Agenda Links: Precon/Day 1 | Day 3
AGENDA: DAY II
TUESDAY, SEPTEMBER 11, 2018
7:00 am
Registration Opens: Continental Breakfast in Exhibit Hall
DAY II MORNING PLENARY SESSION
8:30 am
Co-chair Welcome and Introductions
8:45 am
GDPR Privacy Compliance Update
Giovanni Buttarelli
European Data Protection Supervisor; Former Secretary General, Italian Data Protection Authority, Brussels, Belgium
European Data Protection Supervisor; Former Secretary General, Italian Data Protection Authority, Brussels, Belgium
Mr. Giovanni Buttarelli was appointed European Data Protection Supervisor in December 2014 by a joint decision of the European Parliament and the Council for a term of five years.
Before joining the EDPS, he worked as Secretary General to the Italian Data Protection Authority, a position he occupied from 1997 to 2009. A member of the Italian judiciary with the rank of Cassation judge, he has attended to many initiatives and committees on data protection and related issues at international level.
The experience on data protection includes the participation in many bodies at European Union level (including Art. 31 Committee of Directive n. 95/46/EC and Taiex programs), and at the Council of Europe, as well as the contribution to many hearings, meetings and workshops held also by Parliaments and to specialized book journals and papers.
He currently teaches on privacy at the Luiss University, Rome.
Before joining the EDPS, he worked as Secretary General to the Italian Data Protection Authority, a position he occupied from 1997 to 2009. A member of the Italian judiciary with the rank of Cassation judge, he has attended to many initiatives and committees on data protection and related issues at international level.
The experience on data protection includes the participation in many bodies at European Union level (including Art. 31 Committee of Directive n. 95/46/EC and Taiex programs), and at the Council of Europe, as well as the contribution to many hearings, meetings and workshops held also by Parliaments and to specialized book journals and papers.
He currently teaches on privacy at the Luiss University, Rome.
Chi Chen, MS, CFE, CISA
Forensic Technology Partner, EY, Shanghai, China (Moderator)
Forensic Technology Partner, EY, Shanghai, China (Moderator)
Mr. Chi Chen is a technology partner in EY’s Forensic & Integrity Services (FIS) practice. He specializes in data compliance, IP and personal data privacy protection, predictive risk analytics, proactive compliance monitoring and management systems, fraud detection analytics, antitrust analytics, and eDiscovery. All of which require in-depth analysis of large, disparate sets of financial, operational and transactional data. Chi led his team to help clients identify high risk transactions or behaviors timely, efficiently, and effectively by leveraging advanced data analytics techniques including but not limited to data visualization, statistical modeling, text mining, and digital forensics. Chi has more than 15 years of combined advisory and audit experience in the United States, Australia and China. He has served many Fortune 500 and multinational companies in a variety of industries including pharmaceutical, medical devices, and healthcare.
9:00 am
US DOJ and SEC FCPA Enforcement Update
Charles Cain, JD
Chief, FCPA Unit, US Securities and Exchange Commission (SEC), Washington, DC, USA
Chief, FCPA Unit, US Securities and Exchange Commission (SEC), Washington, DC, USA
Charles Cain is the Chief of the Foreign Corrupt Practices Act Unit within the Securities and Exchange Commission’s Division of Enforcement. He has been in the SEC’s FCPA Unit since its formation and with the Division of Enforcement for seventeen years. As the Deputy Chief, his roles include oversight of the National FPCA program, coordination with the DOJ and FBI, and supervision of individual investigations. During his tenure with the SEC, he has been responsible for numerous significant FCPA matters, as well as cases across a broad range of other areas including financial fraud, insider trading, offering fraud, market manipulation, disclosure fraud, and broker dealer practice
Tarek Helou, JD
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice; Former Assistant US Attorney, Northern District of California, Washington, DC, USA
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice; Former Assistant US Attorney, Northern District of California, Washington, DC, USA
Tarek Helou is an Assistant Chief in the U.S. Department of Justice’s Foreign Corrupt Practices Act Unit. He has worked in the FCPA Unit since 2012. As an Assistant Chief, Tarek supervises other prosecutors who work with law enforcement agents to investigate and charge violations of the FCPA and related criminal laws. He was an Assistant U.S. Attorney in San Francisco from 2007 to 2012, where he prosecuted cases involving drug trafficking, firearms offenses, racketeering, money laundering, tax violations, child exploitation, fraud, and immigration offenses. From 2001 to 2007, Tarek was an associate at Orrick, Herrington, and Sutcliffe in Silicon Valley and San Francisco.
Gary F. Giampetruzzi, JD
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head, Government Investigations, Pfizer Inc., New York, NY, USA (Co-moderator)
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head, Government Investigations, Pfizer Inc., New York, NY, USA (Co-moderator)
Gary Giampetruzzi is a partner in the Investigations and White-Collar practice in the Litigation Department at 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), State Attorney General consumer protection statutes, 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. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.
Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.
Haiyan Tang, JD, PhD
Partner, Paul Hastings; Former Acting Compliance Regional Director in China, Pfizer, Shanghai, China (Co-moderator)
Partner, Paul Hastings; Former Acting Compliance Regional Director in China, Pfizer, Shanghai, China (Co-moderator)
Haiyan Tang is a Litigation partner and the Chief Representative of the Paul Hastings Shanghai office. Ms. Tang’s practice focuses on global government enforcement proceedings, internal investigations, and dispute resolutions. Ms. Tang has advised numerous multinational companies on sensitive enforcement matters and internal investigations involving the Foreign Corrupt Practices Act, the Bribery Act, anticorruption regulations, healthcare programs, government sanctions, export control, business ethics requirements, securities laws, accounting/ bookkeeping standards, and other internal financial control.
Ms. Tang served as the Regional Director of a leading global pharmaceutical company while it was fulfilling its self-reporting obligation to the United States Department of Justice and the United States Securities and Exchange Commission. Ms. Tang also worked at the Silicon Valley office of a leading international law firm, representing multiple high-tech companies in U.S. intellectual property litigation.
Ms. Tang served as the Regional Director of a leading global pharmaceutical company while it was fulfilling its self-reporting obligation to the United States Department of Justice and the United States Securities and Exchange Commission. Ms. Tang also worked at the Silicon Valley office of a leading international law firm, representing multiple high-tech companies in U.S. intellectual property litigation.
9:45 am
Results of the 2018 Deloitte Asia Pac Life Science Compliance Survey
Gareth Lee
Vice President, Legal and Compliance, Asia Pacific, Cardinal Health; Former General Counsel and Head of Compliance, Asia Pacific, Allergan; Former Co-chair, Asia Pac Pharma Compliance Congress, Singapore
Vice President, Legal and Compliance, Asia Pacific, Cardinal Health; Former General Counsel and Head of Compliance, Asia Pacific, Allergan; Former Co-chair, Asia Pac Pharma Compliance Congress, Singapore
Gareth Lee is Vice President, Legal & Compliance for the Asia Pacific region at Cardinal Health and a member of its Global Legal & Compliance Committee, which is tasked with driving the company’s legal & compliance strategy as it expands its global footprint. He also serves on Cardinal Health’s Asia Pacific leadership team where he provides broad and risk-weighted perspectives on business strategies and operations. With 24 years of experience as a legal professional, Gareth started his legal career in 1995 as a solicitor in the commercial & banking practice of a leading Singapore law firm and thereafter as legal counsel with increasing scope and responsibilities in companies like Royal Dutch Shell and Halliburton. Gareth first came to the healthcare industry in 2006 when he was appointed Baxter Healthcare’s Senior Counsel, India & South East Asia. Between 2009 – May 2015, Gareth served as Allergan’s General Counsel & Chief Compliance Officer, Asia Pacific.
Maria “Maru” Quindimil, MBA
APAC Ethics and Compliance Lead, UCB Pharma; Former Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Shanghai, China
APAC Ethics and Compliance Lead, UCB Pharma; Former Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Shanghai, China
Maria Eugenia (Maru) Quindimil is currently APAC Ethics and Compliance Head for UCB. She handles an extensive geography, from Japan to India to Australia and leads the team of 20 people between direct and indirect reports. She is handling not only internal compliance processes but also third parties and alliance management for APAC. Previously, Maru was Senior Director APAC at GEC Risk Advisory LLC, and Executive Director, Regional Compliance Officer, Asia for Merck Sharp & Dohme, Asia Ltd. Throughout a career that has spanned 28 years, Maru has applied her background in pharmaceutical and pharmacological research into the commercial pharmaceutical sector where she led the development, launch and market growth of several new products across a diverse range of geographic sectors. Maru has led APEC Pharmaceutical sector meetings for the implementation of Pharmaceutical codes of conduct and active contributor in AP Compliance Network.
Mohit Grover, MA
Life Sciences and Healthcare Sustainability Leader, Strategic and Reputation Risk Leader, Risk Advisory, Deloitte; Former IS Lead, Global Commercial Organization, Astra Zeneca, Singapore (Moderator)
Life Sciences and Healthcare Sustainability Leader, Strategic and Reputation Risk Leader, Risk Advisory, Deloitte; Former IS Lead, Global Commercial Organization, Astra Zeneca, Singapore (Moderator)
Mohit Grover is an Executive Director in Risk Consulting and leads the Life Sciences & Health Care industry in Southeast Asia. He is currently a Partner with Deloitte and was previously the IS Lead, Global Commercial Organization at Astra Zeneca. With 20 years of experience in Consulting and Life Sciences industries, he possesses in-depth expertise in enabling business growth strategies, transformations in Sales & Marketing, Finance and IT functions. He has extensive experience in delivering shared services, digital, enterprise applications and outsourcing initiatives.
10:30 am
Break
11:00 am
Annual Asia Pac Anticorruption Roundtable
Eugene Chen, Esq.
Partner, Beijing Office, Hogan Lovells International LLP, Shanghai, China
Partner, Beijing Office, Hogan Lovells International LLP, Shanghai, China
Eugene Chen is a partner based in Hogan Lovells’ Shanghai office, and is one of the few US-trained and experienced litigators located full-time in China to advise clients regarding advantages and liabilities of international dispute resolution. His practice focuses on cross-border disputes and investigations in the United States, China, and elsewhere in Asia. Eugene began his career as a food and drug regulatory lawyer in Washington, DC, and has extensive litigation, compliance, and regulatory experience with the life sciences industry. For the past eleven years, he has assisted clients with anti-corruption investigations and policy development in China, as well as enforcement actions by Chinese and U.S. authorities.
Kyungsun “Kyle” Choi
Foreign Attorney, Health and Digital Healthcare Practice, Kim & Chang Law Firm
Foreign Attorney, Health and Digital Healthcare Practice, Kim & Chang Law Firm
Kyungsun Kyle Choi is a foreign attorney in the Health and Digital Healthcare Practice at Kim & Chang. She is also a member of the Mergers & Acquisitions and Corporate Investigations & White-Collar Defense Practice. Ms. Choi advises chemical and related industry clients including consumer goods on EH&S regulations that have been undergoing rapid changes with focused enforcement activities.
Ms. Choi represents a broad range of companies in the pharmaceutical/medical device/food/cosmetic sectors, specializing in pharmaceutical regulation, pricing and reimbursement, compliance, bribery and competition law issues relating to promotional and marketing practices in the industry, anti- counterfeiting strategies, M&A, and restructuring of business operations.
Ms. Choi’s representative work in recent years includes advising pharmaceutical clients in negotiating price and reimbursement scope of innovative drugs as well as in renewal of contract under a Risk Sharing Program.
Ms. Choi represents a broad range of companies in the pharmaceutical/medical device/food/cosmetic sectors, specializing in pharmaceutical regulation, pricing and reimbursement, compliance, bribery and competition law issues relating to promotional and marketing practices in the industry, anti- counterfeiting strategies, M&A, and restructuring of business operations.
Ms. Choi’s representative work in recent years includes advising pharmaceutical clients in negotiating price and reimbursement scope of innovative drugs as well as in renewal of contract under a Risk Sharing Program.
Michael K. Loucks, JD
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice, Washington, DC
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice, Washington, DC
Michael Loucks is an experienced trial and appellate attorney whose practice focuses on internal investigations and government enforcement matters in the U.S. and abroad, and on false claims act litigation in federal and state courts. Prior to joining Skadden in 2010, Mr. Loucks served as acting U.S. attorney and first assistant U.S. attorney for the District of Massachusetts. He repeatedly has been selected for inclusion in Chambers USA: and The Best Lawyers in America.
Vivian Robinson, Esq.
Partner, McGuireWoods LLP; 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
Partner, McGuireWoods LLP; 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
Vivian Robinson QC became a barrister in 1967 and practiced at the English criminal bar for over forty years, acting for both prosecution and defense. He sat as a part-time judge for over thirty years. He was appointed Queen’s Counsel in 1986, became Head of QEB Hollis Whiteman Chambers and served as Treasurer of Inner Temple.
He left the practicing law to take up appointment as first General Counsel at the Serious Fraud Office. In this capacity he played a prominent role in the development of the SFO’s enforcement strategy on the UK Bribery Act 2010 and was the SFO’s principal liaison with the business community on this subject.
He is a member of McGuireWoods’ Government Investigations & White-Collar Litigation team. He is a co-author of “The FCPA and UK Bribery Act – A Ready Reference for Business and Lawyers”, published by the American Bar Association.
He left the practicing law to take up appointment as first General Counsel at the Serious Fraud Office. In this capacity he played a prominent role in the development of the SFO’s enforcement strategy on the UK Bribery Act 2010 and was the SFO’s principal liaison with the business community on this subject.
He is a member of McGuireWoods’ Government Investigations & White-Collar Litigation team. He is a co-author of “The FCPA and UK Bribery Act – A Ready Reference for Business and Lawyers”, published by the American Bar Association.
Yee Chung Seck
Partner, Baker McKenzie (Vietnam) Ltd., Ho Chi Minh City, Vietnam
Partner, Baker McKenzie (Vietnam) Ltd., Ho Chi Minh City, Vietnam
Yee Chung Seck is a Partner with Baker McKenzie in Vietnam. He is highly regarded in his field – Chambers Global, Chambers Asia, IFLR1000, and Asia Pacific Legal 500.
He has dealt with a wide range of investment projects and major M&A deals, and advised and assisted on corporate, commercial and regulatory compliance matters. This includes foreign direct investment, market access and licensing, private and public M&A, commercial contracts, competition and anti-corruption compliance, data privacy and management, over a diverse range of industries, including pharmaceuticals and healthcare, cosmetics, e-commerce, IT services, consumer products, food & beverage, manufacturing, property, and aviation.
He has dealt with a wide range of investment projects and major M&A deals, and advised and assisted on corporate, commercial and regulatory compliance matters. This includes foreign direct investment, market access and licensing, private and public M&A, commercial contracts, competition and anti-corruption compliance, data privacy and management, over a diverse range of industries, including pharmaceuticals and healthcare, cosmetics, e-commerce, IT services, consumer products, food & beverage, manufacturing, property, and aviation.
Stacy Chai
Partner, Forensic & Integrity Services, EY, Singapore (Moderator)
Partner, Forensic & Integrity Services, EY, Singapore (Moderator)
Stacy Chai is a Partner, Forensic and Integrity Services with Ernst & Young Singapore’s Fraud Investigations & Dispute Services. She has experience in the areas of accounting, financial audit, internal controls review and investigations in the Asia region.
Stacy’s areas of specialization include investigations involving employee misconduct, corruption and fraud; litigation support and forensic due diligence projects to assist clients in address integrity and corruption risks. Her portfolio of clients includes Pharmaceutical, Airlines, Service, Retail and Manufacturing.
Stacy is a guest speaker on fraud for Singapore universities and she regularly conducts fraud training for her clients.
Stacy’s areas of specialization include investigations involving employee misconduct, corruption and fraud; litigation support and forensic due diligence projects to assist clients in address integrity and corruption risks. Her portfolio of clients includes Pharmaceutical, Airlines, Service, Retail and Manufacturing.
Stacy is a guest speaker on fraud for Singapore universities and she regularly conducts fraud training for her clients.
12:00 pm
Networking Luncheon
MINI SUMMITS BLOCK A: 1:00 pm – 2:00 pm
Mini Summit 1: Asia Pac Hot Compliance Markets Updates, Further Details and Q&A
1:00 pm
Introductions, Discussion and Q&A
China
Lei Li, LLM
Partner, Sidley Austin; Former Third Secretary, Ministry of Commerce, People’s Republic of China, Beijing, China
Lei Li, LLM
Partner, Sidley Austin; Former Third Secretary, Ministry of Commerce, People’s Republic of China, Beijing, China
Indonesia
Cahyani Endahayu
Partner, Baker McKenzie, Jakarta, Indonesia
Cahyani Endahayu
Partner, Baker McKenzie, Jakarta, Indonesia
Cahyani Endahayu is a Partner in the Mergers & Acquisitions Practice Group. Her work includes handling the corporate/licensing, compliance and day-to-day work of several of the Firm’s major clients and providing corporate, compliance and advisory support services to other clients in relation to corporate/commercial issues. She has advised a wide range of domestic and international clients across various industry sectors, including pharmaceutical and retail/trading. Cahyani’s experience includes the representation of various pharmaceutical companies and providing regulatory advice on investment, product registrations (including transfer of registration of drug products) and licensing requirements at the local authorities. Her past experience includes representing multi-national pharmaceutical manufacturing companies in areas of contracts, clinical/observational studies contracts/agreements, providing regulatory advice on product labelling, compliance with Indonesian anti-corruption law and antitrust related matters. She is a Member of the Indonesian Advocates Association (PERADI).
Korea
Yunjoh Lee, B.Jur, LL.M
Attorney, Kim & Chang Law Firm
Yunjoh Lee, B.Jur, LL.M
Attorney, Kim & Chang Law Firm
Yunjoh Lee is an attorney at Kim & Chang. She practices primarily in health and antitrust and competition.
Ms. Lee counsels multinational clients in the pharmaceutical, medical device and food industries on Korean regulatory compliance, corporate governance, competition law issues, and general corporate and commercial law matters. In particular, Ms. Lee counsels drug and device clients on various facets of anti-corruption compliance, such as designing and implementing effective compliance programs, employee training, monitoring, internal investigations, corrective action and remedial measures.
Her representative matters include representing pharmaceutical companies in investigations by the Korea Fair Trade Commission into alleged competition law violations relating to marketing and sales practices and defending pharmaceutical companies before the Korea Fair Trade Commission and the Ministry of Food & Drug Safety on charges of illegal interactions with healthcare professionals.
Ms. Lee counsels multinational clients in the pharmaceutical, medical device and food industries on Korean regulatory compliance, corporate governance, competition law issues, and general corporate and commercial law matters. In particular, Ms. Lee counsels drug and device clients on various facets of anti-corruption compliance, such as designing and implementing effective compliance programs, employee training, monitoring, internal investigations, corrective action and remedial measures.
Her representative matters include representing pharmaceutical companies in investigations by the Korea Fair Trade Commission into alleged competition law violations relating to marketing and sales practices and defending pharmaceutical companies before the Korea Fair Trade Commission and the Ministry of Food & Drug Safety on charges of illegal interactions with healthcare professionals.
Malaysia
Eddie Chuah
Partner, Dispute Resolution Practice Group, Wong Partners, Kuala Lumpur, Malaysia
Eddie Chuah
Partner, Dispute Resolution Practice Group, Wong Partners, Kuala Lumpur, Malaysia
Eddie Chuah is a partner with the Dispute Resolution Practice Group, with experience in all aspects of civil litigation, arbitration, industrial relations disputes and compliance.
Eddie has undertaken a wide variety of briefs involving substantive law issues ranging from complex commercial transactions, insolvency litigation, shareholder disputes, construction, employment and administrative law. He also focuses on compliance issues, in particular, anti-corruption investigation, government procurement, audit and prevention.
Eddie regularly advises and assists both domestic and multinational corporations on a broad range of risk-related issues in compliance with both local and foreign authorities. His experience includes conducting internal investigations and audits, developing internal policies and procedures, as well as providing the necessary training to mitigate risks of fraud and corruption.
He has assisted and represented major corporations on external investigations by the Department of Justice and Securities Exchange Commission, the United Kingdom Serious Fraud Office, Singapore Corrupt Practices Investigation Bureau as well as the Malaysian Anti-Corruption Commission Agency.
Eddie has undertaken a wide variety of briefs involving substantive law issues ranging from complex commercial transactions, insolvency litigation, shareholder disputes, construction, employment and administrative law. He also focuses on compliance issues, in particular, anti-corruption investigation, government procurement, audit and prevention.
Eddie regularly advises and assists both domestic and multinational corporations on a broad range of risk-related issues in compliance with both local and foreign authorities. His experience includes conducting internal investigations and audits, developing internal policies and procedures, as well as providing the necessary training to mitigate risks of fraud and corruption.
He has assisted and represented major corporations on external investigations by the Department of Justice and Securities Exchange Commission, the United Kingdom Serious Fraud Office, Singapore Corrupt Practices Investigation Bureau as well as the Malaysian Anti-Corruption Commission Agency.
Vietnam
Anh Nguyen Xuan, MBA
Chief Compliance Officer, Vietnam and Indochina, Sanofi Aventis, Ho Chi Minh City, Vietnam
Anh Nguyen Xuan, MBA
Chief Compliance Officer, Vietnam and Indochina, Sanofi Aventis, Ho Chi Minh City, Vietnam
Mr. Nguyen Xuan is the Chief of Compliance Officer (Vietnam/ Indochina) for Sanofi Aventis. Previously, he was the Head of Compliance at CHUBB Life Vietnam. He also held several roles at Metro Cash & Carry, including Head of Security, Audit and Compliance, Head of Security, Head of LPO and Compliance, Head of Audit & Local Program Office (LPO) and Head of Audit.
Maria “Maru” Quindimil, MBA
APAC Ethics and Compliance Lead, UCB Pharma; Former Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Shanghai, China (Moderator)
APAC Ethics and Compliance Lead, UCB Pharma; Former Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Shanghai, China (Moderator)
Maria Eugenia (Maru) Quindimil is currently APAC Ethics and Compliance Head for UCB. She handles an extensive geography, from Japan to India to Australia and leads the team of 20 people between direct and indirect reports. She is handling not only internal compliance processes but also third parties and alliance management for APAC. Previously, Maru was Senior Director APAC at GEC Risk Advisory LLC, and Executive Director, Regional Compliance Officer, Asia for Merck Sharp & Dohme, Asia Ltd. Throughout a career that has spanned 28 years, Maru has applied her background in pharmaceutical and pharmacological research into the commercial pharmaceutical sector where she led the development, launch and market growth of several new products across a diverse range of geographic sectors. Maru has led APEC Pharmaceutical sector meetings for the implementation of Pharmaceutical codes of conduct and active contributor in AP Compliance Network.
Mini Summit 2: Annual Medical Device Compliance Roundtable
1:00 pm
Introductions, Discussion and Q&A
Campbell Clark, LLB, MJ
Chief Ethics and Compliance Officer, Asia Pacific, Medtronic, Covidien Private Limited; Chair, Legal, Ethics and Compliance Committee, Asia Pacific Medical Technology Association (APACMed), Singapore
Chief Ethics and Compliance Officer, Asia Pacific, Medtronic, Covidien Private Limited; Chair, Legal, Ethics and Compliance Committee, Asia Pacific Medical Technology Association (APACMed), Singapore
Campbell Clark is Vice President, Legal and Compliance, Asia Pacific, for Medtronic, a healthcare company, and is based in Singapore. He was previously Chief Ethics & Compliance Officer, Asia Pacific, for Medtronic. Prior to Medtronic’s acquisition of Covidien in 2015, he was General Counsel, Asia, for Covidien. Campbell has also held senior roles in-house as an international legal counsel in Australia and Japan, and in private practice as a litigation lawyer in New Zealand and the United Kingdom. Since 2015 Campbell has been the Chair of the Legal/Ethics & Compliance Committee of the Asia Pacific Medical Technology Association (APACMed).
Jasmine Karimi, LLB, LLM
Senior Director and Counsel, APAC, Illumina, Former President, Hong Kong Corporate Counsel Association, Singapore
Senior Director and Counsel, APAC, Illumina, Former President, Hong Kong Corporate Counsel Association, Singapore
Jasmine Karimi has worked in law firms and MNCs in the US, UK, Canada, Hong Kong & Singapore, across diverse sectors (Media, Manufacturing, Luxury Goods and Biotech). Most recently, she was the Senior Director and Counsel, APAC for Illumina Inc. She is also part of APAC Management, Global Legal Management and leads the Women’s Leadership Network for the company in Singapore. She is admitted to practice law in England & Wales, Singapore, Canada, and Hong Kong. A firm believer in giving back, Jasmine has served on several boards and is the immediate past President of the Hong Kong Corporate Counsel Association (HKCCA). She currently sits on the SIAC Users Council. Jasmine has been named as one of the leading influential in-house lawyers in business in Asia in The Legal 500: Corporate Counsel 100 Asia 2014.
Benjamin Kwak, JD
Vice President, Compliance Officer and Senior Legal Counsel, Asia Pacific, Zimmer Biomet, Singapore
Vice President, Compliance Officer and Senior Legal Counsel, Asia Pacific, Zimmer Biomet, Singapore
John Tsai
Forensic Partner, Fraud Investigation & Dispute Services, EY, Shanghai, China (Moderator)
Forensic Partner, Fraud Investigation & Dispute Services, EY, Shanghai, China (Moderator)
Mini Summit 3: Pharma Pricing Compliance Issues Updates
1:00 pm
Update on Drug Pricing Reductions and Control in the US
Michael K. Loucks, JD
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice, Washington, DC, USA
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice, Washington, DC, USA
Michael Loucks is an experienced trial and appellate attorney whose practice focuses on internal investigations and government enforcement matters in the U.S. and abroad, and on false claims act litigation in federal and state courts. Prior to joining Skadden in 2010, Mr. Loucks served as acting U.S. attorney and first assistant U.S. attorney for the District of Massachusetts. He repeatedly has been selected for inclusion in Chambers USA: and The Best Lawyers in America.
The Future of Pharma-Private Insurance Collaborations in Asia Pacific
Sol Magaz, MBA
Senior Principal, IQVIA, Singapore
Senior Principal, IQVIA, Singapore
Mini Summit 4: A Practical Approach to Investigations – An exploration of how investigations fit within an organisations response to identified issue and an introduction to parts 1 to 5 of a progressive proactive investigative model.
1:00 pm
Introductions, Discussion and Q&A
Bob Pointer
Learning and Development Specialist, Course Design and Delivery Partner, REL Alliance Singapore, Berry Hill, Gloucestershire, UK
Learning and Development Specialist, Course Design and Delivery Partner, REL Alliance Singapore, Berry Hill, Gloucestershire, UK
Bob Pointer is a professional development and education professional specializing in the role and dynamics of humans in business and the link between security and productivity. Bob was a career detective with the City of London Police working primarily in the investigation of serious and organized crime. Following retirement from the Police service he took up a role as a lecturer at City -The University of London and was instrumental in the forming of the Centre for Security, Investigations and Police Sciences. During this time he provided Fraud investigation and prevention seminars on behalf of OLAF (the European Fraud Agency) in Romania, Bulgaria and Croatia. Additionally, he designed and delivered courses for the U.K. Serious Fraud Office, Medicines Agency and the Financial Ombudsman. Since 2011 he was worked as an independent consultant across 5 continents with many multi-national organizations.
Presentation Material (Acrobat)
Interview Plan (Acrobat)
Investigation Plan (Acrobat)
2:00 pm
Transition Break
MINI SUMMITS BLOCK B: 2:15 pm – 3:15 pm
Mini Summit 5: Chinese Anticorruption and Compliance Best Practices Roundtable
2:15 pm
Introductions, Discussion and Q&A
Vanessa Han Juhn
Head of Compliance, China, Novo Nordisk, Shanghai, China
Head of Compliance, China, Novo Nordisk, Shanghai, China
Vanessa Han is the Compliance Director of Novo Nordisk (China) Pharmaceuticals Co., Ltd. Vanessa has more than 12 years of combined Finance, Internal Control and Legal & Compliance experience in the Pharm industry, she has worked at China, Denmark and the US for taking a wide range of responsibility on Compliance, financial management, audit and internal control. She is experienced with setting up corporate governance with compliance mechanism, actively working with industry committee as core member for shaping industry code of conduct. Vanessa holds a combined background of Law, Finance and Charted Certificated Accountant, UK.
Christine Ng
Head, Ethics and Compliance Officer, Greater China, GSK, Shanghai, China
Head, Ethics and Compliance Officer, Greater China, GSK, Shanghai, China
Jonathan Shun Wah, PCLL
Assistant General Counsel, Greater China and APAC (ex South Asia) Investigations Lead, Pfizer, Hong Kong
Assistant General Counsel, Greater China and APAC (ex South Asia) Investigations Lead, Pfizer, Hong Kong
Jonathan Shun Wah is Assistant General Counsel – Greater China and APAC Investigations Lead at Pfizer Inc, based in Hong Kong. Mr. Shun Wah is a qualified lawyer in Hong Kong and England & Wales. Prior to joining Pfizer, he worked in the Hong Kong offices of Orrick, Herrington & Sutcliffe and Dechert LLP. Mr. Shun Wah has been involved in FCPA and other internal investigations around Asia for the last nine years.
Angela M. Xenakis, MBA, JD
Partner, Sidley Austin LLP, Singapore (Moderator)
Partner, Sidley Austin LLP, Singapore (Moderator)
Angie Xenakis is a partner in Sidley Austin’s Singapore office, focusing primarily on internal investigations, government enforcement and compliance counseling. Before relocating to Singapore, Angie practiced in the firm’s Washington, D.C. office for fourteen years.
Angie has represented a wide variety of clients from across major industries, including pharmaceutical, medical devices, manufacturing, financial, defense, energy, consumer products and distribution. She has substantial experience advising multinational companies on all types of investigations and compliance matters under the U.S. Foreign Corrupt Practices Act (FCPA). She also has handled matters involving, among other things, healthcare fraud, securities fraud, false claims, accounting fraud, sanctions violations, anti-money laundering and insider trading. Angie has conducted numerous internal investigations throughout the U.S., as well as Asia, Europe, Africa, South America and the Middle East.
Angie has represented a wide variety of clients from across major industries, including pharmaceutical, medical devices, manufacturing, financial, defense, energy, consumer products and distribution. She has substantial experience advising multinational companies on all types of investigations and compliance matters under the U.S. Foreign Corrupt Practices Act (FCPA). She also has handled matters involving, among other things, healthcare fraud, securities fraud, false claims, accounting fraud, sanctions violations, anti-money laundering and insider trading. Angie has conducted numerous internal investigations throughout the U.S., as well as Asia, Europe, Africa, South America and the Middle East.
Mini Summit 6: Transparency Reporting Challenges and Approaches: Learning from Global Experience and Overview of
the latest Transparency Reporting in Asia
2:15 pm
Introductions, Panel Discussion and Q&A
Yoo-Kyung (Karen) Choi, JD, LLM
Korea Compliance Lead, Pfizer, Seoul, South Korea
Korea Compliance Lead, Pfizer, Seoul, South Korea
Ms. Yoo-kyung (Karen) Choi is Compliance Lead of Pfizer Korea. Prior to this, she assumed the role of Compliance Lead of Pfizer Japan. Karen provides proactive compliance advice and oversees compliance programs in line with domestic and international anti-bribery and corruption policies and laws. She also worked on various business development transactions in APAC region as a compliance counsel. She is a member of the Law Society of Upper Canada.
Justus Chua
Head of Legal and Compliance, South East Asia and South Korea Boehringer Ingelheim; Former Regional Counsel, (Developing Markets), Reckitt Benckiser Pharmaceuticals, Singapore
Head of Legal and Compliance, South East Asia and South Korea Boehringer Ingelheim; Former Regional Counsel, (Developing Markets), Reckitt Benckiser Pharmaceuticals, Singapore
Justus is the Head of Legal & Compliance, ROPU SEASK At Boehringer Ingelheim Singapore Pte Ltd.
Katsumi Kojima
Member, Code Compliance Committee (APEC Forum Taskforce Leader), Japan Pharmaceutical Manufacturers’ Association, Tokyo, Japan
Member, Code Compliance Committee (APEC Forum Taskforce Leader), Japan Pharmaceutical Manufacturers’ Association, Tokyo, Japan
Katsumi Kojima is a Code Compliance Committee member of the Japan Pharmaceutical Manufacturers’ Association (JPMA) and serves as a leader of APEC Forum Taskforce. He has been working in the compliance field in both pharmaceutical and medical device industries for over 10 years and been a speaker and a panelist on various conferences, such as APEC Business Ethicsa for SMEs Forum (2014 – 2018), the Japan Society for Business Ethics (2017 and 2018), and the Waseda Medical Academic.
Carol Shi
Area Compliance Director, Asia and ANZ, Astrazeneca, Singapore
Area Compliance Director, Asia and ANZ, Astrazeneca, Singapore
Carol Shi is a Compliance Director Asia Area and ANZ for AstraZeneca. She is a well-rounded finance and compliance professional with extensive international experience matched by proven leadership qualities.
She is recognized as a top performer with business acumen and a strong, disciplined approach, backed by skills and abilities honed in a wide range of challenging appointments within the Pharmaceutical, FMCG and Chemical Industries. Carol has operational experience in managing risks, change, organisational rationalisation as well as executing growth strategies.
She is recognized as a top performer with business acumen and a strong, disciplined approach, backed by skills and abilities honed in a wide range of challenging appointments within the Pharmaceutical, FMCG and Chemical Industries. Carol has operational experience in managing risks, change, organisational rationalisation as well as executing growth strategies.
Albert van Maaren, MsC
Regional Compliance Officer Healthcare APAC, Group Compliance, Merck KGaA, Singapore
Regional Compliance Officer Healthcare APAC, Group Compliance, Merck KGaA, Singapore
Albert van Maaren is the Regional Compliance Officer Healthcare APAC (including China and Japan) for Merck KGaA. Albert has over 20 years of experience and achievements in the pharmaceutical field, including regulatory affairs, pharmacovigilance, quality assurance, market access, and compliance. Prior to his regional compliance role in Singapore, Albert was also dedicated compliance officer for the Benelux countries and Portugal. Albert graduated with a Pharmaceutical degree from Utrecht University, the Netherlands, and completed his Executive Master of Compliance at VU University in Amsterdam (Compliance and Integrity Management).
Joyce Wong
Managing Director, Polaris Asia-Pacific; Former General Manager, Eli Lilly Asia Inc., Hong Kong (Moderator)
Managing Director, Polaris Asia-Pacific; Former General Manager, Eli Lilly Asia Inc., Hong Kong (Moderator)
Joyce Wong is Polaris’ Managing Director for Asia-Pacific, providing compliance technology and software solutions as well as insightful consulting and guidance to life science companies throughout the region to help companies solve their toughest compliance and transparency challenges. Joyce has more than 16 years’ experience in pharmaceutical industry, including a strong background in compliance and regulatory affairs, as well as project management, new product launch, strategic planning, marketing and business management. Prior to joining Polaris, Joyce served as General Manager for Eli Lilly Asia, Inc, responsible for managing the organization to deliver business results and achieve the highest standards across all areas of business.
Mini Summit 7: A Practical Approach to Investigations – Focusing on parts 6-10 of the investigative model covering evidence gathering ,case building and reporting outcomes
2:15 pm
Introductions, Panel Discussion and Q&A
Bob Pointer
Learning and Development Specialist, Course Design and Delivery Partner, REL Alliance Singapore, Berry Hill, Gloucestershire, UK
Learning and Development Specialist, Course Design and Delivery Partner, REL Alliance Singapore, Berry Hill, Gloucestershire, UK
Bob Pointer is a professional development and education professional specializing in the role and dynamics of humans in business and the link between security and productivity. Bob was a career detective with the City of London Police working primarily in the investigation of serious and organized crime. Following retirement from the Police service he took up a role as a lecturer at City -The University of London and was instrumental in the forming of the Centre for Security, Investigations and Police Sciences. During this time he provided Fraud investigation and prevention seminars on behalf of OLAF (the European Fraud Agency) in Romania, Bulgaria and Croatia. Additionally, he designed and delivered courses for the U.K. Serious Fraud Office, Medicines Agency and the Financial Ombudsman. Since 2011 he was worked as an independent consultant across 5 continents with many multi-national organizations.
Presentation Material (Acrobat)
Interview Plan (Acrobat)
Investigation Plan (Acrobat)
3:15 pm
Transition Break
MINI SUMMITS BLOCK C 3:30 pm – 4:30 pm
Mini Summit 8: Data Privacy Updates re the Impact of the GDPR and other Data Security Laws in Asia on the Asia PAC
Operations of Multinational Pharma and MedTech Companies
3:30 pm
Introductions, Panel Discussion and Q&A
Ken Chia
Principal and Member, Asia Pacific IT and Communications and Global Privacy Steering Committees, Baker McKenzie, Wong & Leow, Singapore
Principal and Member, Asia Pacific IT and Communications and Global Privacy Steering Committees, Baker McKenzie, Wong & Leow, Singapore
Sasha Kalb, JD
Vice President Risk and Compliance, American Express Global Business Travel, Former Senior APAC Compliance Counsel, 3M, Former Regional Compliance Counsel, Avon, Hong Kong
Vice President Risk and Compliance, American Express Global Business Travel, Former Senior APAC Compliance Counsel, 3M, Former Regional Compliance Counsel, Avon, Hong Kong
Sasha Kalb is VP for Compliance & Risk, Asia Pacific, Global Partnerships & Alliances. On an interim basis, she is also responsible for EMEA. Sasha joined American Express Global Business Travel in November 2014 as Vice President for Compliance & Risk APAC. Prior to this role, Sasha worked at 3M, where she was the company’s first APAC Compliance Counsel and built a brand as a trusted advisor who helped leaders grow their businesses in a complaint and sustainable manner. She also served as the APAC Regional Compliance Counsel for Avon Products, Inc.
Albert van Maaren, MsC
Regional Compliance Officer Healthcare APAC, Group Compliance, Merck KGaA, Singapore
Regional Compliance Officer Healthcare APAC, Group Compliance, Merck KGaA, Singapore
Albert van Maaren is the Regional Compliance Officer Healthcare APAC (including China and Japan) for Merck KGaA. Albert has over 20 years of experience and achievements in the pharmaceutical field, including regulatory affairs, pharmacovigilance, quality assurance, market access, and compliance. Prior to his regional compliance role in Singapore, Albert was also dedicated compliance officer for the Benelux countries and Portugal. Albert graduated with a Pharmaceutical degree from Utrecht University, the Netherlands, and completed his Executive Master of Compliance at VU University in Amsterdam (Compliance and Integrity Management).
Chi Chen, MS, CFE, CISA
Forensic Technology Partner, EY, Shanghai, China (Moderator)
Forensic Technology Partner, EY, Shanghai, China (Moderator)
Mr. Chi Chen is a technology partner in EY’s Forensic & Integrity Services (FIS) practice. He specializes in data compliance, IP and personal data privacy protection, predictive risk analytics, proactive compliance monitoring and management systems, fraud detection analytics, antitrust analytics, and eDiscovery. All of which require in-depth analysis of large, disparate sets of financial, operational and transactional data. Chi led his team to help clients identify high risk transactions or behaviors timely, efficiently, and effectively by leveraging advanced data analytics techniques including but not limited to data visualization, statistical modeling, text mining, and digital forensics. Chi has more than 15 years of combined advisory and audit experience in the United States, Australia and China. He has served many Fortune 500 and multinational companies in a variety of industries including pharmaceutical, medical devices, and healthcare.
Mini Summit 9: Using Data Analytics for Enhanced Compliance Monitoring
3:30 pm
Introductions, Discussion and Q&A
Peter Andres, MA, JD
Special Counsel, Baker McKenzie, Hong Kong
Special Counsel, Baker McKenzie, Hong Kong
Peter Andres is a Special Counsel in the Firm’s Compliance and Investigations practice group based in Hong Kong. Peter advises on a broad range of compliance matters, including due diligence, internal investigations, white collar criminal defense, and related civil litigation. He regularly handles business crimes investigations, with a focus on the U.S. Foreign Corrupt Practices Act (FCPA). Peter’s practice also involves advising on trade compliance issues that arise under US economic sanctions and export control laws. He advises on the extraterritorial application of these laws in cross border transactions, including mergers and acquisitions, joint venture arrangements, and other international commercial activities. Prior to joining the Hong Kong office, Peter worked in the Washington, D.C. and Sydney offices of the Firm. During his time in Washington, D.C., Peter spent significant time assisting in the representation of companies before the Department of Justice and the Securities and Exchange Commission on FCPA investigations.
Amy Huang, MBA
Director, Ethics & Compliance Business Liaise, Eli Lilly and Company, Shanghai
Director, Ethics & Compliance Business Liaise, Eli Lilly and Company, Shanghai
Amy Huang is Director of Ethics & Compliance for Eli Lilly and Company (Lilly) at its China affiliate. Ms. Huang has over 21 years of experience in the Life Sciences industry, primarily in the many disciplines of finance, and now more recently in ethics and compliance. Her international experience spans across Asia and North America. After many years of leading different teams in the field of finance, she brings the rich combination of industry, finance, and leadership experiences to the field of ethics and compliance, where she has been a champion of evolving the role into a critical strategic business partner. Currently, she leads a team of compliance officers, who inform business ethical decision making through monitoring, CAPAs, and business risk advising.
Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC, USA
Partner, Arnold & Porter LLP, Washington, DC, USA
As a Partner at Arnold & Porter, LLP, Keith Korenchuk counsels and advises global companies on regulatory and compliance matters worldwide, with a focus on compliance program effectiveness, compliance program implementation, operations and evaluation, and related regulatory counseling and advice. He works in a wide variety of industries and sectors including consumer products, electronics, energy, financial services, life sciences, medical device, pharmaceutical, and technology.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Maria “Maru” Quindimil, MBA
APAC Ethics and Compliance Lead, UCB Pharma; Former Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Shanghai, China
APAC Ethics and Compliance Lead, UCB Pharma; Former Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Shanghai, China
Maria Eugenia (Maru) Quindimil is currently APAC Ethics and Compliance Head for UCB. She handles an extensive geography, from Japan to India to Australia and leads the team of 20 people between direct and indirect reports. She is handling not only internal compliance processes but also third parties and alliance management for APAC. Previously, Maru was Senior Director APAC at GEC Risk Advisory LLC, and Executive Director, Regional Compliance Officer, Asia for Merck Sharp & Dohme, Asia Ltd. Throughout a career that has spanned 28 years, Maru has applied her background in pharmaceutical and pharmacological research into the commercial pharmaceutical sector where she led the development, launch and market growth of several new products across a diverse range of geographic sectors. Maru has led APEC Pharmaceutical sector meetings for the implementation of Pharmaceutical codes of conduct and active contributor in AP Compliance Network.
J. Mark Farrar, CPA, CFE, CFF
Managing Director, Navigant; Former Interim Global Chief Compliance Officer, Beckman Coulter, Atlanta, GA, USA (Moderator)
Managing Director, Navigant; Former Interim Global Chief Compliance Officer, Beckman Coulter, Atlanta, GA, USA (Moderator)
Mark Farrar is a Managing Director at Navigant and is the global leader of the Life Sciences Governance, Risk Management and Compliance Practice. Mark advises clients in the U.S., South America, Africa, Europe, and Asia on complex issues such as SEC financial accounting investigations, serving as the Independent Review Organization for those companies under a Corporate Integrity Agreement, preparing defense strategies for off-label allegations, anti-bribery and anti-corruption issues, pharmaceutical sales and marketing compliance, economic damages and lost profits settlement calculations, risk assessments, field force monitoring, transparency advisory services, data analytics, privacy compliance issues, and other various auditing and monitoring assessments. Mark served for over a year as the interim global Chief Compliance Officer for a large multi-billion-dollar medical device and diagnostics company with over 50 world-wide locations. He built the compliance program and established a global team, as well as implemented a comprehensive third party due diligence system to manage the anti-bribery/ anti-corruption risk of its distributors.
Mini Summit 10: A Practical Approach to Investigations – Humans are the primary source of information in any fact seeking enquiry and this session will look at formal and inform approaches to the process.
3:30 pm
Introductions, Panel Discussion and Q&A
Bob Pointer
Learning and Development Specialist, Course Design and Delivery Partner, REL Alliance Singapore, Berry Hill, Gloucestershire, UK
Learning and Development Specialist, Course Design and Delivery Partner, REL Alliance Singapore, Berry Hill, Gloucestershire, UK
Bob Pointer is a professional development and education professional specializing in the role and dynamics of humans in business and the link between security and productivity. Bob was a career detective with the City of London Police working primarily in the investigation of serious and organized crime. Following retirement from the Police service he took up a role as a lecturer at City -The University of London and was instrumental in the forming of the Centre for Security, Investigations and Police Sciences. During this time he provided Fraud investigation and prevention seminars on behalf of OLAF (the European Fraud Agency) in Romania, Bulgaria and Croatia. Additionally, he designed and delivered courses for the U.K. Serious Fraud Office, Medicines Agency and the Financial Ombudsman. Since 2011 he was worked as an independent consultant across 5 continents with many multi-national organizations.
Presentation Material (Acrobat)
Interview Plan (Acrobat)
Investigation Plan (Acrobat)
4:30 pm
Transition Break
MINI SUMMITS BLOCK D 4:45 pm – 5:45 pm
Mini Summit 11: Best Practices in HCP/HCO Management to Reduce Compliance Risk and Enhance Efficiency
4:45 pm
Introductions, Panel Discussion and Q&A
Uma Bhatt, PhD
Director, Technology Solutions, APAC, IQVIA; Former Senior Manager, Biostatistics and Data Operations, Daiichi Sankyo, Singapore
Director, Technology Solutions, APAC, IQVIA; Former Senior Manager, Biostatistics and Data Operations, Daiichi Sankyo, Singapore
Uma Bhatt leads the Technology Solutions GTM at IQVIA for Asia based out of Singapore. She has extensive experience in Life Sciences and Healthcare vertical (R&D and IT) in Asia, providing strategic direction and thought leadership for solution approaches and implementation support across Clinical and Commercial businesses. Her expertise lies in product development and innovative solutions around AI, Big Data, patient support platforms, patient adherence solutions, compliance and quality solutions besides CRM and other commercial offerings. She’s also a trained Biostatistician and has extensive experience in Pharma, Medtech and Consumer Health R&D projects across multinationals in US, EU and Asia. As a General Manager, she has managed 140+ associates across the globe for engagements in USA, Germany, Netherlands, China and India in various pharma functions on the R&D side like Biometrics, Pharmacovigilance, Medical Writing etc. and on the commercial side around Sales and Marketing operations, Compliance and Quality solutions.
Shinji Iizumi
Compliance Champion, Director, Corporate Planning Office, Ferring Pharmaceuticals, Tokyo, Japan
Compliance Champion, Director, Corporate Planning Office, Ferring Pharmaceuticals, Tokyo, Japan
Shinji Iizumi is the Compliance Champion (Local Compliance Officer) of Ferring Pharmaceuticals, Tokyo, Japan. He is responsible for establishing the compliance framework and the function. He is also involved in activities of Japan Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry, and a member of governance, legal & compliance committee of EFPIA Japan. Beside compliance, he is also responsible for variety of non-commercial roles (e.g. ethics coordinator, business development, external affairs, public affairs, NHI price negotiator with the Authorities, internal business review process coordinator, contact person for Patient Groups, etc.) as the Director of Corporate Planning Office. Before joining Ferring, Shinji worked for Univ. of Pennsylvania (in U.S.A), Roche, Chugai, Fournier Pharma, Solvay Pharma, and GSK (in Japan). He is in the pharmaceutical industry for 30 years, and has had extensive experiences in medical research, commercial/marketing, medical affairs, external affairs, public relations, business development, general manager roles, etc.
Catherine Healy Kanzler, JD
Executive Director, Global Compliance Operations, Compliance Department, Olympus Corporation of the Americas, Center Valley, PA, USA
Executive Director, Global Compliance Operations, Compliance Department, Olympus Corporation of the Americas, Center Valley, PA, USA
Catherine Kanzler is Executive Director, Global Compliance Operations of Olympus Corporation of the Americas. She is responsible for building and harmonizing compliance programs throughout the Olympus Group worldwide. She manages the Company’s Corporate Integrity Agreement, and is a key contributor to the management of its Deferred Prosecution Agreements. Cathy was a leader in the design of the Company’s compliance monitoring, testing and data analytics programs, grants and distributor due diligence requirements, and Compliance, Grants and HIPAA governance committees. She is leading the implementation of the Company’s global Hotline system. Prior to joining Olympus, she practiced law in New York, representing a range of clients in corporate and commercial litigation.
Vanessa Han Juhn
Head of Compliance, China, Novo Nordisk, Shanghai, China
Head of Compliance, China, Novo Nordisk, Shanghai, China
Vanessa Han is the Compliance Director of Novo Nordisk (China) Pharmaceuticals Co., Ltd. Vanessa has more than 12 years of combined Finance, Internal Control and Legal & Compliance experience in the Pharm industry, she has worked at China, Denmark and the US for taking a wide range of responsibility on Compliance, financial management, audit and internal control. She is experienced with setting up corporate governance with compliance mechanism, actively working with industry committee as core member for shaping industry code of conduct. Vanessa holds a combined background of Law, Finance and Charted Certificated Accountant, UK.
Joyce Wong
Managing Director, Polaris Asia-Pacific; Former General Manager, Eli Lilly Asia Inc., Hong Kong (Moderator)
Managing Director, Polaris Asia-Pacific; Former General Manager, Eli Lilly Asia Inc., Hong Kong (Moderator)
Joyce Wong is Polaris’ Managing Director for Asia-Pacific, providing compliance technology and software solutions as well as insightful consulting and guidance to life science companies throughout the region to help companies solve their toughest compliance and transparency challenges. Joyce has more than 16 years’ experience in pharmaceutical industry, including a strong background in compliance and regulatory affairs, as well as project management, new product launch, strategic planning, marketing and business management. Prior to joining Polaris, Joyce served as General Manager for Eli Lilly Asia, Inc, responsible for managing the organization to deliver business results and achieve the highest standards across all areas of business.
Mini Summit 12: The Role of the Compliance Officer in Cybersecurity
4:45 pm
Introductions, Panel Discussion and Q&A
Sasha Kalb, JD
Vice President Risk and Compliance, American Express Global Business Travel, Former Senior APAC Compliance Counsel, 3M, Former Regional Compliance Counsel, Avon, Hong Kong
Vice President Risk and Compliance, American Express Global Business Travel, Former Senior APAC Compliance Counsel, 3M, Former Regional Compliance Counsel, Avon, Hong Kong
Sasha Kalb is VP for Compliance & Risk, Asia Pacific, Global Partnerships & Alliances. On an interim basis, she is also responsible for EMEA. Sasha joined American Express Global Business Travel in November 2014 as Vice President for Compliance & Risk APAC. Prior to this role, Sasha worked at 3M, where she was the company’s first APAC Compliance Counsel and built a brand as a trusted advisor who helped leaders grow their businesses in a complaint and sustainable manner. She also served as the APAC Regional Compliance Counsel for Avon Products, Inc.
Haiyan Tang, JD, PhD
Partner, Paul Hastings; Former Acting Compliance Regional Director in China, Pfizer, Shanghai, China
Partner, Paul Hastings; Former Acting Compliance Regional Director in China, Pfizer, Shanghai, China
Haiyan Tang is a Litigation partner and the Chief Representative of the Paul Hastings Shanghai office. Ms. Tang’s practice focuses on global government enforcement proceedings, internal investigations, and dispute resolutions. Ms. Tang has advised numerous multinational companies on sensitive enforcement matters and internal investigations involving the Foreign Corrupt Practices Act, the Bribery Act, anticorruption regulations, healthcare programs, government sanctions, export control, business ethics requirements, securities laws, accounting/ bookkeeping standards, and other internal financial control.
Ms. Tang served as the Regional Director of a leading global pharmaceutical company while it was fulfilling its self-reporting obligation to the United States Department of Justice and the United States Securities and Exchange Commission. Ms. Tang also worked at the Silicon Valley office of a leading international law firm, representing multiple high-tech companies in U.S. intellectual property litigation.
Ms. Tang served as the Regional Director of a leading global pharmaceutical company while it was fulfilling its self-reporting obligation to the United States Department of Justice and the United States Securities and Exchange Commission. Ms. Tang also worked at the Silicon Valley office of a leading international law firm, representing multiple high-tech companies in U.S. intellectual property litigation.
Chris Fordham
Partner, Forensic and Integrity Services, EY, Hong Kong (Moderator)
Partner, Forensic and Integrity Services, EY, Hong Kong (Moderator)
Chris Fordham is a Partner in EY’s Forensic & Integrity Services team based in Hong Kong, where has lived for 20 years. During his many years working in the forensic accounting area, Chris has worked on a large number of forensic investigations dealing with fraud and corruption, including the US Foreign Corrupt Practices Act (FCPA), as well as being engaged on anti-money laundering risk consulting assignments, expect witness and general litigation support engagements, involving the preparation of reports for use in various disputes in both commercial and criminal cases.
Mini Summit 13: Practical Approaches to Handling Investigations Part IV: Roundtable on Best Practices
4:45 pm
Introductions, Panel Discussion and Q&A
Brian Caster, JD
Senior Director, Global Compliance Investigations, APAC Region, Pfizer, Tokyo, Japan
Richard Kershaw
Partner, Financial Advisory, Deloitte, Shanghai, China
Partner, Financial Advisory, Deloitte, Shanghai, China
Richard Kershaw is a partner in Deloitte’s Forensic practice, based in Shanghai. He specializes in technology strategies for complex investigations and disputes, and policy frameworks for information governance and security.
His primary focus is the financial services and life science sectors, and he also has experience assisting technology companies responding to litigation and regulatory enquiries. Prior to joining Deloitte in China, he served as the leader of Deloitte’s Forensic Technology team in Switzerland.
Prior to joining Deloitte, Richard led the forensic technology practice in Asia for a major disputes consultancy. He lived and worked in Japan and China for most of the last two decades, focused on crossborder, multi-language matters.
His primary focus is the financial services and life science sectors, and he also has experience assisting technology companies responding to litigation and regulatory enquiries. Prior to joining Deloitte in China, he served as the leader of Deloitte’s Forensic Technology team in Switzerland.
Prior to joining Deloitte, Richard led the forensic technology practice in Asia for a major disputes consultancy. He lived and worked in Japan and China for most of the last two decades, focused on crossborder, multi-language matters.
Vivian Robinson, Esq.
Partner, McGuireWoods LLP; 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
Partner, McGuireWoods LLP; 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
Vivian Robinson QC became a barrister in 1967 and practiced at the English criminal bar for over forty years, acting for both prosecution and defense. He sat as a part-time judge for over thirty years. He was appointed Queen’s Counsel in 1986, became Head of QEB Hollis Whiteman Chambers and served as Treasurer of Inner Temple.
He left the practicing law to take up appointment as first General Counsel at the Serious Fraud Office. In this capacity he played a prominent role in the development of the SFO’s enforcement strategy on the UK Bribery Act 2010 and was the SFO’s principal liaison with the business community on this subject.
He is a member of McGuireWoods’ Government Investigations & White-Collar Litigation team. He is a co-author of “The FCPA and UK Bribery Act – A Ready Reference for Business and Lawyers”, published by the American Bar Association.
He left the practicing law to take up appointment as first General Counsel at the Serious Fraud Office. In this capacity he played a prominent role in the development of the SFO’s enforcement strategy on the UK Bribery Act 2010 and was the SFO’s principal liaison with the business community on this subject.
He is a member of McGuireWoods’ Government Investigations & White-Collar Litigation team. He is a co-author of “The FCPA and UK Bribery Act – A Ready Reference for Business and Lawyers”, published by the American Bar Association.
Mini vandePol, LLB
Attorney and Chair, Global Compliance and Investigations Group, Baker McKenzie, Hong Kong
Attorney and Chair, Global Compliance and Investigations Group, Baker McKenzie, Hong Kong
Mini vandePol has been a Partner of Baker McKenzie for over 18 years. She was the Chair of the Global Compliance & Investigations Group securing a #4 ranking in the Top 30 Global Investigations Firms with GIR where she was also recognized as one of the “Top 100 Women in Investigations”. She currently leads the Baker Asia Compliance & Investigations Group focusing on compliance program enhancements, transactional compliance risk due diligence / post acquisition integration and internal or regulator led investigations. She has a deep understanding of the challenges faced by Healthcare clients throughout Asia having led significant multi-jurisdictional investigations in China, India, Vietnam and Bangladesh. Mini is the Baker representative on the World Economic Forum’s “Partnership Against Corruption” Initiative, is a member of the B20 Anti-Corruption Taskforce and the VP of the White Collar Women’s Defense Association (HK Chapter).
Bob Pointer
Learning and Development Specialist, Course Design and Delivery Partner, REL Alliance Singapore, Berry Hill, Gloucestershire, UK (Moderator)
Learning and Development Specialist, Course Design and Delivery Partner, REL Alliance Singapore, Berry Hill, Gloucestershire, UK (Moderator)
Bob Pointer is a professional development and education professional specializing in the role and dynamics of humans in business and the link between security and productivity. Bob was a career detective with the City of London Police working primarily in the investigation of serious and organized crime. Following retirement from the Police service he took up a role as a lecturer at City -The University of London and was instrumental in the forming of the Centre for Security, Investigations and Police Sciences. During this time he provided Fraud investigation and prevention seminars on behalf of OLAF (the European Fraud Agency) in Romania, Bulgaria and Croatia. Additionally, he designed and delivered courses for the U.K. Serious Fraud Office, Medicines Agency and the Financial Ombudsman. Since 2011 he was worked as an independent consultant across 5 continents with many multi-national organizations.
5:45 pm
Adjournment
Agenda Links: Precon/Day 1 | Day 3