international pharmaceutical compliance congress
international pharmaceutical compliance congress
international pharmaceutical compliance congress
international pharmaceutical compliance congress
international pharmaceutical compliance congress
international pharmaceutical compliance congress



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Agenda: International Pharma Congress: EFPIA Codes Training Workshop (Registration Complimentary)
Tuesday, May 10, 2016


Sponsored by the European Federation of Pharmaceutical Industries and Associations (EFPIA)
EFPIA CODES TRAINING WORKSHOP
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is offering an independent EFPIA CODES TRAINING WORKSHOP on Tuesday, May 10, 2016 from 10:00 am to 12:45 pm, including a luncheon.

What can we learn from each other?
  • Come and work through practical cases to help improve your understanding of the Codes and global requirements as well as their implementation by national associations.
  • Each section will include presentation of a realistic case scenario with a description of the relevant requirements from the national, EFPIA, and/or IFPMA codes.
10:00 a.m.

Faculty

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

    Speaker Bio

    Julie Bonhomme joined the European Federation of Pharmaceutical Industries and Associations in December 2014, as Legal Affairs & Compliance Deputy Director.

    Before joining the EFPIA, Julie worked as Legal and Compliance Manager at Leem (the French Association for Pharmaceutical Companies in France), where she gained more than 7 years experience. Prior to her experience with the industry, Julie was a member of the Paris Bar, working for a major international law firm in Paris, France.

    She specializes in pharmaceutical law (regulatory issues) and compliance issues such as the implementation of the EFPIA Disclosure Code, and the relationships between pharmaceutical companies and their stakeholders.
Marie-Claire Pickaert
Deputy Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium

    Speaker Bio

    Current Professional Position
    Ms Pickaert is the Deputy Director General of EFPIA, member of EFPIA's General Management.

    Since 2008, Ms Pickaert is coordinating EFPIA's ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.

    In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA's relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.

    Education
    Master in Economic Science from the Vrije Universiteit te Brussel (Belgium) ? with honours

    Thesis: Economic and Social Impact of Education and the Value of Human Capital ? first class honours

    Continued education and specialisation ? postgraduate / executive training

    * Applied Psychology in Economics (2 years)

    * Auditing and Valuation of Enterprises (2 years)

    * Hospital Management (1 year)
    Presentation Material (Acrobat)
Heather Simmonds
Director, Prescription Medicines Code of Practice Authority, London, UK

    Speaker Bio

    Heather Simmonds is the Director of the Prescription Medicines Code of Practice Authority (PMCPA). Heather chairs the Code of Practice Panel, which considers complaints submitted under the Code in the first instance, and is responsible for the overall running of the organisation. Heather also works with IFPMA and EFPIA in relation to their codes of practice.

    Heather has a degree in pharmacology and joined the ABPI in 1984. Heather has been working full time on the Code of Practice since 1989 and has been Director of the Authority since 1997.
12:45 p.m. Adjournment

Agenda: International Pharma Congress: Day I
Tuesday, May 10, 2016

DAY I OPENING PLENARY SESSION
12:45 p.m.

Welcome from INFARMA

Pawel Sztwiertnia
Chief Executive Officer, Employers' Union of Innovative Pharmaceutical Companies (INFARMA); Former Undersecretary of State, Polish Ministry of Health, Warsaw, Poland
12:50 p.m.

The Gabor Danielfy Memorial Keynote Overview and International Pharma Congress Welcome

Ann Beasley
Chief Compliance Officer, Biogen; Former Global Compliance Officer, Novartis Pharma AG; Board Member and Co-chair, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Cambridge, MA, USA (Co-chair)

    Speaker Bio

    Ms. Beasley is Senior Vice President and Chief Compliance Officer at Biogen. In her role, Ms. Beasley is responsible for developing, coordinating and implementing the Biogen Corporate Compliance Program. Prior to working with Biogen, Ms. Beasley led the global compliance functions for Novartis Pharma AG and Novartis Vaccines and Diagnostics. She also held legal and compliance positions with other large and mid-sized pharmaceutical and biotechnology companies, including Sepracor Inc. (now Sunovion), Boehringer Ingelheim Pharmaceuticals, Inc. and Genzyme Corporation. In the course of her practice, Ms. Beasley has provided fraud and abuse/anti-bribery legal analysis, reviewed and developed policies for interactions with healthcare professionals, implemented Compliance Program procedures; developed Codes of Conduct, and advised on U.S. and European Union privacy issues. She has lectured to a variety of groups on healthcare compliance and privacy issues as they impact bio/pharmaceutical and device companies. As well, Ms. Beasley trains various employee groups on selected life sciences compliance topics. Ms. Beasley received her B.A. from the University of Tulsa and her Juris Doctorate from Northeastern University School of Law. Ms. Beasley is admitted to the Massachusetts and U.S. Supreme Court Bar. She is a board member of ETHICS, a professional society for compliance officers operating in the healthcare industry.
Michael Bartke, PhD
Director, Compliance Management, DAIICHI SANKYO EUROPE GmbH, Munich, Germany (Co-chair)

    Speaker Bio

    CURRENT POSITION
    Since 2008 Daiichi Sankyo Europe GmbH (European HQ), Director Compliance Management & Compliance Officer
    EFPIA member & vice chair of EFPIA Compliance Committee
    IFPMA member of CCN Code Compliance Network

    WORK EXPERIENCE
    joined Daiichi Sankyo 2001 as Head of Marketing Germany Daiichi Sankyo Europe GmbH 2006 (European HQ) as Director Strategic Marketing Cardiovascular for Europe
    • Experience 30 years within pharmaceutical industry - research based companies ICI (Astra Zeneca) and Bristol Myers Squibb
    • Worked in various functions and national/international projects in marketing, strategic planning, business development
    • Build up compliance organisation and program from scratch

    EDUCATION
    PhD and Diploma in organic chemistry
Dominique Laymand, Esq.
Senior Vice President, Chief Ethics and Compliance Officer, Ipsen; President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)

    Speaker Bio

    Dominique Laymand is President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to developing and enhancing the highest professional standards in the Healthcare Sector, contributing to the development of professionals and the success of Ethics and Compliance organizations.

    Dominique Laymand is Senior vice-president, Chief Ethics and Compliance Officer at Ipsen. Dominique is also member of the Chairman's Committee. Dominique will be further developing the Ipsen Ethics & Compliance Program and Organization.
Stephen Nguyen-Duc
Area Director Ethics and Compliance Western Europe-Israel and Canada, AbbVie; Former Director, Ethics and Compliance Officer, Eli Lilly and Company, Paris, France (Co-chair)

    Speaker Bio

    Stephen is currently Director for Ethics & Compliance Operations in Western Europe, Canada & Israel for Abbvie Pharmaceuticals.

    He also covered for a period of time Ethics & Compliance operations for Eastern Europe, Middle East & Africa.

    Prior to joining Abbvie, he was Ethics & Compliance Director at Eli Lilly in France.

    He also previously held multiple roles in Human Resources, Sales training, Six Sigma and Clinical research in different companies including Bayer and Glaxo SmithKline in France, Belgium and Turkey.

    Stephen is currently member of the Compliance Steering Group of EFPIA and Steering member of Ethics (international Society of Healthcare Ethics & Compliance professionals).

    Stephen is graduated from the Pharmacy School of Paris with a major in industrial pharmacy and pharmacology and from the YMP of INSEAD Business School.
Roeland Van Aelst
Regional Vice President, HCCO MD&D EMEA and Canada, Office of Health Care Compliance and Privacy, Johnson & Johnson; Co-chair, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS); Chairman, MedTech Compliance Network, Brussels, Belgium (Co-chair)
1:00 p.m.

Transparency International Keynote

Sophie Peresson, LLM, MA
Global Health Policy Director, Pharmaceuticals and Healthcare, Transparency International; Former Regional Director, International Diabetes Federation European Region; Former Senior Policy Advisor, Standing Committee of European Doctors, London, UK

Presentation Material (Acrobat)
Introduction by Ann Beasley
Chief Compliance Officer, Biogen; Former Global Compliance Officer, Novartis Pharma AG; Board Member and Co-chair, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Cambridge, MA, USA (Co-chair)

    Speaker Bio

    Ms. Beasley is Senior Vice President and Chief Compliance Officer at Biogen. In her role, Ms. Beasley is responsible for developing, coordinating and implementing the Biogen Corporate Compliance Program. Prior to working with Biogen, Ms. Beasley led the global compliance functions for Novartis Pharma AG and Novartis Vaccines and Diagnostics. She also held legal and compliance positions with other large and mid-sized pharmaceutical and biotechnology companies, including Sepracor Inc. (now Sunovion), Boehringer Ingelheim Pharmaceuticals, Inc. and Genzyme Corporation. In the course of her practice, Ms. Beasley has provided fraud and abuse/anti-bribery legal analysis, reviewed and developed policies for interactions with healthcare professionals, implemented Compliance Program procedures; developed Codes of Conduct, and advised on U.S. and European Union privacy issues. She has lectured to a variety of groups on healthcare compliance and privacy issues as they impact bio/pharmaceutical and device companies. As well, Ms. Beasley trains various employee groups on selected life sciences compliance topics. Ms. Beasley received her B.A. from the University of Tulsa and her Juris Doctorate from Northeastern University School of Law. Ms. Beasley is admitted to the Massachusetts and U.S. Supreme Court Bar. She is a board member of ETHICS, a professional society for compliance officers operating in the healthcare industry.
1:30 p.m.

Overview of the Anti-Corruption Landscape

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

    Speaker Bio

    Dr. Peter Dieners is a Partner of Clifford Chance based in Dusseldorf, Germany. He is the Regional Managing Partner for Germany and heads the Global Healthcare, Life Sciences and Chemicals industry group of Clifford Chance, Dr. Peter Dieners is specialized in healthcare related regulations, healthcare fraud and abuse prevention, compliance and healthcare-related commercial and corporate transactions. He advises leading pharmaceutical, medical device and chemical companies on all of their business-critical corporate, commercial and compliance matters including investigations and related prevention counselling. He acts for trade associations and companies vis-a-vis government agencies in relation to legislative projects and amendments as wen as for the elaboration of compliance related industry codes of conduct.
    Presentation Material (Acrobat)
2:00 p.m.

The National Anti-Corruption Strategy of Romania

Adrian Baboi-Stroe, MA, MPP
Secretary of State, Ministry of Justice, Author, "Corruption and Anti-corruption Policy in Romania" in Monitoring EU Accession Process: Corruption and Anti-Corruption Policy, Bucharest, Romania

    Speaker Bio

    I am a public policy expert with an extensive work experience with leading Romanian civil society organizations, where I was in charge with the coordination and implementation of projects in areas as varied as policy research, advocacy for policy change, public campaigning and civic education.

    My professional experience also includes work in the European Parliament, where I dealt with anti-corruption and anti-fraud policies at the EU level, access to documents and budgetary control of EU agencies, and modernisation of public procurement.

    My professional path brought me in direct contact with the monitoring and evaluation of EU-funded projects, which allowed me to attain a hands-on experience of project management.

    My career displays commitment to the pursuit of policy-relevant research and a steady engagement with good governance, anticorruption policy and institutional transparency.
    Presentation Material (Acrobat)
Introduction by Mariusz Witalis
Partner, Fraud Investigation and Dispute Services, EY, Warsaw, Poland

    Speaker Bio

    Mariusz Witalis is a Partner leading the EY Fraud Investigation & Dispute Services (FIDS) practice in Poland and the Baltic countries. He specializes in assisting pharmaceutical manufactures, medical device companies and biotechnology companies with internal and government investigations and in compliance-related matters. He is coordinating EY FIDS life sciences activities across Europe, Middle East, India & Africa.

    He has vast experience working with legal counsels, internal audit and compliance functions on the matters arising under the US Foreign Corrupt Practices Act as well as a number of other country-specific anti-corruption and competition regulations. He has been advising a number of pharmaceutical, medical device, and biotechnology companies on compliance-related topics in over 40 EMEIA countries.

    Mr. Witalis is a frequent speaker at international conferences and seminars devoted to compliance and fraud management and an author of numerous articles on compliance and business fraud. He has a Diploma of Polish Statutory Auditor, Certified Internal Auditor and is a Certified Fraud Examiner.
2:30 p.m.

US Department of Justice Healthcare Compliance Update

Laura Cordova, Esq.
Assistant Chief, Houston and Dallas Strike Force, Corporate Matters, US Department of Justice, Washington, DC

    Speaker Bio

    Laura Cordova is an Assistant Chief in the Department of Justice Criminal Division's Fraud Section. Laura oversees the Fraud Section's Corporate Health Care Fraud Strike Force based in Washington, DC. The Corporate Health Care Fraud Strike Force has a nation-wide focus and prosecutes health care fraud and related crimes committed by companies involved in various aspects of the health care system. As a member of the Fraud Section for more than five years, Laura has prosecuted a variety of health care fraud cases and supervised the Medicare Fraud Strike Force operations in numerous cities. Prior to joining the Department of Justice, Laura spent several years in private practice at international law firms.
James McDonald, Esq.
Trial Attorney, Criminal Division, Fraud Section, US Department of Justice, Washington, DC

Presentation Material (Acrobat)
Gary Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, and Head, Government Investigations, Pfizer Inc. (Moderator)

    Speaker Bio

    Gary Giampetruzzi is a partner in the Investigations and White Collar practice in the Litigation Department of Paul Hastings, based in the firm's New York office. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, and represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), the Foreign Corrupt Practices Act ("FCPA"), and oversees other complex civil and criminal litigation matters. While his practice cuts across numerous sectors, Mr. Giampetruzzi possesses particularly deep experience in the life sciences sector, representing many of the world's most prominent biotech, pharmaceutical, and medical device companies.

    Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc, with responsibility for government investigations across the company's multiple business units and operations globally, and Deputy Compliance Officer responsible for international compliance investigations and programs. He is highly regarded by counsel, healthcare industry insiders, and regulators for his strategic thinking and sound judgment, and brings unique experience and perspective to each representation, having himself been the client for more than a decade.
3:15 p.m.

Anti-Corruption Roundtable: Strategies to Foster Compliance

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

    Speaker Bio

    Dr. Peter Dieners is a Partner of Clifford Chance based in Dusseldorf, Germany. He is the Regional Managing Partner for Germany and heads the Global Healthcare, Life Sciences and Chemicals industry group of Clifford Chance, Dr. Peter Dieners is specialized in healthcare related regulations, healthcare fraud and abuse prevention, compliance and healthcare-related commercial and corporate transactions. He advises leading pharmaceutical, medical device and chemical companies on all of their business-critical corporate, commercial and compliance matters including investigations and related prevention counselling. He acts for trade associations and companies vis-a-vis government agencies in relation to legislative projects and amendments as wen as for the elaboration of compliance related industry codes of conduct.
Cristian Ducu, PhD
General Manager, Centre for Advanced Research in Management and Applied Ethics; Founding Member, European Ethics & Compliance Association, University of Bucharest, Bucharest, Romania

    Speaker Bio

    Cristian holds a PhD in Moral Philosophy from the University of Bucharest, magna cum laude. He is the General Manager of the Centre for Advanced Research in Management and Applied Ethics, an independent research and consulting NGO. He is also the President of the Supervising Commission for the Lobbying and Advocacy Transparency Registry, an independent tool developed by the Romanian Lobbying Registry Association, and, from 2010 until 2013, he served as member of the National Committee for Bioethics, UNESCO-National Comission of Romania.
Michael K. Loucks, Esq.
Partner, Skadden Arps LLP; Former Acting United States Attorney, US Attorney's Office for the District of Massachusetts, Washington, DC, USA

    Speaker Bio

    Michael K. Loucks is an experienced trial and appellate attorney whose practice focuses on internal investigations and government enforcement matters in the United States and abroad, and on false claims act litigation in federal and state courts. Prior to joining Skadden in 2010, Mr. Loucks had most recently served as acting U.S. attorney and first assistant U.S. attorney for the District of Massachusetts.

    Since joining Skadden in 2010, Mr. Loucks' practice has focused on representing companies in government criminal investigations, in False Claims Act and other civil litigation, in regulatory matters with the Food and Drug Administration and the Office of Inspector General, and in Foreign Corrupt Practices Act investigations.

    He was a nationally recognized health care fraud prosecutor, handling many of the department's most high-profile health care fraud prosecutions of the past two decades. He joined the U.S. Attorney's Office in 1985, after five years in private practice.
Paul J. Melling, Esq.
Founding Partner, Baker & McKenzie - CIS, Limited, Moscow, Russia

    Speaker Bio

    Paul Melling is an English solicitor and the founding partner of Baker & McKenzie's Moscow office. He has spent over 25 years as a lawyer living and working in Moscow. He leads his firm's pharmaceuticals and healthcare industry practice in Russia/CIS and, since 1994, has been the Honorary Legal Adviser to the Association of International Pharmaceuticals Manufacturers (AIPM). Mr. Melling also leads his firm's compliance practice in Russia/CIS and is a Steering Committee member of both his Firm's EMEA Pharmaceuticals & Healthcare Practice Group and its EMEA Compliance Practice Group.

    In 2009 Mr. Melling received AIPM's Distinguished Service Award for "Outstanding Contribution to the Development of the Russian Pharmaceuticals Market".
Vivian Robinson, Esq.
Queen's Counsel, Partner, McGuire Woods; Former General Counsel of the UK Serious Fraud Office; Former Head, QEB Hollis Whiteman Chambers; Recorder of the Crown Court and Treasurer of Inner Temple, London, UK
Ted Acosta, Esq.
Americas Vice Chair, Risk Management, EY; Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services, New York, NY, USA and Paris, France (Moderator)

    Speaker Bio

    Ted Acosta is the EY Americas Vice Chair, Risk Management and a member of the EY Americas Operating Executive. Ted is also the Global Leader of EY's Life Sciences Fraud Investigation & Dispute Services team.

    He has extensive experience helping clients address risk issues across the enterprise, building infrastructures and designing prevention and change management programs. A lawyer by background, he has worked in the field with our teams in more than 50 countries assisting companies with risk matters, thereby gaining an understanding of the judicial and regulatory systems throughout the world.

    Prior to joining EY, Ted was a Senior Counsel in the Inspector General's Office for the US Department of Health and Human Services, where he worked prosecutions, investigations and audits.
4:15 p.m. Break
MINI SUMMITS - ROUND I
MINI SUMMIT I: ANTI-CORRUPTION CASE STUDY: EXAMINING A HYPOTHETICAL INVESTIGATION FROM ALL SIDES
4:45 p.m. Introductions, Panel Discussion and Q&A
Alessandra Hawthorne, Esq.
Global Chief Ethics and Compliance Officer, Boehringer Ingelheim, Ingelheim, Germany

    Speaker Bio

    Ali leads BI's global Ethics and Compliance program, designed to ensure that BI's business practices are conducted in compliance with all applicable laws and Company policies,,and are consistent with its high ethical standards. Ali joined BI in 2005, serving most recently as the Chief Compliance Officer for BI's US entity. Ali received her law degree from Tulane Law School (1997) and her undergraduate degree from Smith College (1994). She currently resides in the Frankfurt, Germany area with her husband and two children.
Vivian Robinson, Esq.
Queen's Counsel, Partner, McGuire Woods; Former General Counsel of the UK Serious Fraud Office; Former Head, QEB Hollis Whiteman Chambers; Recorder of the Crown Court and Treasurer of Inner Temple, London, UK
Daniel Schafaghi
Corporate Ethics and Compliance, Boehringer Ingelheim GmbH, Ingelheim, Germany
Gary Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, and Head, Government Investigations, Pfizer Inc., Washington, DC, USA (Moderator)

    Speaker Bio

    Gary Giampetruzzi is a partner in the Investigations and White Collar practice in the Litigation Department of Paul Hastings, based in the firm's New York office. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, and represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), the Foreign Corrupt Practices Act ("FCPA"), and oversees other complex civil and criminal litigation matters. While his practice cuts across numerous sectors, Mr. Giampetruzzi possesses particularly deep experience in the life sciences sector, representing many of the world's most prominent biotech, pharmaceutical, and medical device companies.

    Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc, with responsibility for government investigations across the company's multiple business units and operations globally, and Deputy Compliance Officer responsible for international compliance investigations and programs. He is highly regarded by counsel, healthcare industry insiders, and regulators for his strategic thinking and sound judgment, and brings unique experience and perspective to each representation, having himself been the client for more than a decade.
    Presentation Material (Acrobat)

    Polling Question Report (Acrobat)
6:00 p.m. Adjournment and Networking Reception

MINI SUMMIT II: ANNUAL CEE COMPLIANCE UPDATE
4:45 p.m. Introductions, Panel Discussion and Q&A

Cristian Ducu, PhD
General Manager, Centre for Advanced Research in Management and Applied Ethics; Founding Member, European Ethics & Compliance Association, University of Bucharest, Bucharest, Romania

    Speaker Bio

    Cristian holds a PhD in Moral Philosophy from the University of Bucharest, magna cum laude. He is the General Manager of the Centre for Advanced Research in Management and Applied Ethics, an independent research and consulting NGO. He is also the President of the Supervising Commission for the Lobbying and Advocacy Transparency Registry, an independent tool developed by the Romanian Lobbying Registry Association, and, from 2010 until 2013, he served as member of the National Committee for Bioethics, UNESCO-National Comission of Romania.
Paul J. Melling, Esq.
Founding Partner, Baker & McKenzie-CIS, Limited, Moscow, Russia

    Speaker Bio

    Paul Melling is an English solicitor and the founding partner of Baker & McKenzie's Moscow office. He has spent over 25 years as a lawyer living and working in Moscow. He leads his firm's pharmaceuticals and healthcare industry practice in Russia/CIS and, since 1994, has been the Honorary Legal Adviser to the Association of International Pharmaceuticals Manufacturers (AIPM). Mr. Melling also leads his firm's compliance practice in Russia/CIS and is a Steering Committee member of both his Firm's EMEA Pharmaceuticals & Healthcare Practice Group and its EMEA Compliance Practice Group.

    In 2009 Mr. Melling received AIPM's Distinguished Service Award for "Outstanding Contribution to the Development of the Russian Pharmaceuticals Market".
Katalin Pungor, MD, PhD, MBA
Director, Healthcare Compliance, Emerging Markets and CEE, Johnson & Johnson, Budapest, Hungary
Mariusz Witalis
Partner, Fraud Investigation and Dispute Services, EY, Warsaw, Poland (Moderator)

    Speaker Bio

    Mariusz Witalis is a Partner leading the EY Fraud Investigation & Dispute Services (FIDS) practice in Poland and the Baltic countries. He specializes in assisting pharmaceutical manufactures, medical device companies and biotechnology companies with internal and government investigations and in compliance-related matters. He is coordinating EY FIDS life sciences activities across Europe, Middle East, India & Africa.

    He has vast experience working with legal counsels, internal audit and compliance functions on the matters arising under the US Foreign Corrupt Practices Act as well as a number of other country-specific anti-corruption and competition regulations. He has been advising a number of pharmaceutical, medical device, and biotechnology companies on compliance-related topics in over 40 EMEIA countries.

    Mr. Witalis is a frequent speaker at international conferences and seminars devoted to compliance and fraud management and an author of numerous articles on compliance and business fraud. He has a Diploma of Polish Statutory Auditor, Certified Internal Auditor and is a Certified Fraud Examiner.
6:00 p.m. Adjournment and Networking Reception

MINI SUMMIT III: ETHICS AND COMPLIANCE PROGRAMS OF THE FUTURE: NEW STRATEGIES FOR INTEGRATED ASSESSMENT AND MANAGEMENT OF RISKS
4:45 p.m. Introductions, Discussion and Q&A

Ann Beasley
Chief Compliance Officer, Biogen; Former Global Compliance Officer, Novartis Pharma AG; Board Member and Co-chair, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Cambridge, MA, USA (Co-chair)

    Speaker Bio

    Ms. Beasley is Senior Vice President and Chief Compliance Officer at Biogen. In her role, Ms. Beasley is responsible for developing, coordinating and implementing the Biogen Corporate Compliance Program. Prior to working with Biogen, Ms. Beasley led the global compliance functions for Novartis Pharma AG and Novartis Vaccines and Diagnostics. She also held legal and compliance positions with other large and mid-sized pharmaceutical and biotechnology companies, including Sepracor Inc. (now Sunovion), Boehringer Ingelheim Pharmaceuticals, Inc. and Genzyme Corporation. In the course of her practice, Ms. Beasley has provided fraud and abuse/anti-bribery legal analysis, reviewed and developed policies for interactions with healthcare professionals, implemented Compliance Program procedures; developed Codes of Conduct, and advised on U.S. and European Union privacy issues. She has lectured to a variety of groups on healthcare compliance and privacy issues as they impact bio/pharmaceutical and device companies. As well, Ms. Beasley trains various employee groups on selected life sciences compliance topics. Ms. Beasley received her B.A. from the University of Tulsa and her Juris Doctorate from Northeastern University School of Law. Ms. Beasley is admitted to the Massachusetts and U.S. Supreme Court Bar. She is a board member of ETHICS, a professional society for compliance officers operating in the healthcare industry.
Isaure Kergall-Gayet
Compliance and Business Integrity Director France, Sanofi, Paris, France

    Speaker Bio

    Mrs Kergall-Gayet is Compliance & Business Integrity Director, France for Sanofi. Prior to working with Sanofi, Ms. Kergall-Gayet created and led the global Ethics & Compliance function for Ipsen, as VP, Chief Ethics & Compliance Officer. She also held legal, financial and compliance positions with Eli Lilly where she created the Ethics & Compliance department of the French Affiliate.

    She leads the Compliance Group of the LEEM and is a member of the strategic committee of Ethics.

    Mrs Kergall-Gayet is graduated from the French business school Ecole Supérieure de Commerce de Paris (ESCP) and is a certified attorney (French Bar).
Dominique Laymand, Esq.
Senior Vice President, Chief Ethics and Compliance Officer, Ipsen; President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)

    Speaker Bio

    Dominique Laymand is President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to developing and enhancing the highest professional standards in the Healthcare Sector, contributing to the development of professionals and the success of Ethics and Compliance organizations.

    Dominique Laymand is Senior vice-president, Chief Ethics and Compliance Officer at Ipsen. Dominique is also member of the Chairman's Committee. Dominique will be further developing the Ipsen Ethics & Compliance Program and Organization.
Ariadna Quesada
Compliance Manager Europe, Middle-East, and Africa, MicroPort Orthopedics Inc., Amsterdam, Netherlands
George Fife
Executive Director, Fraud Investigation and Dispute Services, EY; Former Executive Director, Compliance and Ethics, Bristol-Myers Squibb, Paris, France (Moderator)

    Speaker Bio

    George Fife is Executive Director at EY, in the EMEIA Life Sciences Compliance, Fraud Investigation & Dispute Services practice. George specializes in assisting companies with global risk and compliance assessments and investigations. George works closely with management teams, chief compliance officers, general counsels and chief audit executives to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives to prevent, detect and respond to compliance risks.

    George is a compliance and ethics professional with more than 17 years of in-house compliance life science experience. He has first-hand international experience in building, managing and assessing effectiveness of compliance programs, in the area of anti-corruption and anti-bribery (such as US FCPA, UK Bribery Act, Italy d.lgs 231/01,?) amongst others, embedding analytics into monitoring, driving compliance investigations, designing cutting-edge compliance solutions in anticipation of new emerging risk area?s such as Transparency. He assists clients to develop pragmatically their compliance and monitoring programs based on company culture and level of maturity.

    Prior EY, George worked at Bristol-Myers Squibb where he served as the EMEA Executive Director, Compliance & Ethics and globally anti-corruption and third-parties. Prior to BMS, George worked at GE Healthcare in a regional EMEA Compliance and Third-Parties Manager role.
    Presentation Material (Acrobat)
6:00 p.m. Adjournment and Networking Reception

MINI SUMMIT IV: PATIENT PROGRAMS -- MANAGING THE VARIOUS RISKS OF GETTING CLOSER TO THE PATIENT
4:45 p.m. Introductions, Panel Discussion and Q&A

Przemyslaw Bochenski
Medical Director, Abbvie, Warsaw, Poland

    Speaker Bio

    Przemyslaw Bochenski joined AbbVie in 2016, in his current role as a Medical Director. Prior to joining AbbVie, he was a Medical Director for Janssen Poland and than Russia & CIS.

    He also held several positions at Eli Lilly Polska including Medical&Regulatory Director, Regional EU Senior CRP and Clinical Research Physician in Poland.

    By training Przemyslaw is MD, specialists in anesthesia and intensive care, holding as well PhD in anesthesia.
Cécile Gousset
Associate Vice President, Compliance Risk Assessment, Education and Monitoring, Global Ethics and Business Integrity, Sanofi, Paris, France

    Speaker Bio

    Education - Background:
    PharmD

    Experience:
    • 13 years in Sanofi in Regulatory Affairs (French affiliate) and Global Medical Operations (Head of Medical Information Compliance Department).
    • In Global Ethics & Business Integrity department since 2013.
    • Outside Sanofi, 6 years in Astra-Zeneca France (Regulatory Affairs) and 2 years in Merieux UK (Product Manager).
Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC, USA

    Speaker Bio

    Keith Korenchuk is a partner in the FDA and Healthcare practice of Arnold & Porter, LLP in Washington D.C. He counsels and advises pharmaceutical, life sciences, medical device, biotechnology, and specialty pharmacy companies in the United States and worldwide on regulatory and compliance matters, including on the following matters:
    • US and global compliance systems design, implementation, and ongoing assessment
    • Regulatory matters involving healthcare professionals, including fraud and abuse, off-label promotion, False Claims Act and transparency related issues
    • Global anti-bribery legislation, including the US Foreign Corrupt Practices Act, the Organization for Economic Co-operation and Development (OECD) Anti-bribery Convention, and related national implementing legislation
    • Internal and government initiated investigations
    • State legislation involving pharmaceutical and medical device marketing and disclosure
    • Global, regional, and country specific codes of practice and conduct, including codes issues by Pharmaceutical Research and Manufacturers of America (PhRMA), AdvaMed, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), and Eucomed
    • Enterprise-wide risk management systems and programs
    • Pharmaceutical price reporting and third party/managed markets negotiations
Oscar Perdomo
Director, Pharmaceuticals and Life Sciences, PwC, Switzerland

    Speaker Bio

    Professional Experience
    Oscar Perdomo is a Director in PwC's Pharmaceutical and Life Sciences practice with over 10 years of experience in the pharmaceutical and life sciences industry. Throughout his career Oscar has partnered with clients to deliver services related to strategy and business planning, business analytics, risk management, and project management.

    Oscar has worked with many global pharmaceutical and life sciences companies to build and enhance their global compliance programs and to mitigate risks associated with interactions with healthcare professionals, anti-kickback laws, and anti-bribery / anti-corruption laws. In addition, Oscar has worked with clients to audit and monitor business activities, develop corrective action plans, draft and update policies and procedures, and train employees on global compliance issues and standards.

    Education
    Oscar Perdomo received his Masters in Public Health from the University of California, Los Angeles and his Bachelor of Science from Loyola Marymount University.
Stephen Nguyen-Duc
Area Director Ethics and Compliance Western Europe-Israel and Canada, AbbVie; Former Director, Ethics and Compliance Officer, Eli Lilly and Company, Paris, France (Moderator)

    Speaker Bio

    Stephen is currently Director for Ethics & Compliance Operations in Western Europe, Canada & Israel for Abbvie Pharmaceuticals.

    He also covered for a period of time Ethics & Compliance operations for Eastern Europe, Middle East & Africa.

    Prior to joining Abbvie, he was Ethics & Compliance Director at Eli Lilly in France.

    He also previously held multiple roles in Human Resources, Sales training, Six Sigma and Clinical research in different companies including Bayer and Glaxo SmithKline in France, Belgium and Turkey.

    Stephen is currently member of the Compliance Steering Group of EFPIA and Steering member of Ethics (international Society of Healthcare Ethics & Compliance professionals).

    Stephen is graduated from the Pharmacy School of Paris with a major in industrial pharmacy and pharmacology and from the YMP of INSEAD Business School.
    Presentation Material (Acrobat)
6:00 p.m. Adjournment and Networking Reception

MINI SUMMIT V: ANNUAL MEA COMPLIANCE UPDATE
4:45 p.m. Introductions, Discussion and Q&A

Rifat Bozacioglu
Deputy Compliance Officer, ME Pharma, GSK, Istanbul, Turkey

    Speaker Bio

    Rifat Bozacioglu is a Director with GSK and has over 15 years of experience in audit, compliance and risk management practices in Turkey and Germany. He is a member of Ethics and Compliance Initiative, and currently leads the compliance organisation for GSK Pharmaceuticals covering Middle East markets. Rifat has significant risk management, anti-corruption investigation and compliance experience. He is certified as Leading Professional in Ethics & Compliance (LPEC).
Abdallah El Saadi, CCP
Regional Compliance Officer - Middle East, Turkey and Africa, Boehringer Ingelheim, Former Cluster Compliance Lead, Gulf states & Saudi Arabia, Merck, Former Country Ethics & Compliance Manager (Saudi Arabia), Eli Lilly and Company, Dubai, UAE

    Speaker Bio

    Abdallah is the Regional Compliance Officer for Middle East, Africa & Turkey region for Boehringer Ingelheim. He has been working with various multinational in Ethics & Compliance roles in the Middle East for the last 6 years.

    Abdallah is a qualified Pharmacist who has over 12 year's experience in the pharmaceutical industry split between sales roles and E&C roles.
Elvan Sevi Firat
Founding Partner, Firat - Izgi Attorney Partnership; Board Member, Transparency International Turkey Section, Istanbul, Turkey

    Speaker Bio

    Mrs. Firat regularly supports multinational companies including manufacturers of pharmaceuticals, biotechnology, medical devices, special food and feed, cosmetics and other consumer products on important new legislative projects and policy developments in Turkey. She also advises and provides consultancy on strategic planning of new investments and start-ups in Turkey, regulatory compliance, anti-corruption and anti-trust. She also has broad litigation experience of life science matters, including product liability, advertising, customs controls and promotional activities.

    Mrs. Firat has in depth involvement in the first ever initiated court actions in Turkey in order to protect patent rights, including administrative court actions, as well as regulatory works before the Ministry of Health regarding enforcement of pharmaceutical patent rights, data protection and data exclusivity.

    In addition to her experience in regulatory and compliance matters, Mrs.Firat also regularly represents clients before the Turkish civil, criminal and administrative courts.
Minal Patel
Compliance Officer, Pharmaceuticals & Consumer, South Africa & Sub Saharan Africa, Johnson & Johnson, Johannesburg, South Africa
Laura Nassar
Head of Compliance, Middle East, Hoffmann-La Roche Ltd., Dubai, UAE (Moderator)

    Speaker Bio

    Laura Nassar is the Head of Compliance for Middle East at Hoffmann La Roche, based in Dubai. Since Feb 2016, she is appointed Chair of PhRMAG (PhRMA Gulf) Compliance and Legal Working Group.

    Laura is a long-standing member of the Middle East Ethics Review Board (LERB), governing body of the MEA Code of Promotional Practices.

    She has over 17 years' experience in the healthcare industry, across a wide range of disciplines such as Pharmacy, Sales and Marketing, Skills Training and Compliance.

    She worked closely with management teams in Turkey, Middle East, West Asia and Africa to build a strong compliance structure and support sustainable business growth.

    Laura holds a Pharm.D degree from St Joseph University in Beirut, Lebanon.
6:00 p.m. Adjournment and Networking Reception



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