModeratorRobert 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

Speaker:

  • 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, EFORT (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: Best practices in distributors due diligence

Speaker:

  • Karl Boonen, Senior Director Business Practices and Compliance EMEA & Canada, Johnson & Johnson (confirmed)
  • Carolyn Bruguera, Vice President, Consulting Services, R-Squared (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)

12.35 - 13.35

Networking lunch

13.35 - 14.50

Plenary session: Moving to new models of support for medical education: Considerations from physicians and scientific societies

Speakers:

  • 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)

ModeratorDany 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

Sinéad Keogh, Director, Irish Medical Devices Assosication (IMDA) (confirmed)