BRONZE GRANTORS:

CONTINUING EDUCATION CREDITS:Accounting Professionals: Approved for up to 19 NASBA CPE credits.

Attorneys: Pending approval for PA MCLE credits.

Compliance Professionals: Pending Compliance Certification Board (CCB) approval of CEUs.

www.InternationalPharmaCongress.com

SPONSOR:

MEDIA PARTNER:

SILVER GRANTORS:

The Fourteenth International Pharmaceutical and

Medical Device Ethics and Compliance Congress

CO CHAIRS:Anne-Sophie Bricca, MA, DEA International Law, DES Euro-pean Law, Deputy General Counsel & Senior Director Legal Affairs &

Compliance, Terumo BCT; Chair, Ethics and Com-pliance Group and Seats at the Code Committee, MedTech Europe, Brussels Area, Belgium

Stephen Nguyen Duc, Vice President, Global Head of Human Resources and Ethics & Compliance, Medday Pharmaceuticals; Board

Member, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France

CO SPONSORS:

KEYNOTE SPEAKERS:Gemma Aiolfi, Head of Compli-ance, Corporate Governance and Collective Action, Basel Institute on Governance; Former Advisor, Work-

ing Group on Bribery in International Business Transactions, Organisation for Economic Co-operation and Development, Basel, Switzerland

Julie Bonhomme, Legal & Compli-ance Director, European Federation of Pharmaceutical Industries and As-sociations (EFPIA), Brussels, Belgium

Robert I. Dodge, JD, Assistant Director, FCPA Unit, US SEC; Former Assistant US Attorney, US Attorney’s Office, Western District of Michigan, Washington, DC, USA

Roxana Family, Thèse de Doctorat Droit, Vice President, Chair in Law & Business Ethics and Program Director, Cergy Pontoise University, Cergy-Pontoise, France

Susanne Friedrich, MA, Director, Group Governance, Human Rights Division Global Policy, Governance, Alliance for Integrity, Bonn, Germany

David Fuhr, JD, Assistant Chief i n the FCPA Unit, US Department of Justice, Washington, DC, USA

Iordanis Kerenidis, PhD, Director, Paris Centre for Quantum Computing (PCQC), CNRS Senior Researcher (DR2), Algorithms

and Complexity Group, IRIF, University Paris Diderot, Paris, France

Aline Lautenberg, General Counsel and Director, Legal & Compliance, MedTech Europe, Brussels, Belgium

Sofie Melis, Head of Ethics and Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland

Hannes Oswald-Brugel, LLM, PhD, Global Head Pharma Health-care Compliance, Roche, Vice President, Association of Voluntary

Self-Regulation, for the Pharmaceutical Industry (FSA), Basel, Switzerland

Christoph Thalheim, Vice CEO and Director External Affairs, Eu-ropean Multiple Sclerosis Platform (EMSP), Brussels, Belgium

Dominique Laymand, Esq., Executive Vice President, Ethics & Social Responsibility, Ipsen; Honorary President, International

Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France

Roeland Van Aelst, EMEA Lead Third Party Intermediary Ethics and Compliance, Johnson & Johnson, Chairman, International

Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Chairman, MedTech Europe Code Committee, Brussels, Belgium

SHERATON MUNICH ARABELLAPARK HOTEL MUNICH, GERMANYAPRIL 20 – 22, 2020

FEATURING INVITATION-ONLY: CHIEF COMPLIANCE OFFICER ROUNDTABLE (Special April 20 Morning Invitation-only, Closed Session)

Featuring Sally Molloy, JD, Chief, Strategy, Policy & Training Unit, Fraud Section, Former Assistant US Attorney, US Attorney’s Office, Northern District of Georgia, US Department of Justice, Washington, DC, USA

For Early Bird Registration Discount

Register by Friday, March 20, 2020.

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WHO SHOULD ATTEND:• Pharmaceutical Manufacturers

• Medical Device Manufacturers

• Generic Pharmaceutical Manufacturers

• Site Management Organizations

• Clinical Research Organizations

• Management Companies

• Wholesale, Retail, Mail Order and Internet Pharmacies

• Health Care Regulators and Policy Makers

• Pharmaceutical and Health Care Executives and Board Members

• Regulatory and Compliance Professionals

• Medical Directors

• Physicians and Other Health Care Professionals

• Pharmacists

• Food and Drug Law Attorneys

• Health Care Attorneys and In-house Counsel

• Compliance Officers

• Privacy Officers

• Ethics Officers and Corporate Social Responsibility Personnel

• Pharmaceutical Consultants

• Investment Bankers

• Venture Capitalists

• Health Services Researchers and Academics

• Auditors

• Promotion Signatories/Approvers

• Risk Management Personnel

• Governmental Policy Makers and Regulators

SPONSOR:INTERNATIONAL SOCIETY OF HEALTHCARE ETHICS AND COMPLIANCE PROFESSIONALS (ETHICS) was incorporated as an Association governed by French law in January

2012, currently comprised of around 50 members all active in major pharma and medical device companies. ETHICS aims to be recognised as an independent international association of professionals, which sets standards of Ethics and Compliance and shapes and influences strategies in the changing Healthcare environment for the ultimate benefit of Patients and Society at large.

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S The International Pharmaceutical and Medical Device International Ethics & Compliance Con-gress is committed to the advancement of the industry’s ethics and compliance profession. The life sciences industry continues to be a highly-regulated and high-risk industry, and adherence

to applicable regulations and codes fosters a culture of “doing what is right”. This forum enables par-ticipants to keep their fingers on the pulse of enforcement trends, engage in interactive discussions, identify best practices, and explore how to operationalize innovative solutions.

We are excited to announce the Congress will offer two preconferences on the morning of Day I. The first is an invitation-only, closed-session Chief Compliance Officer Roundtable sponsored by ETHICS and co-sponsored by the International Federation of Pharmaceutical Manufacturers and Associa-tions (IFPMA), www.IFPMA.org, and MedTech Europe, www.MedTechEurope.org. The second is an interactive workshop on practical case studies built around analysis and codes-related education of the elements of an effective ethics and compliance program.

The Congress co-chairs are delighted to open Day I of the conference with our keynote speaker, Hani Abouhalka, MBA, Company Group Chairman, Medical Devices EMEA, Johnson & Johnson, who will address the evolution and future of the health care industry as a context to better prepare and shape the role of the ethics and compliance professional. Next, industry regulators and counsel will provide a comprehensive summary of the international anti-corruption landscape and the convergence of local legislation. Finally, senior compliance officers will discuss their compliance philosophy, gover-nance, culture, focus for the future and key challenges impacting their programs.

Day II opens on how to embed ethics in a company’s governance model and the value of having an ethical element on the Board and Executive Committees. Then listen as representatives provide updates on industry and regional codes. New this year, we are pleased to offer a new format for mini summits on relevant topics, which will engage faculty and attendees in interactive discussions and provide key take-aways to leverage in your programs.

The Day III closing plenary sessions address thought-provoking topics. Value based health care is a growing topic in both the pharmaceutical and medical devices industry that presents differ-ent challenges in the ethics and compliance space. Faculty will provide their perspective on what represents real value in a faster-changing health care environment, and their views on risk sharing models. Additional topics addressed include ethical interactions between the health care sector and emerging stakeholders, and the emergence of new technologies and artificial intelligence. The conference closes with an enthralling debate on the relationship between ethics & compliance and the implications for an effective compliance program. Learn the drivers for a sustainable ethical culture, including trust in business, the role of governance, trust in training and education, and trust in decision making with business partners.

We hope you will join our highly skilled faculty of experts from in-house compliance officers and counsel, regulators, trade association representatives and industry consultants and legal counsel as we share ideas on how to cultivate a culture of ethics and compliance with the highest integrity while networking with peers to build long lasting career relationships.

The First International Pharmaceutical Compliance Congress and Best Practices Forum was held in June 2007 to bring together company compliance professionals, regulators, lawyers, and consultants working in this interesting and expanding field. The purpose was to hold a truly global conference addressing the key issues impacting our industries. The first international conference agenda was developed with inputs from company compliance professionals on topics they wanted to know more about, which continues to be one of the greatest strengths of these conferences. Over the years, the International Congresses have been held in Berlin (2010), Brussels (2007, 2015), Budapest (2012), Dubai (2014), Istanbul (2011), Madrid (2013), Paris (2008), Rome (2009), Warsaw (2016), Lisbon (2017), Vienna (2018) and Athens (2019). In 2020, we are pleased to hold the Fourteenth Interna-tional Pharmaceutical and Medical Device Ethics and Compliance Congress in Munich, Germany.

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EXHIBIT AND SPONSORSHIP OPPORTUNITIES Take advantage of this unique opportunity to expand your reach! The Congress is attended by highly influential and experienced professionals. Sponsorship offers you strategic positioning as an industry leader. For more information call 206-673-4815 or email exhibits@hcconferences.com.

AGENDA AT A GLANCEMONDAY, APRIL 20

ETHICS WORKSHOP ON PRACTICAL ETHICS & COMPLIANCE CASE STUDIES

PRECONFERENCE SYMPOSIA

TUESDAY, APRIL 21DAY II: MORNING PLENARY SESSION • Embedding Ethics in a Company Governance Model• Global Compliance Codes UpdateMINI SUMMITS• I: Compliance Considerations for Small to Mid-Sized Organizations• II: Annual Medical Device Compliance Roundtable• III: Interconnectivity of Auditing, Monitoring, and Investigations• IV: Annual Central and Eastern Europe (CEE) Compliance Update• V: Best Practices for Compliance Training• VI: How to Build and Manage Compliance Risk Assessments• VII: Handling Ethics & Compliance When Interacting with 3rd Parties• VIII: Technology and AI to Prevent and Detect Corruption and Kickbacks• IX: Challenges and/or Considerations When Performing a Fair Market Value (FMV) Analysis• X: Compliance Considerations for Gene Therapy and Rare Disease Products• XI: GDPR and the Tumultuous World of Data Privacy• XII: Ethics and Compliance Issues in Patient Relationships, Including Patient Access and Support• XIII: Enhanced Compliance Monitoring• XIV: Building Effective and Right Sized Compliance Programs• XV: Role of Compliance Officers in Complex Global Organizations

AFTERNOON PLENARY SESSION • Value-Based Proposition• Ethical Interactions between Health Care & Other Stakeholders• Artificial Intelligence and Digital Health

DAY I: OPENING PLENARY SESSION • Congress Welcome, Vision and Overview• Keynote Address: Ethics, Compliance and the C-Suite• International Anti-Corruption Landscape• Senior Ethics & Compliance Professionals Roundtable

WEDNESDAY, APRIL 22MINI SUMMITS • XVI: Annual Middle East Africa (MEA) Compliance Update• XVII: The Role of the Industry re: Medical Education• XVII: EU Whistleblower Directive

CLOSING PLENARY SESSION

• Drivers for a Sustainable Ethical Culture• Trust in Business• The Role of Governance• Co-chair Congress Highlights & Key Points

CLOSED-DOOR, INVITATION-ONLY CHIEF COMPLIANCE OFFICER ROUNDTABLE

HOTEL INFORMATION/RESERVATIONSThe International Pharmaceutical and Medical Device Ethics & Compliance Congress does not contract with any third party organization to make hotel reservations for attendees of the Summit. All attendees should make their hotel reservations directly with the hotel and not with a third party vendor.

The Sheraton Munich Arabellapark Hotel in Munich, Germany is the official hotel for The International Pharmaceutical and Medical Device Ethics & Compliance Congress.

A special group rate of €184.00 sgl/€209.00 dbl per night (plus applicable taxes) has been arranged for Congress Attendees. To make your reservation, please email Reservierung.arabellapark@marriott.com using the confer-ence name and rate as their reference. Reserved rooms may be cancelled until April 8, 2020 without charge. After that date there will be a cancella-tion fee of 90% of the total value of their stay. Please make sure of your plans prior to this date to avoid the cancellation fee. Reservations at the group rate will be accepted while rooms are available.

Sheraton Munich Arabellapark HotelArabellastrasse 5 81925 Munich, Germany tel: +49 (0)89 9232 0

www.sheratonarabellapark.com

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MONDAY, APRIL 20, 20207:00 am Registration Opens and Networking Breakfast

PRECONFERENCE SYMPOSIA (Optional, Choose only one)

PRECONFERENCE I: CHIEF COMPLIANCE OFFICER ROUNDTABLE No-cost, Closed-Door, Invitation-Only Sponsor: International Society of Healthcare Ethics and Compliance Professionals (ETHICS)

Co-sponsors: International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and MedTech Europe

8:00 am Networking Buffet Breakfast Hosted by ETHICS

Welcome & Introductions

Association UpdatesIFPMASofie Melis, Head of Ethics and Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland

EFPIAJulie Bonhomme, EFPIA Legal and Compliance Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium

MedTech EuropeAline Lautenberg, General Counsel and Director, Legal and Compliance, MedTech Europe, Brussels, Belgium

Update on US DOJ Evaluation of Corporate Compliance Program GuidanceSally Molloy, JD, Chief, Strategy, Policy and Training Unit, Fraud Section; Former Assistant US Attorney, US Attorney’s Office, Northern District of Georgia, US Department of Justice, Washington, DC, USA

Strategic Discussion with Board of DirectorsThomas Costa, JD, Member, US Board of Directors, Sanofi; Former Vice President, US Compliance and Ethics, Bristol-Myers Squibb, Washington, DC, USA

Open Discussions

12:00 pm Adjournment and Lunch on Your Own

PRECONFERENCE II: A WORKSHOP ON PRACTICAL CASE STUDIES AND EXERCISES IN ETHICS AND COMPLIANCESponsored by International Society of Healthcare Ethics and Compliance Professionals (ETHICS)

8:00 am Welcome & Introductions Pablo Rojas Abad, LLM, Manager, Legal and Compliance, MedTech Europe, Brussels, Belgium

Sue Egan, Director and Principal Consultant, Sue Egan Associates; Former Vice President, Compliance, AstraZeneca, Great Missenden, Buckinghamshire, UK

Hannes Oswald-Brugel, LLM, PhD, Global Head Pharma Healthcare Compliance, Roche; Vice President, Association of Voluntary Self-Regulation for the Pharmaceutical Industry (FSA), Basel, Switzerland

Karen Eryou, Head, Ethics and Compliance Programs, Global, UCB Pharma; Former Co-chair, Asia Pacific Pharma Compliance Congress, Brussels, Belgium (Discussion Coordinator)

8:15 am Case Study 1: Interactions with HCPs — Meetings, Sponsorship and Fees for Services

9:15 am Case Study 2: Interacting with Patient Organizations and Patients

10:15 am Break

10:30 am Case Study 3: Effective Management of Third Parties

11:15 am Case Study 4: New Technologies • Gene Editing • Mobile App

12:00 pm Adjournment and Lunch on Your Own

MONDAY, APRIL 20, 2020

DAY I: OPENING PLENARY SESSION1:00 pm Welcome to The International Pharmaceutical and Medical Device Ethics & Compliance Congress

Hannes Oswald-Brugel, LLM, PhD, Global Head Pharma Healthcare Compliance, Roche; Vice President, Association of Voluntary Self-Regulation for the Pharmaceutical Industry (“FSA”), Basel, Switzerland

1:15 pm International Pharmaceutical and Medical Device Ethics & Compliance Congress Vision and Overview

Anne-Sophie Bricca, MA, DEA International Law, DES European Law, Deputy General Counsel and Senior Director, Legal Affairs and Com-pliance, Terumo BCT; Board Member and Co-chair, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS); Chair, Ethics and Compliance Group and Member Code Committee, MedTech Europe, Brussels, Belgium

Stephen Nguyen Duc, Vice-President, Global Head of Human Resources and Ethics and Compliance, Medday Pharmaceuticals; Board Member and Co-chair, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France

Dominique Laymand, Esq., Executive Vice President, Ethics & Social Responsibility, Ipsen; Honorary President, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Paris, France

Roeland Van Aelst, EMEA Lead Third Party Intermediary Ethics and Compliance, Johnson & Johnson; Chairman, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS); Chairman, MedTech Compliance Network, Brussels, Belgium

1:30 pm Keynote Address: Industry Executive

Hani Abouhalka, MBA, Company Group Chairman, Medical Devices EMEA, Johnson & Johnson, New Brunswick, NJ, USA

2:00 pm International Anti-Corruption Landscape French Anticorruption Law Update

George Fife, Partner, Forensic & Integrity Services, EY, Paris, France

Pascale Paimbault, Chief Executive Officer, Consulting Alley; Strategic Committee Member, ETHICS; Former Executive Director, EMEA Compliance Astellas Pharma Inc.; Former Compliance Officer, France -Benelux, Biogen; Former Chief Compliance Officer EMEA, Wright Medical Inc.; Former Senior Director, EMEA, Bristol-Myers Squibb, Paris, France

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US FCPARobert I. Dodge, JD, Assistant Director, FCPA Unit, US Securities and Exchange Commission; Former Assistant U.S. Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmen-tal Defense Section, US Department of Justice, Washington, DC, USA

David Fuhr, JD, Assistant Chief in the FCPA Unit, US Department of Justice, Washington, DC, USA

Gary F. Giampetruzzi, JD, Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA

3:30 pm Break

4:00 pm International Anti-Corruption Landscape (Continued) Asia Pac Update

Lei Li, LLM, Managing Partner, Beijing and Shanghai Offices, Sidley Austin; Former Third Secretary, Ministry of Commerce, People’s Republic of China, Beijing, China

EU/CEE Updates Peter Dieners, Esq., Partner and Head, Global Healthcare and Life Sciences Group, Clifford Chance; Co-chair, Legal Affairs Focus Group (LA FG), EUCOMED; Co-chair, Compliance Network (CN), EUCOMED, Düsseldorf, Germany

Paul J. Melling, Esq., Founding Partner, Baker & McKenzie - CIS, Limited, Moscow, Russia

OECD Anti-Bribery UpdateGemma Aiolfi, Head of Compliance, Corporate Governance and Collective Action, Basel Institute on Governance; Former Advisor, Working Group on Bribery in International Business Transactions, Organisation for Economic Co-operation and Development (OECD); Former Legal Counsel to the Integrity Department and Internal Office of Special Investigations, ABB AG, Oerlikon Zurich; Former Global Head of Anti-Corruption, UBS AG, Basel, Switzerland

Overall Discussion CoordinatorMichael K. Loucks, JD, Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice, Washington, DC, USA

5:00 pm Senior Ethics & Compliance Professionals Roundtable

Dante Beccaria, Global Compliance Officer and Vice President, Sanofi; Former Vice President of Internal Audit, Sanofi; Former Co-chair, International Pharmaceutical and Medical Device Compliance Congress, Paris, France

Anne-Sophie Bricca, MA, DEA International Law, DES European Law, Deputy General Counsel and Senior Director, Legal Affairs and Com-pliance, Terumo BCT; Board Member and Co-chair, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS); Chair, Ethics and Compliance Group and Member Code Committee, MedTech Europe, Brussels, Belgiumm

Hannes Oswald-Brugel, LLM, PhD, Global Head Pharma Healthcare Compliance, Roche; Vice President, Association of Voluntary Self-Regulation for the Pharmaceutical Industry (“FSA”), Basel, Switzerland

Pascale Schmidt, Chief Compliance Officer, F. Hoffmann-La Roche Ltd, Basel, Switzerland

Tom Gregory, MBA, Partner, Forensic & Integrity Services, EY, Atlanta, GA, USA (Discussion Coordinator)

6:00 pm Adjournment and Networking Reception

TUESDAY, APRIL 21, 20207:30 am Registration Commences

DAY II: MORNING PLENARY SESSION 8:00 am Co-Chair Welcome and Overview

8:15 am Value of Embedding Ethics in a Company Governance Model

Parth Chanda, JD, MPA, Founder and CEO, Lextegrity; Former Chief Compliance Counsel, Oncology, Pfizer, New York, NY, USA

Thomas Costa, JD, Member, US Board of Directors, Sanofi; Former Vice President, US Compliance and Ethics, Bristol-Myers Squibb, Washington, DC, USA

Dominique Laymand, Esq., Executive Vice President, Ethics and Social Responsibility, Ipsen; Honorary President, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Paris, France

Piergiorgio Pepe, MA, EU Law, President, Quantum Ethics, Ethics and Compliance Lecturer, SciencesPo; Former Compliance Director, Western Europe & Canada, AbbVie; Former Director, Compliance and Ethics EMEA, Bristol-Myers Squibb, Paris, France (Discussion Coordinator)

9:00 am Global Compliance Codes Update IFPMA

Sofie Melis, Head of Ethics and Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland

EFPIA Julie Bonhomme, EFPIA Legal and Compliance Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium

MedTech EuropeAline Lautenberg, General Counsel and Director, Legal and Compliance, MedTech Europe, Brussels, Belgium

MEALaura Nassar, Vice President, Head of Ethics and Business Integrity, AEME Region, Sanofi; Former Head of Compliance Middle East, Roche Pharmaceuticals; Former Regional Pharma HCC Officer, Emerging Markets, Johnson & Johnson, Beirut, Lebanon

Asia PacLei Li, LLM, Partner, Sidley Austin; Former Third Secretary, Ministry of Commerce, People’s Republic of China, Beijing, China

Holger Diener, Managing Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry (“FSA”); Member, Ethics and Compliance Committee and Vice Chair, Code Committee, EFPIA; Member, IFPMA Code Compliance Network, Berlin, Germany (Discussion Coordinator)

10:30 am Break

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MINI SUMMITS ROUND I 11:00 am – Noon

MINI SUMMIT I: Compliance Considerations for Small to Mid-Sized Organizations11:00 am Introductions, Interactive Discussion & Key Points Rosa Magistri, CIPP/E, Head of Legal and Compliance Europe, SeaGen International GmbH; Former Regional Director, Office of Ethics and Compliance, Western Europe & Canada, Region South & Israel, AbbVie; Former Associate Compliance Director, Shire, Zug, Switzerland

Stephen Nguyen Duc, Vice President, Global Head of Human Resources and Ethics and Compliance, Medday Pharmaceuticals; Board Member and Co-chair, Strategic Committee, In-ternational Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France

Madina Torchinova, Vice President, Deputy Head Global Compliance, MorphoSys; Former Regional Head of Compliance, Central & Eastern Europe, Middle East & Africa, and Global OTC, Sandoz, Munich, Germany Mario Prohasky, Global Compliance Consultant, IQVIA, London, UK (Discussion Coordinator)

MINI SUMMIT II: Annual Medical Device Compliance Roundtable11:00 am Introductions, Interactive Discussion & Key Points Pablo Rojas Abad, LLM, Manager, Legal and Compliance, MedTech Europe, Brussels, Belgium

Tamara Tubin, International Compliance Director, Corporate Compliance, Wright Medical Group N.V.; Vice Chair, Ethics and Compliance Committee, MedTech Europe; Board Member, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Zürich, Switzerland

Roeland Van Aelst, EMEA Lead, Third Party Intermediary Ethics and Compliance, Johnson & Johnson; Chairman, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS); Chairman, MedTech Compliance Network, Brussels, Belgium

Christopher L. White, JD, Chief Operating Officer and General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC, USA

Elisabethann Wright, LLB, Partner, Hogan Lovells; Former Senior Legal Officer and Hearing Officer, EFTA Surveillance Authority, Brussels, Belgium (Discussion Coordinator)

MINI SUMMIT III: Interconnectivity of Auditing, Monitoring, and Investigations11:00 am Introductions, Interactive Discussion & Key Points Keith Burn, Global Investigations Director, Ipsen; Former Associate Investigator, Parliamentary and Health Service Ombudsman, NHS; Former Detective Constable, London Metropolitan Police, Amersham, Slough, UK

Gary F. Giampetruzzi, JD, Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA

Betania Glorio, LLM, Global Compliance Officer, Healthcare, Merck KGaA; Former Senior Director, Legal and Compliance EMEA, Horizon Pharma plc and Raptor Pharmaceuticals, Darmstadt, Germany

Franziska Janorschke, Global Head, Business Practices Office, Novartis International AG, Basel, Switzerland

Enno Behrendt, Associate Director, Guidehouse; Former Head of Compliance for Diagnostic Imaging, Siemens Healthcare GmbH, Berlin, Germany (Discussion Coordinator)

MINI SUMMIT IV: Annual Central and Eastern Europe (CEE) Compliance Best Practices Update 11:00 am Introductions, Interactive Discussion & Key PointsNatalie Ammerlaan, LLM, Compliance Director International Operations, Novo Nordisk, Zürich, SwitzerlandDuygu Beyazo, Senior Associate, NSN Law Firm; Former Compliance Manager (Secondment), Business Conduct, Gilead Sciences, Istanbul, Turkey Tomasz Kruk, LLM, MBA, Head of Compliance, Vifor Pharma; Former Director International Compliance, Mallinckrodt; Former Director Global Ethics and Compliance, Actavis, Zürich, Switzerland

Leonardo Silva, LLM, Vice President, Global Chief Compliance and Privacy Officer, Ferring Pharmaceuticals; Former Head of Compliance, Acino Group; Former Compliance Director, Emerging Markets, Takeda, Lausanne, SwitzerlandPaul J. Melling, JD, Founding Partner, Baker & McKenzie, CIS, Limited, Moscow, Russia (Co-Discussion Coordinator)Mariusz Witalis, Partner, Forensic & Integrity Services, EY, Warsaw, Poland (Co-Discussion Coordinator)

MINI SUMMIT V: Best Practices for Compliance Training11:00 am Introductions, Interactive Discussion & Key Points Edoardo Lazzarini, PhD, Healthcare Compliance Consultant; Former EuCan Ethics and Compliance Initiatives Director, Takeda Pharmaceuticals; Former Compliance Officer EMEA (Europe, Middle East & Africa), Zimmer Biomet, Milan, ItalyMarcel Maderitsch, LLM, Senior Compliance Officer, Vifor Pharma; Former Compliance Manager EMEA, Zimmer Biomet, Zurich, SwitzerlandNadège Rochel, Global Compliance Manager, Hollister Incorporated, Milan, Italy Robert Stephenson, Senior Manager, PwC UK,, London, UK (Discussion Coordinator)

Noon NETWORKING LUNCHEON

MINI SUMMITS ROUND II 1:00 pm – 2:00 pm

MINI SUMMIT VI: How to Build and Manage Healthcare Compliance Risk Assessments1:00 pm Introductions, Interactive Discussion & Key Points Karen Eryou, Head, Ethics and Compliance Programs, Global, UCB Pharma; Former Co-chair, Asia Pacific Pharma Compliance Congress Brussels, BelgiumLauri G. Opar, Director, Risk Analytics, Global Ethics and Compliance, Glaxosmithkline, Brentford, Middlesex, UKMadina Torchinova, Vice President, Deputy Head Global Compliance, MorphoSys; Former Regional Head of Compliance, Central & Eastern Europe, Middle East & Africa, and Global OTC, Sandoz, Munich, Germany J. Mark Farrar, MSJ, CPA, CFE, CFF, Partner, Life Sciences Governance, Risk Management and Compliance, Guidehouse, Atlanta, GA, USA (Discussion Coordinator)

MINI SUMMIT VII: How to Effectively Handle Ethics and Compliance When Interacting with Third Parties1:00 pm Introductions, Interactive Discussion & Key Points Kara Bonitatibus, JD, Head of Product, Lextegrity; Former Assistant General Counsel, Compliance Lead for Digital, Policy, and Patient & Health Impact, Pfizer, New York, NYAlex Fell, Head, Ethics and Compliance International; Amicus Therapeutics; Former Vice President, Global Ethics and Compliance, Head of Strategy, Planning and Operations, GSK, London, UK Edoardo Lazzarini, PhD, Healthcare Compliance Consultant; Former EuCan Ethics and Compliance Initiatives Director, Takeda Pharmaceuticals; Former Compliance Officer EMEA (Europe, Middle East & Africa), Zimmer Biomet, Milan, Italy Roeland Van Aelst, EMEA Lead, Third Party Intermediary, Ethics and Compliance, Johnson & Johnson; Chairman, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS); Chairman, MedTech Compliance Network, Brussels, Belgium Alice Choy, MS, Manager, Anti-Bribery, Anti-Corruption (ABAC) Compliance, Internal Audit, Risk Assessment, IQVIA; Former Lead Specialist, Transparency and Reporting, Johnson & Johnson, London, UK (Discussion Coordinator)

MINI SUMMIT VIII: Technology and AI to Prevent and Detect Corruption and Kickbacks1:00 pm Introductions, Interactive Discussion & Key Points John Seungjoo Rah, JD, Partner, DLA Piper, Washington, DC

Piyush Sharma, JD, Senior Vice President, Deputy Chief Compliance Officer, International Compliance, Alexion Pharmaceuticals, New Haven, CT

Parth Chanda, JD, MPA, Founder and Chief Executive Officer, Lextegrity; Former Global Anti-Corruption Lead and Chief Compliance Counsel, Oncology, Pfizer; New York, NY (Discussion Coordinator)

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MINI SUMMIT IX: Challenges and/or Considerations When Performing a Fair Market Value (FMV) Analysis1:00 pm Introductions, Interactive Discussion & Key Points Peter Dieners, Esq., Partner and Head, Global Healthcare and Life Sciences Group, Clifford Chance; Co-chair, Legal Affairs Focus Group (LA FG), EUCOMED; Co-chair, Compliance Network (CN), EUCOMED, Düsseldorf, Germany

Pascale Schmidt, Chief Compliance Officer, F. Hoffmann-La Roche Ltd, Basel, Switzerland

Eric Bolesh, Chief Operating Officer, Cutting Edge Information, Raleigh-Durham, NC, USA (Discussion Coordinator)

MINI SUMMIT X: Compliance Considerations for Gene Therapy and Ultra Rare Disease Products1:00 pm Introductions, Interactive Discussion & Key Points Indrani M. Lall Franchini, JD, Executive Vice President & Chief Compliance Officer, Alexion Pharmaceuticals, Inc.; Former Assistant General Counsel, Pfizer, New York, NY, USA

Dominique Laymand, Esq., Executive Vice President, Ethics and Social Responsibility, Ipsen; Honorary President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France

Gary F. Giampetruzzi, Esq., Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA

Casey J. Horton, CFE, Director, Life Sciences, Governance, Risk and Compliance, Guidehouse, Chicago, IL (Discussion Coordinator)

2:00 pm Transition Break

MINI SUMMITS ROUND III 2:15 pm – 3:15 pm

MINI SUMMIT XI: GDPR and the Tumultuous World of Data Privacy2:15 pm Introductions, Interactive Discussion & Key Points Stefano Biondi, LLB, PhD, Group Data Protection Offcer, Menarini Group, Florence, Italy

Ariadna Quesada, MSJ, Law, Ethics and Compliance Officer, The Netherlands, AbbVie; Former Compliance Manager, International, MicroPort Orthopedics, Amsterdam, Netherlands

Giuseppe Saporito, LLM, Global Legal and Regulatory Expert, IQVIA, Milan, Italy

Elisabeth Kohoutek, Senior Associate, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, Germany (Discussion Coordinator)

MINI SUMMIT XII: Ethics and Compliance Issues in Patient Relationships, Including Patient Access and Support 2:15 pm Introductions, Interactive Discussion & Key Points Stephen Nguyen Duc, Vice President, Global Head of Human Resources and Ethics and Compliance, Medday Pharmaceuticals; Board Member and Co-chair, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France

Duygu Beyazo, Senior Associate, NSN Law Firm; Former Compliance Manager (Secondment), Business Conduct, Gilead Sciences, Istanbul, Turkey

Casey J. Horton, CFE, Director, Life Sciences, Governance, Risk and Compliance, Guidehouse, Chicago, IL (Discussion Coordinator)

MINI SUMMIT XIII: Enhanced Compliance Monitoring 2:15 pm Introductions, Interactive Discussion & Key Points Laura Coll Gil, LLM, Ethics and Compliance Officer, Boehringer Spain, Barcelona, Catalonia, Spain

Giota Papamarkou, Vice President, Business Ethics Global, France, Ipsen; Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, France

Pascale Paimbault, Chief Executive Officer, Consulting Alley; Strategic Committee Member, ETHICS; Former Executive Director, EMEA Compliance Astellas Pharma Inc.; Former Compliance Officer, France -Benelux, Biogen; Former Chief Compliance Officer EMEA, Wright Medical Inc.; Former Senior Director, EMEA, Bristol-Myers Squibb, Paris, France

Vanessa Westphal, JD, MS, Head of Compliance Programs & Support, Merck KGaA, Frankfurt Am Main Area, Germany

Anita Kyung-Hee Kim-Reinartz, Partner, Forensic & Integrity Services, EY, Düsseldorf, Germany (Discussion Coordinator)

MINI SUMMIT XIV: Building Effective and Right Sized Compliance Programs to Modernize your Compliance Program to Prepare for the Future of Health 2:15 pm Introductions, Interactive Discussion & Key Points Caroline Franco, MBA, Ethics and Compliance Manager, Boehringer Ingelheim, Amsterdam, Netherlands

Klaus Geldsetzer, MBA, Chief Compliance Officer EMEA, Santen GmbH; Chairman, Eye-Care Industries European Economic Interest Grouping; Former Head of R&D Office and Global Project Leader, Allergan Ltd Munich, Germany

Laetitia Ducroquet Minel, Senior Director, Business Ethics, Ipsen, Paris, France

Véronique Monjardet, MS, DEA, PhD, Sales Director, IQVIA, Paris, France (Discussion Coordinator)

MINI SUMMIT XV: The Role of Compliance Officers in Complex Global Organizations2:15 pm Introductions, Interactive Discussion & Key Points Michael Bartke, PhD, Member, Strategic Committee, ETHICS; Former Director Ethics and Compliance, Alexion; Former Director Compliance Management, Daiichi Sankyo Europe, Munich, GermanyDante Beccaria, Global Compliance Officer and Vice President, Sanofi; Former Vice President of Internal Audit, Sanofi; Former Co-chair, International Pharmaceutical and Medical Device Compliance Congress, Paris, France

Peter Dieners, Esq., Partner and Head, Global Healthcare and Life Sciences Group, Clifford Chance; Co-chair, Legal Affairs Focus Group (LA FG), EUCOMED; Co-chair, Compliance Network (CN), EUCOMED, Düsseldorf, Germany

Leonardo Silva, LLM, Vice President, Global Chief Compliance and& Privacy Officer, Ferring Pharmaceuticals; Former Head of Compliance, Acino Group; Former Compliance Director, Emerging Markets, Takeda, Lausanne, Switzerland

Oscar Perdomo, Director, Pharmaceutical & Life Sciences Advisory Services, PwC Switzerland, Zurich, Switzerland (Discussion Coordinator)

3:15 pm Break

AFTERNOON PLENARY SESSION 3:45 pm Value-Based Healthcare and Implications for Ethics and Compliance

Bas Amesz, Partner, Vintura, Baarn, Utrecht, Netherlands

Anthony McQuillan, LLB, Vice President, Legal and Compliance EMEA, Medtronic International; Former Senior Attorney EMEA, Hewlett-Packard, London, UK

Cláudia Vaz, Global Value-Based HealthCare Consultant, Roche; Value-Based Health Care Consultant, International Consortium for Health Outcomes Measurement (ICHOM), Basel, Switzerland

Adem Koyuncu, MD, PhD (Law), Partner and Chair, Food, Drug and Device Practice Group, Covington, Brussels, Belgium (Discussion Coordinator)

4:30 pm Ethical Interactions between the Health Care Sector and Other Stakeholders

Sadek Beloucif, MD, University Professor, Hospital Practitioner and Head of Anesthesia-Resuscitation, University of Paris and University Hospital, Bobigny; Chair, National Union of Physicians, Surgeons, Specialists, and Biologists of Public Hospitals, Paris, France

Christian-Claus Roth, Head Scientific Engagement Governance at Novartis, Basel, Switzerland

Christoph Thalheim, Vice CEO and Director External Affairs, European Multiple Sclerosis Platform (EMSP), Brussels, Belgium

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5:15 pm Artificial Intelligence and Digital Health Julien Durand, MBA, PhD, Vice President, Head of Transformation, Global Ethics and Compliance, Takeda; Chair, IFPMA Future Health Technologies & Bioethics Working Groups; Former Executive Director, Compliance and Ethics, Amgen; Former Chief Privacy Officer and Global Technology Compliance Head, AstraZeneca, Zürich, Switzerland

Abhiroop Gandhi, Trust and Compliance Officer, Verily Life Sciences (an Alphabet company); Former Vice President, Corporate Compliance, Mallinckrodt, San Francisco, CA, USA

Mirgen Jaku, MA, Lead of Market Readiness, Digital Surgery, EMEA, Johnson & Johnson, Hamburg, Germany

Iordanis Kerenidis, PhD, Director, Paris Centre for Quantum Computing (PCQC), CNRS Senior Researcher (DR2), Algorithms and Complexity Group, IRIF, University Paris Diderot, Paris, France

Anne-Sophie Bricca, MA, DEA International Law, DES European Law, Deputy General Counsel and Senior Director, Legal Affairs and Com-pliance, Terumo BCT; Board Member and Co-chair, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS); Chair, Ethics and Compliance Group and Member, Code Commit-tee, MedTech Europe, Brussels, Belgium (Discussion Coordinator)

6:00 pm ADJOURNMENT

WEDNESDAY, APRIL 22, 20207:30 am Registration Commences

DAY III: MINI SUMMITS AND CLOSING PLENARY SESSION

MINI SUMMITS ROUND IV 8:30 am – 9:30 am

MINI SUMMIT XVI: Annual Middle East Africa (MEA) Compliance Update 8:30 am Introductions, Interactive Discussion & Key PointsEls Janssens, LLM, Associate, Baker & McKenzie; Former Legal Adviser, European Medicines Agency; Former Senior Legal Counsel, Johnson & Johnson, Brussels, Belgium

Samar Wakim, PharmD, Ethics, Risk and Compliance Head MEA, Oncology, Novartis, Dubai, UAE

Joseph W. Henein, PharmD, President and Chief Executive Officer, NewBridge Pharmaceuticals, Dubai, UAE (Co-Discussion Coordinator)

Laura Nassar, Vice President, Head of Ethics and Business Integrity, AEME Region, Sanofi; Former Head of Compliance Middle East, Roche Pharmaceuticals, Former Regional Pharma HCC Officer, Emerging Markets, Johnson & Johnson, Beirut, Lebanon (Co-Discussion Coordinator)

MINI SUMMIT XVII: The Role of the Industry re: Medical Education — Trends and Aspects8:30 am Introductions, Interactive Discussion & Key PointsMichael Bartke, PhD, Member, Strategic Committee, ETHICS; Former Director Ethics and Compliance, Alexion; Former Director Compliance Management, Daiichi Sankyo Europe, Munich, GermanyHolger Diener, Managing Director, Association of Voluntary Self-Regulation for the Phar-maceutical Industry (“FSA”); Member, Ethics and Compliance Committee and Vice Chair, Code Committee, EFPIA; Member, IFPMA Code Compliance Network, Berlin, Germany

Bruno Lichtinger, Managing Director, INTERPLAN Congress, Meeting & Event Management AG, Munich, Germany

Christian-Claus Roth, Head Scientific Engagement Governance, Novartis, Basel, Switzerland

Liisa Eisenlohr, PhD, MBA, CCRA, BCMAS, Associate Director, Guidehouse; Former Senior Director, Global Medical Information, Clovis Oncology, London, UK (Discussion Coordinator)

MINI SUMMIT XVIII: EU Whistleblower Directive8:30 am Introductions, Interactive Discussion & Key Points Betania Glorio, LLM, Global Compliance Officer, Healthcare, Merck KGaA; Former Senior Director, Legal and Compliance EMEA, Horizon Pharma plc and Raptor Pharmaceuticals, Darmstadt, Germany

Elisabeth Kohoutek, Senior Associate, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, Germany

Ulf H. Grundmann, Partner, FDA and Life Sciences, King & Spalding LLP; Lecturer, Frankfurt School of Finance and Management, Frankfurt am Main, Germany (Discussion Coordinator)

9:30 am Transition Break

CLOSING PLENARY SESSION 10:00 am Co-Chair Introductions

10:15 am Drivers for a Sustainable Ethical Culture Keynote

Piergiorgio Pepe, MA, EU Law, President, Quantum Ethics, Ethics and Compliance Lecturer, SciencesPo; Former Compliance Director, Western Europe & Canada, AbbVie; Former Director, Compliance and Ethics EMEA, Bristol-Myers Squibb, Paris, France (Discussion Coordinator)

Trust in BusinessRoxana Family, Thèse de Doctorat Droit, Vice President, Chair in Law and Business Ethics and Program Director, Cergy Pontoise University, Cergy-Pontoise, France

The Role of GovernanceSusanne Friedrich, MA, Director, Group Governance, Human Rights Division Global Policy, Governance Alliance for Integrity (AfIn), Bonn, Germany

Trust in Decision Making: Compliance Coordinates with Business Partners

Bella Hovhannisyan, Business Integrity and Compliance Lead, Intercontinental Commercial Operations, CSL Behring, Bern, Switzerland

Trust in Training and EducationMatteo Santi, Group Compliance Officer, Helsinn Healthcare, Ticino, Switzerland

Noon Co-Chair Congress Highlights & Key Points

12:15 pm ADJOURNMENT

November 4 – 6, 20209 Mandarin Oriental Washington, DC

A HYBRID CONFERENCE AND INTERNET EVENT

Twenty-First Annual Pharmaceutical and

Medical Device Compliance Congress

SAVE THE DATE

SPONSORED BY: MEDIA PARTNERS:

www.PharmaCongress.com

TYPES OF MEMBERSHIP CATEGORIESFOUNDING MEMBERS: The founding members are Dominique Laymand and Roeland van Aelst.

CONTRIBUTING MEMBERS: Individuals able to help the Association through payment of a special annual subscription fee.

ACTIVE MEMBERS: Individuals ready to demonstrate and implement a positive contribution to the Association’s purpose and take part actively in its works and activities.

HONORARY MEMBERS: Nominated (by the Board) as result of services rendered to the Association, or in consideration of their particular skills or expertise in the domain of Compliance or Ethics.

“At a time when Compliance, Ethics and Business Integrity have never been so crucial for all industries, my colleagues and I are proud to have created this Association which is comprised of leading professionals responsible for Compliance and Ethics in major Pharmaceuticals and Medical Devices Companies” —Dominique Laymand, Honorary President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS) SEE http://www.ethicspros.com/how-to-join/types-of-members/.

MEMBERSHIP APPLICATION FORMThank you for your interest in ETHICS. If you wish to join our society, please complete the form below and also email your CV to: bureau@ethicspros.com.

The ETHICS Bureau meets regularly to consider membership applications and we normally aim to respond to prospective members within three weeks, although during holiday periods our response may take a little longer.

You can also apply online at:  www.ethicspros.com. Required fields are marked *

Name *  

Telephone   Email *  

Company  Position

Local Chapter Country (if applicable) 

Please specify the membership category you would like to apply for: o Contributing member: €1,500 o Active Member: €250 Please  briefly describe your experience in ethics and compliance roles, including function and reporting line, and your current role: *

 

What  is  your  level  of  Seniority  in  your  current  position? *  

How did you learn about our Association? *

SEE http://www.ethicspros.com/how-to-join/membership-application/.

PAYMENTSAll payments must be made in Euros. Payments are only accepted through credit card and bank transfer. A person will not be deemed to be formally registered until payment in full has been received. To receive the early bird discount, payment must be received by the early bird date. All payments must be made within 10 days of registration in order to reserve your seat at the conference. Delegates with outstanding payment balances will be asked for payment on site, proof of payment or a guarantee by credit card. Seating will be subject to availability.

PRO FORMA INVOICESComplete one of the online forms and generate a Pro Forma Invoice, or fill out the downloadable form to email, fax, or mail in your request for a Pro Forma Invoice. For questions about the registration process, contact the Registration Office at 1-800-503-8171 and 1-206-452-5528, or send an email to registration@hcconferences.com.

REGARDING ONSITE REGISTRATION, CANCELLATIONS AND SUBSTITUTIONS1. For onsite group registrations, full registration and credit card informa-tion is required for each registrant. List all members of groups registering concurrently on fax or scanned cover sheet.2. For onsite registrants there will be no refunds for “no-shows” or for cancellations. You may send a substitute. Please call the Conference Office at 1-800-503-8171 or 1-206-452-5528 for further information.

METHOD OF PAYMENT FOR TUITIONMake payment to Health Care Conference Administrators LLC by MasterCard, Visa or American Express. Credit card charges will be listed on your statement as payment to HealthCare (HC) Conf LLC.

REGISTRATION OPTIONSRegistration may be made online or via mail, fax or scan.You may register through either of the following: • Online at www.InternationalPharmaCongress.com.• Fax/Mail/Email using this printed registration form. Mail the completed form with payment to the Conference registrar at 12320 NE 8th Street, Suite 201, Bellevue, WA 98005, USA, or fax the completed form to 1-206-319-5303, or scan and email the completed form to registration@hcconferences.com. The following credit cards are accepted: American Express, Visa or Master-Card. Credit card charges will be listed on your statement as payment to HealthCare (HC) Conf LLC.For registrants awaiting company bank transfer, a credit card number must be given to hold registration. If payment is not received by seven days prior to the Congress, credit card payment will be processed.

TAX DEDUCTIBILITYExpenses of training including tuition, travel, lodging and meals, incurred to maintain or improve skills in your profession may be tax deductible. Consult your tax advisor. Federal Tax ID: 91-1892021.

CANCELLATIONS/SUBSTITUTIONSNo refunds will be given for “no-shows” or for cancellations. You may send a substitute. Please call the Conference Office at 1-800-503-8171 and 1-206-452-5528, or send an email to registration@hcconferences.com.

INTELLECTUAL PROPERTY POLICYUnauthorized sharing of Congress content via Webcast access through the sharing of user names and passwords or via alternative media (Flash Drive)

through the sharing of said media is restricted by law and may subject the copyright infringer to substantial civil damages. The Congress aggressively pursues copyright infringers. If a registrant needs the ability to share Con-gress content within his or her organization, multiple Congress registrations are available at discounted rates.

The Congress will pay a reward for information regarding unauthorized sharing of Congress content. The reward will be one quarter (25%) of any recovery resulting from a copyright infringement (less legal fees and other expenses related to the recovery) up to a maximum reward payment of $25,000. The payment will be made to the individual or individuals who in the opinion of our legal counsel first provided the factual information, which was necessary for the recovery. If you have knowledge regarding the unau-thorized Congress content sharing, contact the Congress registration office.

REGISTRATION BINDING AGREEMENTRegistration (whether online or by this form) constitutes a contract and all of these terms and conditions are binding on the parties. In particular, these terms and conditions shall apply in the case of any credit card dispute.

GENERAL TERMS AND CONDITIONSProgram subject to cancellation or change. If the program is cancelled the only liability of the Congress will be to refund the registration fee paid. The Congress shall have no liability regarding travel or other costs. Registration form submitted via fax, mail, email or online constitutes binding agreement between the parties.

FOR FURTHER INFORMATIONCall 1-800-503-8171 (Continental US, Alaska and Hawaii only) or 1-206-452-5528, send e-mail to registration@hcconferences.com, or visit our website at www.InternationalPharmaCongress.com.

THE FOLLOWING REGISTRATION TERMS AND CONDITIONS APPLY

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FOURTEENTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS CONTINUING EDUCATION CREDITS

NASBA

Health Care Conference Administrators, LLC (dba GHC, LLC Healthcare) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the Na-tional Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit.

Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.learningmarket. org. A recommended maximum of 19 credits based on a 50-minute hour will be granted for the entire learning activity.

This program addresses topics that are of a current concern in the health-care quality and patient safety environment. This is an update, group-live activity. For more information regarding administrative policies such as complaints or refunds, call 206-757-8053 or email petergrant@ehcca.com.

PENDING CONTINUING EDUCATION CREDITS

Attorneys: Pending approval for Pennsylvania CLE Credits.

Compliance Professionals: Pending Compliance Certification Board (CCB) approval of CEUs.

CERTIFICATE OF ATTENDANCE: Onsite attendees can request a Certificate of Attendance which they can file with appropriate entities for credit, and webcast attendees can request an Online Certificate of Attendance on which they can certify the number of hours they watched and can file with appropriate entities for credit.

VISA INFORMATIONTravelers to Germany from the United States, Canada and most European countries do not require a Visa. For specific information regarding your country of origin visit the German Consulate Website in your country of origin.

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HOW TO REGISTER: Fully complete the form below (one form per registrant, photocopies acceptable). Payment must accompany each registration (Euros, payable to Health Care Conference Administrators, LLC).

ONLINE: Secure online registration at www.InternationalPharmaCongress.com.

FAX: +1 206-319-5303 (include credit card information with registration)

MAIL: Conference Office, 12320 NE 8th Street, Suite 201, Bellevue, WA 98005, USA

FOR REGISTRATION QUESTIONS:

PHONE: 1 800-503-8171 (Continental US, Alaska and Hawaii only) or +1-206-452-5528, Monday-Friday, 7 AM - 5 PM PST

E-MAIL: registration@hcconferences.com

CONTACT INFORMATION – INTERNATIONAL CALL CENTER:LONDON, UK — The International Pharma Congress has engaged the UK firm of Bamboo Events Ltd. as agent to handle telephone and email enquiries.

Hours: 9:00 – 17:00 (UK time)

Phone: +44 (0) 208 224 3269

Email: IPCcallcenter@hcconferences.com

INTERNATIONAL PHARMA CONGRESS

COMPLETE THE FOLLOWING. PLEASE PRINT CLEARLY:

NAME

SIGNATURE OF REGISTRANT - REQUIRED

JOB TITLE

ORGANIZATION

ADDRESS

CITY/STATE or PROVINCE/POSTAL CODE

COUNTRY

TELEPHONE

E-MAIL

❏ Special Needs (Dietary or Physical)

ONSITE CONFERENCE ATTENDANCEOnsite conference registration includes onsite attendance of either preconference sessions and the conference, professional networking, and live interaction with the faculty.

PRECONFERENCE (April 20 — Optional; Choose only one.):

❏ I: CHIEF COMPLIANCE OFFICER ROUNDTABLE No-cost, Closed-Door, Invitation-Only

❏ II: A WORKSHOP ON PRACTICAL CASE STUDIES AND EXERCISES IN ETHICS AND COMPLIANCE € 495

CONFERENCE – Standard Individual Rate: ❏ Through Friday, February 21, 2020* €1,795 ❏ Through Friday, March 20, 2020** €1,995 ❏ After Friday, March 20, 2020 €2,195

CONFERENCE – Standard Group Rate:Group registrations submitted from the same organization at the same time receive the following discounted rate for conference registration:❏ Five or more (per person): €1,495 ❏ Ten or more (per person): €1,395

ETHICS/PCF/IFPMA/EFPIA/SFEE/MEDTECH EUROPE/BVMed/FSA/ ITALIAN NETWORK OF COMPLIANCE OFFICERS MEMBER RATE***: ❏ Through Friday, February 21, 2020* €1,395 ❏ Through Friday, March 20, 2020** €1,595 ❏ After Friday, March 20, 2020 €1,795

ETHICS/PCF/IFPMA/EFPIA/SFEE/MEDTECH EUROPE/BVMed/FSA/ITALIAN NETWORK OF COMPLIANCE OFFICERS MEMBER GROUP REGISTRATION***:Group registrations submitted from the same organization at the same time receive the following discounted rate for conference registration:❏ Five or more (per person): €1,295 ❏ Ten or more (per person): €1,195

REGISTRATION BINDING AGREEMENTRegistration (whether online or by this form) constitutes a contract and all of these terms and conditions are binding on the parties. In particular, these terms and conditions shall apply in the case of any credit/debit card dispute. For Webcast and onsite registrants there will be no refunds for “no-shows” or cancellations.

ACCOUNT #

EXPIRATION DATE SECURITY CODE

NAME OF CARDHOLDER

SIGNATURE OF CARDHOLDER

PAYMENT Discount Code:The use of a registration discount code cannot be the basis of requesting a partial refund of fees already paid.

TOTAL FOR ALL OPTIONS:Please enclose payment with your registration and return it to the Registrar at International Pharma Congress, 12320 NE 8th Street, Suite 201, Bellevue, WA 98005, USA, or fax your credit card payment to 1-206-319-5303.

You may also register online at www.InternationalPharmaCongress.com.

❏ Bank transfer (bank information provided upon receipt of form)

❏ Payment by credit card: ❏ American Express ❏ Visa ❏ MastercardIf a credit card number is being given to hold registration only until such time as a bank transfer is received it must be so noted. If payment is not received by seven days prior to the Congress, the credit card payment will be processed. Credit card charges will be listed on your statement as payment to HealthCare (HC) Conf LLC.

* This price reflects a discount for registration & payment received by February 21, 2020.

** This price reflects a discount for registration & payment received by March 20, 2020.

*** To qualify for the ETHICS/PCF/IFPMA/EFPIA/SFEE/MEDTECH EUROPE/BVMed/FSA/ITALIAN NETWORK OF COMPLIANCE OFFICERS member rate an individual must be an individual member or an employee of a member company of the International Society of Healthcare Ethics and Compliance Professionals (ethics), the Pharmaceutical Compliance Forum (PCF), the International Federation of Pharmaceutical Manufactur-ers & Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), MedTech Europe, The German Medical Technology Association (BVMed), Association of Voluntary Self-Regulation for the Pharmaceutical Industry (FSA) and the Italian Network of Compliance Officers.

APPLICABLE VAT FOR ONSITE ATTENDANCE:Upon registering to attend the Congress, you will be charged an additional 19% VAT tax. Upon receipt by the Congress of its German VAT number, you will be emailed a final invoice.

SELECT YOUR MINI-SUMMITS (One from each group):

Tues., April 21ROUND I – 11:00 am❏ I: Compliance Considerations for Small to Mid-Sized Organizations

❏ II: Annual Medical Device Compliance Roundtable

❏ III: Interconnectivity of Auditing, Monitoring, and Investigations

❏ IV: Annual Central and Eastern Europe (CEE) Compliance Best Practices Update

❏ V: Best Practices for Compliance Training

ROUND II – 1:00 pm❏ VI: How to Build and Man- age Healthcare Compliance Risk Assessments❏ VII: How to Effectively Handle Ethics and Compli- ance When Interacting with Third Parties

❏ VIII: Technology and AI to Prevent and Detect Corruption and Kickbacks

❏ IX: Challenges and/or Considerations When Performing FMV Analysis

❏ X: Compliance Consider- ations for Gene Therapy and Ultra Rare Disease Products

ROUND III – 2:15 pm❏ XI: GDPR and the Tumultuous World of Data Privacy❏ XII: Ethics and Compliance Issues in Patient Relation- ships, Including Patient Access and Support

❏ XIII: Enhanced Compliance Monitoring

❏ XIV: Building Effective and Right Sized Compliance Programs . . .

❏ XV: The Role of Compli- ance Officers in Complex Global Organizations

Wed., April 22ROUND IV – 8:30 am❏ XVI: Annual Middle East Africa (MEA) Compliance Update❏ XVII: The Role of the Industry re: Medical Education —Trends and Aspects

❏ XVIII: EU Whistleblower Directive

SPECIAL SUBSCRIPTION OFFER FOR ATTENDEES:You can purchase an annual subscription to Life Science Compliance Update, www.lifescicom-pliance.com, for only €1,020 (a 15% discount off of the regular subscription rate). Life Science Compliance Update is a monthly publication providing comprehensive, up-to-date compli-ance information for pharmaceutical, biotechnology and device manufacturers. Each issue covers important news and analysis, with input from top compliance officers and healthcare attorneys across the industry. The LSC Update offers practical insights into: False Claims Act, Qui Tam developments, FCPA, healthcare fraud alerts and enforcement trends, the Physician Payment Sunshine Act, EFPIA Transparency, Medicines Australia Transparency, FDA and EMA guidance and warnings, international regulations, and best practices for compliance.❏ Annual subscription to Life Science Compliance Update: €1,020