Agenda Links: Precon/Day 1 | Day 2
AGENDA: DAY III
WEDNESDAY, SEPTEMBER 12, 2018
7:30 am
Registration Commences
DAY III CLOSING PLENARY SESSION
8:30 am
Co-chair Welcome and Introductions
8:45 am
Strategies to Resolve Potential Conflicts of Interest
Ronald Goon
Senior Director, Business Practices and Compliance, Johnson & Johnson; Former Regional Regulatory Manager, Covance Asia- Pacific, Singapore
Senior Director, Business Practices and Compliance, Johnson & Johnson; Former Regional Regulatory Manager, Covance Asia- Pacific, Singapore
Ronald Goon is the Senior Director, Business Practices & Compliance for Johnson. In this capacity, he oversees the company’s Third Party Intermediary due diligence program and chairs the Regional Working Groups in the Asia-Pacific region, supports the healthcare compliance program of the Asia-Pacific Innovation Center, and mergers and acquisition activities in the Asia-Pacific region. He has 30 years of experience in a diverse range of functions in the healthcare industry including sales and marketing, regulatory affairs, clinical research, quality and healthcare compliance.
Kent Kedl, MA
CEO, Greater China and North Asia, Control Risks; Former Vice President and General Manager, Technomic Asia, Shanghai, China
CEO, Greater China and North Asia, Control Risks; Former Vice President and General Manager, Technomic Asia, Shanghai, China
Kent Kedl is a Senior Partner in Control Risks Asia Pacific and CEO for Control Risks’ Greater China and North Asia region. Kent has consulted with multi-national and local Asian corporations across all industries on a diverse range of complex risk and strategy issues; from M&A and organic growth strategy, to crisis management and operational business controls, to strategic and organizational development programs. Kent has particular experience and expertise in the healthcare, food and beverage, manufacturing and consumer products sectors in China and across Asia-Pacific. Prior to joining Control Risks, Kent was general manager and co-owner of Technomic Asia, a market strategy consulting firm providing mergers and acquisitions advice, deal structuring and negotiations, market research and strategy planning. His work included target selection, investigations of companies prior to a deal (acquisitions, joint ventures, licensing, franchising, etc.) and deal negotiations.
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.
Howard Lin
Vice President, Lilly China Ethics & Compliance, Eli Lilly and Company, Singapore
Vice President, Lilly China Ethics & Compliance, Eli Lilly and Company, Singapore
Howard Lin is Vice President of Ethics & Compliance for Eli Lilly and Company (Lilly) in its China affiliate. Mr. Lin began his career in the Life Sciences industry with Lilly in 1999. His work has spanned multiple therapeutic areas (diabetes, bone/muscle/joint, neuroscience, animal health) and multiple geographies (US, China, Asia-Pacific), with the bulk of his experiences in sales and marketing. Since 2010, Mr. Lin has been based in Asia, and has focused primarily on evolving the field of Ethics & Compliance both within Lilly and in the industry.
Yuet Ming Tham, JD
Partner and Global Head of White Collar Group: Government Litigation & Investigations Group and Head of Asia Pacific Compliance and Investigations Group, Sidley Austin, LLP; Singapore, Hong Kong
Partner and Global Head of White Collar Group: Government Litigation & Investigations Group and Head of Asia Pacific Compliance and Investigations Group, Sidley Austin, LLP; Singapore, Hong Kong
Ms. Tham is a partner in the Hong Kong and Singapore offices at Sidley Austin, LLP. She is a global head of the White Collar: Government Litigation & Investigations group and head of the Asia Pacific Compliance and Investigations group. Yuet is also the Chair of the firm’s Asia Pacific Diversity & Inclusion Committee.
Besides compliance and investigations, Yuet focuses on data-security, anti-money laundering regulations and payments. She speaks fluent English, Mandarin, Cantonese and Malay and is admitted in New York, England & Wales, Hong Kong and Singapore.
Prior to joining Sidley, Yuet was the Asia Head of the Regulatory, Compliance & Investigations Group, and Head of the Asia Life Sciences Group at another international law firm. She has also held roles as a Deputy Public Prosecutor in Singapore and was the Asia Pacific Regional Compliance Director for Pfizer.
Besides compliance and investigations, Yuet focuses on data-security, anti-money laundering regulations and payments. She speaks fluent English, Mandarin, Cantonese and Malay and is admitted in New York, England & Wales, Hong Kong and Singapore.
Prior to joining Sidley, Yuet was the Asia Head of the Regulatory, Compliance & Investigations Group, and Head of the Asia Life Sciences Group at another international law firm. She has also held roles as a Deputy Public Prosecutor in Singapore and was the Asia Pacific Regional Compliance Director for Pfizer.
Maija Burtmanis, LLB/BSc LLM
Regional Compliance Director, Japan/Asia Pacific, Shire; Former Healthcare CO, Asia Pacific, Medical Sciences, Johnson & Johnson; Former Associate GC, Alcon Russia; Former Asia Pacific, Country CO, Novartis SG, Singapore (Moderator)
Regional Compliance Director, Japan/Asia Pacific, Shire; Former Healthcare CO, Asia Pacific, Medical Sciences, Johnson & Johnson; Former Associate GC, Alcon Russia; Former Asia Pacific, Country CO, Novartis SG, Singapore (Moderator)
Maija is the Regional Compliance Director, Japan/Asia Pacific for Shire. She was previously the Healthcare Compliance Officer, Asia Pacific Medical Sciences, Johnson & Johnson.
Maija is an Australian qualified lawyer, having a combined LLB/BSC and LLM. Her focus has been on the Life Sciences industry, in which she has held various regional and international roles with both Alcon, Novartis and now Johnson & Johnson in Asia Pacific.
A large part of her work involves providing legal advice and assistance on complex corporate, commercial, BD&L, labor law and compliance matters.
Maija is an Australian qualified lawyer, having a combined LLB/BSC and LLM. Her focus has been on the Life Sciences industry, in which she has held various regional and international roles with both Alcon, Novartis and now Johnson & Johnson in Asia Pacific.
A large part of her work involves providing legal advice and assistance on complex corporate, commercial, BD&L, labor law and compliance matters.
9:45 am
Transition Break
10:00 am
Third Party (Distributor, Vendor, Alliance: Partner, Government-related Associations, HCOs, etc.) Management, including Pre-evaluation, Due Diligence, Contracting, Monitoring and Payment
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.
Hwee Ping Chua, LLM
Associate Vice President, International Legal & Compliance – Asia Pacific, China & Japan, Merck, Former Regional Counsel, Asia Pacific, Bristol-Myers Squibb, Singapore
Associate Vice President, International Legal & Compliance – Asia Pacific, China & Japan, Merck, Former Regional Counsel, Asia Pacific, Bristol-Myers Squibb, Singapore
Hwee Ping Chua is the Associate Vice President, International Legal & Compliance – Asia Pacific, China & Japan for Merck Sharp & Dohme, and heads up the Legal & Compliance function across the region. In her role, Hwee Ping oversees the delivery of legal and compliance support to a broad range of matters, relating to sales and marketing, regulatory, business development, commercial, innovation, labor, and other issues as they arise. Having spent more than 10 years with Merck/MSD and approximately 5 years with Bristol-Myers Squibb, Hwee Ping has acquired extensive experience across various international markets and a good understanding of the legal and regulatory environment in these markets and the accompanying issues and challenges. Before entering the pharmaceutical and healthcare industry as an in-house counsel, Hwee Ping practiced as a litigation lawyer, specializing in corporate and commercial litigation. Hwee Ping is admitted to practice law in Singapore and in the State of New York.
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.
Redentor Romero, JD
Associate Director, Global Third Party Compliance Program, Takeda Pharmaceuticals International; Former Regional Compliance Officer, Teva Pharmaceuticals; Former Regional Legal Counsel, Southeast Asia and Taiwan, AstraZeneca Pharmaceuticals, Singapore
Associate Director, Global Third Party Compliance Program, Takeda Pharmaceuticals International; Former Regional Compliance Officer, Teva Pharmaceuticals; Former Regional Legal Counsel, Southeast Asia and Taiwan, AstraZeneca Pharmaceuticals, Singapore
Redentor Romero is the Associate Director for Global Third Party Compliance in Takeda Pharmaceuticals International, responsible for the Third Party Compliance Program for Takeda globally. Previously, he was the Regional Compliance Officer for Teva Pharmaceuticals covering Asia Pacific. Prior to that, he was the Regional Legal Counsel for AstraZeneca for the Asia Area. He is a lawyer by profession and had practiced law in the Philippines for 10 years, focusing on litigation, contract negotiations and labor law.
Chrisoula Nikidis
Canadian Head of Compliance and Ethics Solutions, IQVIA; Former Executive Director, Ethics and Compliance, Innovative Medicines Canada; Former Industry Co-Chair Desg Group on Ethics, Ottawa, Canada (Moderator)
Canadian Head of Compliance and Ethics Solutions, IQVIA; Former Executive Director, Ethics and Compliance, Innovative Medicines Canada; Former Industry Co-Chair Desg Group on Ethics, Ottawa, Canada (Moderator)
Chrisoula Nikidis is the Canadian Head of Compliance and Ethics Solutions at IQVIA. A dedicated leader in the field of compliance, ethics, governance and stakeholder relations in the innovative medicines and life science sectors, Chrisoula’s successful career is highlighted by creative citizen mobilization, coalition-building and the development of ethical practices on a provincial, national and international level.
She has built a reputation as a trusted and respected leader of issues involving ethics and integrity both in the private and public sectors. She was previously the Executive Director, Ethics and Compliance for Innovative Medicines Canada.
Chrisoula has played a pivotal role in the advancement of compliance and ethics on the provincial, national and international level through her leadership in the Code of Ethical Practices as well as with her work with IFPMA and the APEC Biopharmaceutical Ethics Initiative.
She has built a reputation as a trusted and respected leader of issues involving ethics and integrity both in the private and public sectors. She was previously the Executive Director, Ethics and Compliance for Innovative Medicines Canada.
Chrisoula has played a pivotal role in the advancement of compliance and ethics on the provincial, national and international level through her leadership in the Code of Ethical Practices as well as with her work with IFPMA and the APEC Biopharmaceutical Ethics Initiative.
11:00 am
The Emerging Role of Technology Companies in the Life Science Marketplace and the Ethical and Compliance Implications of this Development
Abhiroop Gandhi, MS, MBA
Trust and Compliance Officer, Verily Life Sciences (an Alphabet company), Former Vice President, Corporate Compliance, Mallinckrodt, San Francisco, CA, USA
Trust and Compliance Officer, Verily Life Sciences (an Alphabet company), Former Vice President, Corporate Compliance, Mallinckrodt, San Francisco, CA, USA
Abhiroop Gandhi is the Trust & Compliance Officer at Verily (formerly Google Life Sciences), a company at the intersection of technology, data science and healthcare. He has over 15 years of experience in biopharmaceuticals and medical devices. He has played roles in corporate compliance, risk management and commercial strategy and operations. He was previously Vice President of Corporate Compliance at Mallinckrodt Pharmaceuticals, where he established the company’s Enterprise Risk Management (ERM) and international healthcare programs. Prior to the acquisition by Mallinckrodt, he helped build and manage Questcor’s healthcare compliance program. Before joining Questcor, Mr. Gandhi held positions at Actelion Pharmaceuticals, Genentech, Razorfish and GE Capital (General Electric).
11:30 am
The Continued Evolution of Compliance as a Profession: Background, Training, Roles and Responsibilities
Dominique Laymand, JD
Executive Vice President, Chief Ethics and Compliance Officer, Ipsen; Honorary President, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Paris, France
Executive Vice President, Chief Ethics and Compliance Officer, Ipsen; Honorary President, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Paris, France
Dominique Laymand is Executive Vice-President, Chief Ethics and Compliance Officer at Ipsen. She leads the Ethics and Compliance team and program, based on a Business Integrity vision. In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb. Dominique Laymand is Honorary President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to be recognized as an independent international association of professionals, which sets standards of Ethics and Compliance, and shapes and influences strategies in the changing Healthcare environment for the ultimate benefit of Patients and Society at large, contributing to the development of Ethics and Compliance professionals. Dominique is an active member of various Pharmaceutical Industry Associations and committees, proactively addressing Trust, Reputation and Compliance and Ethics matters. She also plays a key role in various industry associations and provides ethics and compliance education in many different arenas.
12:00 pm
Co-chairs Closing Comments and Congress Adjournment
Agenda Links: Precon/Day 1 | Day 2