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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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".

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.

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.

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.

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 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".

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.

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.

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 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.

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.

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

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

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.

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 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.

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.