asia pacific pharmaceutical compliance congress
asia pacific pharmaceutical compliance congress
asia pacific pharmaceutical compliance congress
asia pacific pharmaceutical compliance congress
asia pacific pharmaceutical compliance congress
asia pacific pharmaceutical compliance congress



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Preconference / Day 1 | Day 3

       Day II: Asia Pacific Pharma Congress
    Wednesday, September 17, 2014






7:00 a.m.




Registration Commences




    MORNING PLENARY SESSION: COMPLIANCE BEST PRACTICES IN CHINA




8:00 a.m.





Welcome and Overview

Maria "Maru" Quindimil, MBA
Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Manila, Philippines (Co-chair)

    Speaker Bio

    Maru Quindimil is currently the Regional Executive Director Compliance for Asia Pacific (AP) and India for Merck Sharp & Dohme, Asia Ltd. She has worked in the regional compliance role for 5 years in Pharmaceutical, Animal Health and Consumer industries. She has been rotating for the last 9 years in the AP region in diverse compliance and business roles.

    Before her assignment in AP region, she has 19 years of experience on the business side as marketing and sales executive. She has worked at Merck Co Headquarter in New Jersey, USA as Regional Marketing director for Latin America for more than 6 years.

    Her diverse and broad experience in different geographies (US, Europe, Latin America and Asia) has exposed her to different points of views, problem solving as well cultural sensitivity being instrumental for the implementation of an efficient and productive compliance program in the region.

    Maru is currently is monitoring her Asia Pacific team on the implementation of global compliance program as well as a tailored and targeted Asian approach for compliance.

    Prior to joining Merck Sharp & Dohme, Maru was working at Merck KGgA in charge of South America Regional operations.










8:15 a.m.





China's Health System and How it is being Reformed: Implications for Pharmaceutical Manufacturers
  • Overview of the Chinese Health System and Chinese Health Reform
  • The Changing Face of Medical Practice in China
  • The Transformation of the Hospital in China
  • The Role of Pharmacies in China
  • The Structure of the Pharmaceutical Industry in China
  • Roundtable on Strategies for Multinational Pharmaceutical Manufacturer Participation in the Chinese Marketplace
    • Market Access
    • Inherent Compliance Challenges
    • Implications of Health Reform






Damjan P. DeNoble, JD, MA
Partner, Rubicon Strategy Group; Editor, Health Intel Asia, Seattle, WA, USA

    Speaker Bio

    Since 2009 Damjan has been the Managing Editor of Health Intel Asia, a website featuring analysis and strategic considerations of import to healthcare companies in Southeast Asia. In 2012 he became a partner at Rubicon Strategy Group, where his practice focuses on entry services for US healthcare organizations coming into China, and on healthcare consumer research in Vietnam and China.

    Damjan's writing and analysis has appeared in many of the leading China media and health news outlets including the China Business Review, The Health Care Blog, The Atlantic Magazine, Reuters, Thompson Reuters' Bioworld, The Burrill Report and many others.

    He holds three degrees: a B.A. from Duke University in Public Policy, with a certificate in Health Policy, an M.A. in Chinese language and area studies from the Lieberthal-Rogel Center for Chinese Studies at Michigan University, and a J.D. from the University of Michigan Law School.






Sun Qiang
Deputy Dean, Assistant Professor, Center for Health Management and Policy, School of Public Health, Shandong University, Jinan, China

    Speaker Bio

    Sun Qiang is an associate professor in the Center for Health Management and Policy, Shandong University, China, and also is the executive director of the Center for health Management and Policy, the deputy dean of Key Lab of Health Economic and Policy of Ministry of Health in Shandong University. Sun holds a Ph.D. in health economics from Shandong University, and he is also a visiting fellow at Harvard School of Public Health. His research areas include hospital cost accounting, medicine policy and the economic evaluation of chronic infectious diseases control. During the past decades, he has published over 10 research articles in international peer review journals including Health Affairs, International Journal of Tuberculosis and Lung Disease and BMC journals et al.
    Presentation Material (Acrobat)






Benjamin Shobert, MBA
Partner and Founder, Rubicon Strategy Group, Seattle, WA

    Speaker Bio

    Ben is the Managing Director of Seattle-based Rubicon Strategy Group, a boutique consulting firm specialized in market access work in China's healthcare, life science and senior care industries. He is a member of the American Embassy's working group on senior care in China. Rubicon also provides market entry and project management services for healthcare companies across Southeast Asia. In 2013, Rubicon completed the first syndicated research report on Myanmar's healthcare system. Ben is affiliated with the National Bureau of Asian Research (NBR) to advise on aging, healthcare reforms and the pharmaceutical industry in China and Southeast Asia.

    He is a member of the National Committee on US-China Relations and holds advisory board seats at Indiana University's Research Center on Chinese Politics and Business as well as IAHSA-China. In 2012, he became a member of the Pacific Council on International Policy. For six years, he wrote a column for the Asia Times on US-China trade and economic policy matters, with a particular focus on how relations between the two countries are being impacted post the 2008 financial crisis. Ben's work has been featured at CNBC, China Business Review, Fortune Magazine (China), Harvard Asia Quarterly, Yale University's China Hands, and others. He has been a guest on CNBC Asia, CNN, and ABC World News. In late 2012, he began writing at Forbes China and in 2013 began writing on aging and healthcare issues at Forbes.






Chen Yang, Esq.
Partner and Head, China Life Sciences Practice, Sidley Austin LLP; Former Legislative Official, Bureau of Legislative Affairs, Chinese State Council, Beijing, China (Moderator)

    Speaker Bio

    CHEN YANG is a partner in Sidley Austin's Beijing office, where she heads the firm's China Life Sciences practice. Chen's practice focuses on regulatory, corporate and commercial law. She routinely represents international pharmaceutical, medical device and food companies in connection with market entrance, product localization, marketing and promotional activities, product recalls, clinical trials, FCPA/Anti-bribery and other industry-specific regulatory, compliance and enforcement issues, as well as joint ventures, merger and acquisitions, licensing, IP and antitrust matters.

    Chen was given the Life Sciences "All-Star" award by The Asian Lawyer, and the highest ranking in the "China/Hong Kong: Corporate/Commercial" category in PLC's Which Lawyer survey of leading Life Science lawyers worldwide.
    Presentation Material (Acrobat)










9:45 a.m.





"Business Ethics for APEC SMEs" initiative

Maria "Maru" Quindimil, MBA
Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Manila, Philippines

    Speaker Bio

    Maru Quindimil is currently the Regional Executive Director Compliance for Asia Pacific (AP) and India for Merck Sharp & Dohme, Asia Ltd. She has worked in the regional compliance role for 5 years in Pharmaceutical, Animal Health and Consumer industries. She has been rotating for the last 9 years in the AP region in diverse compliance and business roles.

    Before her assignment in AP region, she has 19 years of experience on the business side as marketing and sales executive. She has worked at Merck Co Headquarter in New Jersey, USA as Regional Marketing director for Latin America for more than 6 years.

    Her diverse and broad experience in different geographies (US, Europe, Latin America and Asia) has exposed her to different points of views, problem solving as well cultural sensitivity being instrumental for the implementation of an efficient and productive compliance program in the region.

    Maru is currently is monitoring her Asia Pacific team on the implementation of global compliance program as well as a tailored and targeted Asian approach for compliance.

    Prior to joining Merck Sharp & Dohme, Maru was working at Merck KGgA in charge of South America Regional operations.






Karen Eryou
Senior Director, Corporate Compliance APAC, UCB Pharma, Shanghai, China

Presentation Material (Acrobat)










10:00 a.m.



Break










10:30 a.m.




Overview of Recent Chinese Laws and Regulations: Update and Forward-looking

Chen Yang, Esq.
Partner and Head, China Life Sciences Practice, Sidley Austin LLP; Former Legislative Official, Bureau of Legislative Affairs, Chinese State Council, Beijing, China

    Speaker Bio

    CHEN YANG is a partner in Sidley Austin's Beijing office, where she heads the firm's China Life Sciences practice. Chen's practice focuses on regulatory, corporate and commercial law. She routinely represents international pharmaceutical, medical device and food companies in connection with market entrance, product localization, marketing and promotional activities, product recalls, clinical trials, FCPA/Anti-bribery and other industry-specific regulatory, compliance and enforcement issues, as well as joint ventures, merger and acquisitions, licensing, IP and antitrust matters.

    Chen was given the Life Sciences "All-Star" award by The Asian Lawyer, and the highest ranking in the "China/Hong Kong: Corporate/Commercial" category in PLC's Which Lawyer survey of leading Life Science lawyers worldwide.
    Presentation Material (Acrobat)










11:00 a.m.




Chinese Compliance Best Practices Roundtable

Cheryl Bai, Esq.
Associate General Counsel, Greater China, Allergan Inc., Shanghai, China

    Speaker Bio

    Cheryl Bai is Associate General Counsel of Greater China, Allergan. Her responsibilities cover both compliance and legal for mainland China, Taiwan and Hong Kong. In the last three years, she has been working with Allergan management team to establish compliance program for Allergan Chinese business and has gained extensive knowledge in this area. Before join Allergan, she was junior partner of a Chinese local law firm, which focus on IPO, merger and acquisition and foreign direct investment practice.






Karen Eryou
Senior Director, Corporate Compliance APAC, UCB Pharma, Shanghai, China






Steffanie Lim-Ho
Head of Ethics & Compliance, Lilly China, Shanghai, China

    Speaker Bio

    Steffanie Lim-Ho has been with Eli Lilly & Co. since August 2008. She was recently appointed Vice President of Ethics and Compliance at Lilly China in December 2013. Prior to that she was the Director of Internal Controls, Financial Planning & Analysis, and Pricing at Lilly China for 4 years, and Financial Consultant for early phase molecules supporting Lilly Research Laboratories for 1 year in Indianapolis. Steffanie has 10 years of corporate finance experience with The Boeing Company prior to joining Lilly. She has a bachelor's degree in International Economics from UCLA, and an MBA from The Anderson School at UCLA.






Clarissa SHEN, MBA
Country Compliance Officer, Global Compliance and Business Ethics, Sanofi, Shanghai, China

    Speaker Bio

    Clarissa Shen is Country Compliance Head, responsible for designing an effective Compliance Program for Sanofi China to uphold Sanofi Group's highest ethical standards.

    Clarissa has extensive business management experiences in the area of credit management, supply chain management; and distributorship and agent management with world's leading Pharmaceutical and Chemical companies. Since year 2009, Clarissa has progressed her career, having acted as acting compliance head for Bristol-Myers Squib (China) and associate compliance director for Eli Lilly Asia.

    Clarissa graduated from Shanghai University with a bachelor degree and obtained an UK accredited MBA degree from University of Canterbury, Christchurch New Zealand.






Shine Yao, MIM
Compliance Director, Merck, Shanghai, China






Emmanuel Vignal
Partner, Fraud Investigation & Dispute Services, EY, Shanghai, China (Moderator)

    Speaker Bio

    Emmanuel is the Leader of EY's Fraud Investigation & Dispute Services in Greater China.

    He has nearly 20 years of experience in forensic accounting, anti-bribery/anti-corruption reviews, transactions forensics and litigation support, including over 16 years in Hong Kong and Shanghai.

    In the pharmaceutical and medical devices sectors, Emmanuel has carried out numerous enquiries involving suspected improper payments to HCPs and KOLs through expense schemes, third party intermediaries or vendors. He is also routinely involved in risk and compliance assessments at the Chinese operations of MNCs as well as in Foreign Corrupt Practices Act (FCPA) due diligence.










12:15 p.m.



Networking Luncheon




    DAY II: AFTERNOON MINI SUMMITS BLOCK A




MINI SUMMIT I:



TRAINING ON COMPLIANCE AND ETHICS BASICS -- PROGRAM BASICS
  • The Basics of a Compliance Program: The Global Standard for Effective Programs
  • The Role of Values Based Ethics in a Compliance Program
  • The Role of Governance, Decision Making and Escalation
  • The Roles and Responsibilities of the Compliance Officer



1:15 p.m.



Introductions, Panel Discussion and Q&A

Cristopher Landrito, LIB
Regional Compliance Officer, APAC Group Compliance, Merck Pte. Ltd., Singapore




Abdul Luheshi, MBA
Vice President, Health Care Compliance, Johnson & Johnson; Former Co-chair, Asia Pacific Pharma Congress, London, UK

    Speaker Bio

    VP, Health Care Compliance & Privacy

    14 years with Johnson & Johnson of which 5 years as Head of Compliance for LifeScan EMEA and 4 years leading the health care compliance team for Janssen Pharmaceuticals in Asia. Currently based between the UK and China overseeing program enhancement initiatives for Johnson & Johnson.

    Originally an organic chemist, post-MBA has held posts in operations management and finance across the chemical, agrichemical and healthcare industries.



Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC, USA (Moderator)

    Speaker Bio

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



2:45 p.m.


Transition Break












MINI SUMMIT II:




HOT ASIA PAC COMPLIANCE ISSUES


1:15 p.m.


Advanced Issues in Global Transparency: Data Disclosure and Aggregate Spend Management

Dario Ghoddousi
Senior Vice President of Global Transparency and Master Data Management Solutions, Cegedim Relationship Management, Paris, France

    Speaker Bio

    Dario Ghoddousi, Senior Vice President of Global Transparency and Master Data Management Solutions, has been with Cegedim since 1993. He has contributed to the growth and development of the company by successfully executing a variety of key roles with increasing responsibilities. These roles include General Manager, Vice President Marketing, Director of Sales and Vice President Global Business Development. Mr. GHODDOUSI is now fully focused on driving the Cegedim resources on Transparency and creating a Business Unit that is delivering best in class solutions to customers around the globe.
    Presentation Material (Acrobat)



Timothy Ayers, JD, MPH
Principal, Porzio, Bromberg & Newman; Former Vice President, Chief Compliance Officer, Dendreon Corporation; Former Associate General Counsel, Executive Director of Compliance, Seattle Genetics, Morristown, NJ, US (Moderator)

    Speaker Bio

    Timothy S. Ayers is a vice president of Porzio Life Sciences. As a former in-house counsel and leader in compliance, Timothy is experienced in the practicalities of the life sciences industry. He is intimately familiar with the challenges and best practices associated with establishing, maintaining and building life science compliance programs.

    He applies his insight and experience to develop and deliver innovative and practical solutions to our pharmaceutical, medical device and biotechnology customers. Moreover, Timothy oversees PorzioLS personnel, quality assurance and marketing efforts. In addition to these responsibilities, he is also a principal of Porzio, Bromberg & Newman in the Life Sciences Compliance and Commercialization Department. With a background as in-house counsel in the pharmaceutical/healthcare industry, he is familiar with the business challenges faced by members of corporate legal and compliance departments and counsels them on a wide variety of compliance-related issues.

    As Vice President, Chief Compliance Officer for Dendreon Corporation from January 2012 through June 2013, Timothy created, developed and implemented a company-wide compliance program in the United States and in Europe. Prior to that, he served as Associate General Counsel for pharmaceutical, biotech and other life sciences companies where he established and implemented compliance programs, and provided legal counsel in the areas of commercialization, research and development, global issues and corporate issues.
    Presentation Material (Acrobat)



2:15 p.m.



Cross Border Engagement of Healthcare Professionals

Steven N. Gersten, Esq.
Vice President, Ethics and Compliance Officer, International and Global Marketing, AbbVie; Former Divisional Vice President and Associate General Counsel, Commercial Legal Operations, Abbott Laboratories, Chicago, IL, USA

    Speaker Bio

    Steven N. Gersten is Vice President and Ethics & Compliance Officer, International at AbbVie. In this capacity, he supports certain headquarters based functions and the international business operations. Prior to assuming this role in January 2013, Steve was Chief Regulatory & Compliance Counsel and later Chief Commercial Counsel, Nutrition and Diagnostics, at Abbott. Steve also has worked at the U.S. DOJ where he prosecuted criminal and civil violations of the U.S. Food, Drug & Cosmetic Act and other federal statutes, and as a litigation attorney at two law firms.
    Presentation Material (Acrobat)



2:45 p.m.



Transition Break












MINI SUMMIT III:



COUNTRY COMPLIANCE UPDATES: MALAYSIA AND INDOCHINA, INCLUDING CAMBODIA, LAOS, THAILAND AND VIETNAM



1:15 p.m.



Introductions, Panel Discussion and Q&A

Kitchrat Kontain, LLM, MBA
Managing Partner, South East Asia Law Office, Baker & McKenzie, Vientiane, Laos




Bretton G. Sciaroni, Esq.
Partner, Sciaroni & Associates, Phnom Penh, Cambodia

    Speaker Bio

    Brett has been a lawyer and investment adviser in Phnom Penh since 1993, making him one of the first foreign lawyers in Cambodia in the modern era and focuses principally on commercial law.

    In 1996, Mr. Sciaroni was named Legal Adviser to the Royal Government in a decree signed by King Norodom Sihanouk. He was reappointed to this position by Royal Decree in successive governments in 1999, 2004, 2008 and 2013. The position carries with it the rank of minister.

    Mr. Sciaroni also has served in a number of positions in the business community as the Chairman of AMCHAM and the International Business Chamber and serves on the Boards of Directors of a number of entities, including banks, commercial enterprises and non-governmental institutions.

    Mr. Sciaroni has served in the U.S. Government, including positions at the White House and in the International Trade Administration at the U.S. Department of Commerce.



Yee Chung Seck, Esq.
Partner, Baker & McKenzie (Vietnam) Ltd. Ho Chi Minh City, Socialist Republic of Vietnam

    Speaker Bio

    Yee Chung Seck leads the Firm's Mergers & Acquisitions and Pharmaceuticals & Healthcare Practice in Vietnam. Chambers Global, Chambers Asia and IFLR1000 rank him as a leading lawyer in the field of Corporate/M&A.

    Highly regarded in his field, Mr. Seck has been involved in various regulatory and corporate matters specific to the pharmaceutical and healthcare industry. He is known to deliver sound advice on corporate and regulatory compliance matters, particularly on foreign direct investment, market access under the WTO, competition and anti-corruption compliance, over a diverse range of industries, from pharmaceuticals, cosmetics, and food & beverage, to manufacturing and IT/C.



Yuthana Sivaraks
Partner, Baker & McKenzie Ltd., Bangkok, Thailand

    Speaker Bio

    Yuthana Sivaraks joined Baker & McKenzie in 1995 and is currently a partner. He is primarily active in the Corporate & Commercial, IT/Communications, and Intellectual Property practice groups. He assists clients with administrative law matters including government procurement regulations, and advises on challenging decisions made by government authorities. He counsels on trade competition and compulsory licensing, and is an acknowledged leader in the field of telecommunications law. He also represents clients in arbitration proceedings in disputes arising from international sale contracts, and in the Supreme Court's Criminal Division for Persons Holding Political Positions relating to government contracts and procurement.



Kherk Ying Chew, Esq.
Managing Partner, Wong & Partners, An affiliate of Baker & McKenzie, Kuala Lumpur, Malaysia (Moderator)

    Speaker Bio

    CHEW KHERK YING is a Partner at Wong & Partners and heads the Intellectual Property (IP) and Dispute Resolution practice groups, handling a wide range of IP matters with regard to copyright, patent, trade and service marks, registered designs, trade secrets and confidential information. She also advises clients on labelling and advertising regulations on permissible practices under codes by the Pharmaceutical Association of Malaysia (PhAMA).

    Kherk Ying is ranked in the first tier of IP practitioners by Chambers Asia and Asia Pacific Legal 500 and was named among Asia's "50 IP Litigators You Should Know" by Asia IP, 2013.

    She is the principal author of the CCH published "Intellectual Property Laws of Malaysia"
    Presentation Material (Acrobat)



2:45 p.m.



Transition Break












MINI SUMMIT IV:



BUILDING THE COMPLIANCE PROFESSION



1:15 p.m.



Compliance -- A Journey Beyond the Rules

Teng Ren, MA
Head of Compliance, Asia-Pacific, Middle East and Africa, Russia/Ukraine, Novartis; Former Compliance Director, Johnson & Johnson Medical China and Eli Lilly, Singapore




Masood Ahmed
Vice President, Regional Compliance Officer Asia & JPAC, Sanofi Group, Singapore (Moderator)

    Speaker Bio

    Masood Ahmed is the Vice President and Regional Compliance Officer, Asia & JPAC of Sanofi Group.

    Masood started his career as finance professional with Beecham. He had held positions of CFO in Upjohn, Pharmacia, GSK & vice President Operations Pfizer before embarking on his role as Regional Compliance Officer with Schering-Plough.

    Masood had significantly contributed in several merger and integration activities of giant pharmaceutical organizations which provided him unique opportunities of managing people, strategies and processes integration and shaping the corporate culture.

    Masood has been intimately involved in the evolution of Pharmaceuticals industry's compliance environment in challenging markets in Asia.
    Presentation Material (Acrobat)



1:45 p.m.



Strategies for Compliance Talent Development

Karen Eryou
Senior Director, Corporate Compliance APAC, UCB Pharma, Shanghai, China (Moderator)



2:15 p.m.



Post-merger Consolidation of Compliance Programs

Michelle Y.L. Gon, Esq.
Partner, Baker & McKenzie, Shanghai

    Speaker Bio

    Michelle Gon is a Senior Partner at the Baker & McKenzie Shanghai Office. Ms. Gon has years of experience in a wide spectrum of practices in China and internationally. Her practice primarily covers regulatory and compliance from the perspectives of anti-bribery law, the Foreign Corrupt Practices Act (FCPA), anti-unfair competition law and anti-monopoly law areas focusing on distribution and trade practice.

    Ms. Gon was selected as one of the top 30 attorneys in China and one of the top 100 attorneys in the Asia Pacific region by Asian Legal Business. She was also listed by Chambers Asia Pacific as a leading lawyer in life sciences in China. Ms. Gon is admitted to practice law in the State of Illinois.



Andrew Martin, Esq.
Principal, Baker & McKenzie, Wong & Leow, Singapore

    Speaker Bio

    Andrew Martin has spoken extensively on cross-border M&A with particular reference to SE Asia. Highly recommended by PLC Which lawyer? Mr. Martin is the head of the Singapore Corporate & Securities Group. He serves as a member of the Firm's Global Compliance Steering Committee, India Focus Group and Asia Pacific Regional M&A Steering Committee.

    Mr. Martin is a corporate and commercial lawyer with a particular focus on cross-border M&A and joint ventures. His practice also covers a diverse array of commercial contracts and all aspects of corporate counselling with special reference to corporate compliance and governance. He advises both multinational companies and private equity houses from Asia, US and Europe.



Maria "Maru" Quindimil, MBA
Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Manila, Philippines

    Speaker Bio

    Maru Quindimil is currently the Regional Executive Director Compliance for Asia Pacific (AP) and India for Merck Sharp & Dohme, Asia Ltd. She has worked in the regional compliance role for 5 years in Pharmaceutical, Animal Health and Consumer industries. She has been rotating for the last 9 years in the AP region in diverse compliance and business roles.

    Before her assignment in AP region, she has 19 years of experience on the business side as marketing and sales executive. She has worked at Merck Co Headquarter in New Jersey, USA as Regional Marketing director for Latin America for more than 6 years.

    Her diverse and broad experience in different geographies (US, Europe, Latin America and Asia) has exposed her to different points of views, problem solving as well cultural sensitivity being instrumental for the implementation of an efficient and productive compliance program in the region.

    Maru is currently is monitoring her Asia Pacific team on the implementation of global compliance program as well as a tailored and targeted Asian approach for compliance.

    Prior to joining Merck Sharp & Dohme, Maru was working at Merck KGgA in charge of South America Regional operations.



Gareth Lee, Esq.
General Counsel and Head of Compliance, Asia Pacific, Allergan Inc., Singapore (Moderator)

    Speaker Bio

    Gareth is General Counsel, Asia Pacific of Allergan INC. In this role, he heads Allergan's regional legal & compliance functions and provides leadership in growing & developing high performing legal & compliance teams in markets around the Asia Pacific.

    Gareth is a senior legal professional with 20 years experience. He started his legal career as a solicitor in the corporate & commercial practice with a leading Singapore law firm and thereafter as legal counsel with increasing responsibilities in companies such as Royal Dutch Shell & Halliburton. He has been in legal leadership positions in the pharmaceutical and medical devices industry for the past 9 years, initially with Baxter Healthcare and now with Allergan.



2:45 p.m.



Transition Break












MINI SUMMIT V:



ADVANCED ISSUES IN ANTICORRUPTION COMPLIANCE



1:15 p.m.



Introductions, Panel Discussion and Q&A

Carole Ducrest, Esq.
Regional General Counsel, APAC, China, Japan, Merck KGaA, Singapore

    Speaker Bio

    Carole Ducrest is Regional General Counsel, APAC, China, Japan of Merck Serono where she is responsible for managing the organization's legal affairs in Asia. She is also a member of the Regional Management Team.

    Ms. Ducrest holds a Masters in Law from the Geneva University. She spent the first 2 years of her legal career at the Geneva office of the local law firm Ducret, Ducrest, Van Loon and Associates. She was a junior lawyer in the litigation team and represented private clients in real-estate, commercial disputes, debt-recovery as well as family affairs. She was also listed on the State sponsored pro-bono criminal lawyers list and defended several cases of drug dealing and aggravated assault.

    Ms. Ducrest is based in Singapore.



Hwa-Soo Chung, Esq.
Chair, Health Law Group, Kim & Chang Law Firm, Seoul, South Korea

    Speaker Bio

    Hwa Soo Chung is a foreign attorney who serves as the chair of Kim & Changs Health Practice Group. She is also a member of the Mergers & Acquisitions Practice Group and Corporate Governance Practice Group.

    As chair of the firm's health practice, Ms. Chung represents a broad range of companies in the pharmaceutical/medical device/food/cosmetic sectors, advising on corporate, regulatory, compliance, and general commercial law issues. Ms. Chung is expert on 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.



Lei Li, LLB, LLM
Partner, Sidley Austin LLP, Beijing, China

    Speaker Bio

    Lei Li is a partner in Sidley Austin's Beijing office, focusing on antitrust, FCPA compliance, commercial litigation (including trade litigation) matters.

    Mr. Li provides merger clearance advice in high-profile domestic and cross-border M&A deals and inbound joint venture transactions. Mr. Li is featured as a leading antitrust lawyer by Chambers Asia Pacific, IFLR 1000, and China Business Law Journal.

    Mr. Li advises multinational companies and their Chinese subsidiaries on all types of investigation and compliance matters under the U.S. Foreign Corrupt Practices Act (FCPA), as well as China's anti-bribery laws.

    Mr. Li advises clients on cross-border complex commercial litigation matters and represents Chinese companies in Section 337 investigations before the United States International Trade Commission (ITC).



John Tan, Esq.
Counsel, Reed Smith, Former China Regional Compliance Director, Pfizer, Shanghai, China




Bing Yu, LLB, LLM
Of Counsel, Clifford Chance LLP, Shanghai, China




Lars Eckerlein
Partner, Fraud Investigation & Dispute Services, EY, Beijing, China (Moderator)

    Speaker Bio

    Lars is a Partner in EY's Fraud Investigation & Dispute Services. He has more than 20 years of experience with EY in US, Germany, and China. For the past 10 years, Lars has been based in Beijing, China. Lars also assumes the role of Chair of the Finance & Taxation working group at the European Chamber of Commerce in Beijing.

    As one of the leading global professional services organizations, EY has extensive experience in China in advising its clients related to fraud investigations, anti-fraud, corporate compliance, anti-bribery, anti-corruption etc., with a particular focus on the Life Sciences industry.
    Presentation Material (Acrobat)



2:45 p.m.



Transition Break












    DAY II: AFTERNOON MINI SUMMITS BLOCK B




MINI SUMMIT VI:




TRAINING ON COMPLIANCE AND ETHICS BASICS -- ADDRESSING CORE COMPLIANCE RISKS
  • The Basics of Anti-Corruption
  • The Basics of Disclosure/Transparency
  • The Basics of Pricing, Reimbursement Tendering and Public Procurement
  • The Basics of Data Protection


3:00 p.m.


Introductions, Panel Discussion and Q&A

Cristopher Landrito, LIB
Regional Compliance Officer, APAC Group Compliance, Merck Pte. Ltd., Singapore




Abdul Luheshi, MBA
Vice President, Health Care Compliance, Johnson & Johnson; Former Co-chair, Asia Pacific Pharma Congress, London, UK

    Speaker Bio

    VP, Health Care Compliance & Privacy

    14 years with Johnson & Johnson of which 5 years as Head of Compliance for LifeScan EMEA and 4 years leading the health care compliance team for Janssen Pharmaceuticals in Asia. Currently based between the UK and China overseeing program enhancement initiatives for Johnson & Johnson.

    Originally an organic chemist, post-MBA has held posts in operations management and finance across the chemical, agrichemical and healthcare industries.



Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC, USA (Moderator)

    Speaker Bio

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



4:30 p.m.


Transition Break












MINI SUMMIT VII:




COUNTRY COMPLIANCE UPDATES


3:00 p.m.


Myanmar

James Finch, Esq.
Partner and Head of Myanmar Office, DFDL/Myanmar Thanlwin Legal Services Ltd., Yangon, Myanmar

    Speaker Bio

    James Finch is a partner in the law firm of DFDL and runs the firm's practice in Myanmar. His experience in the commercial legal field spans three decades and has taken him to the Middle East, Latin America and the Caribbean, where he practiced for extended periods. His work as a partner in the firm of Russin & Vecchi finally brought him to Asia, where he began in the Hanoi office of the firm. In 1996 he became managing partner of the firm's Yangon, Myanmar office. Since then he has had a varied and active practice in Myanmar, with extensive legal work in the energy, power, hard minerals, corporate, tax, aircraft leasing, hotel development, banking and finance fields, to name a few. DFDL, the firm for which he is a partner in Myanmar was chosen as IFLR's Myanmar law firm of the year for 2013 and 2014. He recently opened an office in Naypyidaw and was designated as a leading lawyer by Asia Law for 2014. He was named to the Legal Who's Who for both project finance and energy for 2014.
    Presentation Material (Acrobat)


3:30 p.m.


India

Sanjay Dhawan
Pharma GRC Leader; Executive Director, Risk Advisory Services, PwC, Bangalore, India

    Speaker Bio

    Sanjay Dhawan is Pharma GRC Leader and Senior Partner with the Risk Advisory Services of PwC, India. Sanjay is a fellow member of the Institute of Chartered Accountants of India (ICAI) and also holds CISA and CISM qualification from ISACA, USA. During his 30 plus years of professional working experience, Sanjay has worked across different geographies including Middle East, Europe and India. In his role as Pharma GRC Leader, Sanjay works closely with CXO suite of leading multi-national and domestic Pharma companies to help establish good corporate governance framework for addressing strategic, operational, financial and business risks. Sanjay helps them enhance compliance levels, develop risk management framework, establish control self-assessment framework and other assurance and business advisory services.
    Presentation Material (Acrobat)


4:00 p.m.


Indonesia

Cahyani Endahayu
Associate Partner, Hadiputranto, Hadinoto & Partners, An affiliate of Baker & McKenzie, Jakarta, Indonesia

    Speaker Bio

    Cahyani Endahayu is an Associate Partner in the Corporate/Commercial Practice Group. She joined the firm in 2000 and has 14 years of experience advising clients in corporate/ commercial issues. She handles the corporate/licensing and day-to-day work of several of the Firm's major clients and provides corporate and advisory support services to other clients in relation to corporate/commercial issues. While doing general corporate/commercial matters, her focus areas are pharmaceutical, beauty (cosmetics) and healthcare, retail and foreign investment sectors.

    Ms. Endahayu's experience includes providing advisory support services on corporate and foreign investment matters, as well as assist various pharmaceutical manufacturing companies in reviewing and providing advise on legal matters.
    Presentation Material (Acrobat)



4:30 p.m.



Transition Break












MINI SUMMIT VIII:




INVESTIGATIONS UPDATES


3:00 p.m.


Responding to Government Investigations/Dawn Raids

Dane Chamorro
Managing Director, Control Risks Southeast Asia, Singapore

    Speaker Bio

    Dane Chamorro has 25 years' experience in the Asia region with private sector and US government postings. Prior to his current role running the South-east Asia region, Dane was Managing Director of the company's North Asia territory encompassing Greater China, Korea and Mongolia (2007-11), where he successfully launched Control Risks' Shanghai, Hong Kong and Beijing offices. Dane is a Certified Fraud Examiner and a licensed investigator in Singapore who regularly advises clients on political and partner risks, corporate governance and high-profile business disputes. He is an honors graduate of Georgetown University's School of Foreign Service and a fluent Mandarin speaker.



Eugene Chen, Esq.
Partner, Shanghai Office, Hogan Lovells International LLP, Shanghai, China

    Speaker Bio

    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 six 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.



Iona Cheng
Practice Leader, Integrity Risk Consulting, Greater China and North Asia, Shanghai, China

    Speaker Bio

    Iona is the Practice Leader for Control Risks' Integrity Risk Consulting practice for the Greater China region. She is responsible for advising clients on integrity risks and developing anti-bribery and anti-corruption solutions. She has extensive experience working with multinational clients in healthcare, manufacturing, financial services and FMCG sectors. She works closely with Control Risks' teams of forensic reviewers, political risk analysts and crisis management experts to help clients proactively reduce their exposure to corruption in order to build sustainable and ethical businesses. Her expertise and experience include conducting integrity risk assessment, advising on third-party management, developing effective compliance programmes and conducting anti-corruption training.



Myung Soon Chung
Foreign Attorney, Health Practice Group, Kim & Chang, Seoul, Korea





Yunjoh Lee
Attorney, Health Practice Group, Kim & Chang, Seoul, Korea





Hwa-Soo Chung, Esq.
Chair, Health Law Group, Kim & Chang Law Firm, Seoul, South Korea (Moderator)

    Speaker Bio

    Hwa Soo Chung is a foreign attorney who serves as the chair of Kim & Changs Health Practice Group. She is also a member of the Mergers & Acquisitions Practice Group and Corporate Governance Practice Group.

    As chair of the firm's health practice, Ms. Chung represents a broad range of companies in the pharmaceutical/medical device/food/cosmetic sectors, advising on corporate, regulatory, compliance, and general commercial law issues. Ms. Chung is expert on 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.




3:45 p.m.


The Interplay between Anti-Monopoly and Anti-bribery Investigations

Adrian Emch, LLM
Partner, Hogan Lovells International LLP, Beijing, China

    Speaker Bio

    Adrian Emch practises antitrust law. He has broad experience in all aspects of competition law, including merger control, multi-jurisdictional merger filings, cartel investigations and antitrust counseling.

    Adrian is a lecturer of competition law and member of the faculty at Peking University's Law School.

    Prior to joining Hogan Lovells, Adrian completed an internship with the Directorate-General of Competition at the European Commission (DG COMP) and was in private practice in Brussels and Beijing in the field of competition law.



Eugene Chen, Esq.
Partner, Hogan Lovells International LLP, Shanghai, China (Moderator)

    Speaker Bio

    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 six 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.



4:30 p.m.



Transition Break












MINI SUMMIT IX:



PUBLIC PROCUREMENT, TENDERING, REIMBURSEMENT AND PHARMA PRICING UPDATE



3:00 p.m.



Introductions, Panel Discussion and Q&A

Ren Jun Lim
Partner, Baker & Mckenzie, Singapore

    Speaker Bio

    Ren Jun represents local and international intellectual property-intensive clients in both contentious and non-contentious matters.

    These matters include civil and criminal litigation for copyright and trade mark infringement; local and cross-border filing and prosecution strategies in respect of patents, trade marks, plant varieties and registered designs; domain name protection and dispute resolution; trade mark opposition matters; product / company defamation issues as well as anti-corruption / anti-money laundering issues. They also include commerical issues like licensing, franchising, data protection and M&A due diligence.

    Ren Jun also plans and executes anti-counterfeiting operations for various clients in Singapore and around the Asia Pacific region.

    Ren Jun keenly advises on a wide range of issues relating to the pharmaceutical and healthcare industries. These include a full range of regulatory compliance in respect of drugs, medical devices, clinical trials, health supplements and cosmetics; product liability and recall issues; government tenders and anti-corruption / US Foreign Corrupt Practices Act issues.
    Presentation Material (Acrobat)



Clement Ngai, Esq.
Partner, Baker & McKenzie Shanghai Office, Shanghai, China

    Speaker Bio

    Mr. Ngai is a partner of Baker & McKenzie's Shanghai office. His practice focuses on pharmaceutical/regulatory and technology transactions in China. He is technically trained and obtained a Masters in Biochemistry before becoming a lawyer. He was listed by Chambers Asia Pacific as a leading lawyer in life sciences in China.

    Mr. Ngai graduated with a PCLL from University of Hong Kong, an LLB from University of London, M.Phil (Biochemistry) from Chinese University of Hong Kong and B.Sc (Biology) from University of Hong Kong. Mr. Ngai is admitted to practice as a lawyer in Hong Kong. He speaks English, Mandarin and Cantonese.
    Presentation Material (Acrobat)



Richard Yun
Partner, King & Wood Malleson, Beijing, China

    Speaker Bio

    Mr. Richard Yun specializes in litigation, arbitration and alternative dispute resolution as well as compliance.

    As a key member of King & Wood Mallesons' Compliance Group, he has extensive experience in the fields of compliance, corporate governance and risk management. Mr. Yun often provides compliance advice to clients on a variety matters in relation to antitrust, competition, commercial bribery and Customs. Mr. Yun also assists a number of multinational companies in drafting and enforcing compliance manuals and code of ethics and standards, dealing with external investigations initiated by the competent regulatory and enforcement agencies against those companies and conducting internal investigations.

    Mr. Yun joined King & Wood Mallesons in 1999. Mr. Yun had been working for several world-renowned large-scale multinational companies as senior legal counsel and legal director from 2002 to 2008. Mr. Yun rejoined the firm in 2010. Prior to this, he took the role of Legal Director, Asia Pacific Region in a well- known US based multinational company.
    Presentation Material (Acrobat)



4:30 p.m.



Transition Break












MINI SUMMIT X:




THE ROLE OF FORENSICS IN COMPLIANCE


3:00 p.m.

Strengthen Compliance Through Leveraging Dynamic Analytics
  • Compliance Framework
  • Know Your Third Party Social network analysis
  • Sanctions analytics
  • Compliance Continuous Monitoring
Chi Chen
EY Associate Director FTDS, FIDS, Shanghai, China





Julie Tan
Sr. Compliance Manager, Shanghai, China





Shine Yao
VP, MSD China Holding Compliance, Shanghai, China





Eric Young
Forensic Technology Partner, EY, Hong Kong

    Speaker Bio

    Eric joined Ernst & Young in May 2014 as the Greater China Leader of our Forensic Technology & Discovery Services (FTDS) practice.

    He started his career at a Software Technology company based in US working mostly on ERP, Data warehouse, BI, mobile and web development initiatives before joining a credit management service firm and investment bank in China, Taiwan and Hong Kong.

    Eric has 19 years of Technology and operations experience incorporating extensive Data Analytics business development in Greater China focusing on credit risk Management solutions.





Marx Zhou
Baxter (china Investment Co., Ltd), Sr. Compliance Manager/ Asia Pacific, Shanghai, China



3:45 p.m.


The Role of Forensics in Compliance
  • Lessons Learned from Compliance Investigations
  • Tools for Identifying High Risk Transactions
  • Leveraging Data Analytics
  • Developing Effective Monitoring Programs
Ramesh Moosa
Partner, Forensic Technology Solutions, PwC, Shanghai, China

    Speaker Bio

    Ramesh is a partner in the PwC Forensic Services practice in China and Hong Kong. He also leads the Forensic Technology Solutions (FTS) team in the greater China region. Ramesh, a former law enforcement officer, has worked at PwC in Hong Kong, US and Singapore to provide Fraud Investigations, Forensic Technology, Cyber Crime Investigation and Cyber Security Services. As an experienced investigator who is also adept with technology, Ramesh leverages forensic data analytics extensively in the conduct of investigations and sees an increasing trend in the use of analytics as a critical component of a robust compliance monitoring program.



4:30 p.m.



Transition Break












    DAY II: AFTERNOON MINI SUMMITS BLOCK C




MINI SUMMIT XI:




TRAINING ON COMPLIANCE AND ETHICS BASICS -- EVOLVING ISSUES, RISING EXPECTATIONS
  • Conducting Effective Third-Party Due Diligence
  • Developing Effective Commercial/Medical Boundaries in Interactions with HCPS
  • The Role of Analytics in Monitoring and Program Oversight
  • Building Effective Relationships with the Business


4:45 p.m.

Introductions, Panel Discussion and Q&A

Cristopher Landrito, LIB
Regional Compliance Officer, APAC Group Compliance, Merck Pte. Ltd., Singapore




Abdul Luheshi, MBA
Vice President, Health Care Compliance, Johnson & Johnson; Former Co-chair, Asia Pacific Pharma Congress, London, UK

    Speaker Bio

    VP, Health Care Compliance & Privacy

    14 years with Johnson & Johnson of which 5 years as Head of Compliance for LifeScan EMEA and 4 years leading the health care compliance team for Janssen Pharmaceuticals in Asia. Currently based between the UK and China overseeing program enhancement initiatives for Johnson & Johnson.

    Originally an organic chemist, post-MBA has held posts in operations management and finance across the chemical, agrichemical and healthcare industries.



Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC, USA (Moderator)

    Speaker Bio

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



6:15 p.m.


Adjournment












MINI SUMMIT XII:




COMPLIANCE BEST PRACTICES


4:45 p.m.

Auditing Distributors for a Small or Mid-sized Company
  • What Issues are more Important to Audit
  • Who Participates (GxP Issues or just Fraud)
  • How many Layers do you Audit
Timothy Ayers, JD, MPH
Principal, Porzio, Bromberg & Newman; Former Vice President, Chief Compliance Officer, Dendreon Corporation; Former Associate General Counsel, Executive Director of Compliance, Seattle Genetics, Morristown, NJ, USA

    Speaker Bio

    Timothy S. Ayers is a vice president of Porzio Life Sciences. As a former in-house counsel and leader in compliance, Timothy is experienced in the practicalities of the life sciences industry. He is intimately familiar with the challenges and best practices associated with establishing, maintaining and building life science compliance programs.

    He applies his insight and experience to develop and deliver innovative and practical solutions to our pharmaceutical, medical device and biotechnology customers. Moreover, Timothy oversees PorzioLS personnel, quality assurance and marketing efforts. In addition to these responsibilities, he is also a principal of Porzio, Bromberg & Newman in the Life Sciences Compliance and Commercialization Department. With a background as in-house counsel in the pharmaceutical/healthcare industry, he is familiar with the business challenges faced by members of corporate legal and compliance departments and counsels them on a wide variety of compliance-related issues.

    As Vice President, Chief Compliance Officer for Dendreon Corporation from January 2012 through June 2013, Timothy created, developed and implemented a company-wide compliance program in the United States and in Europe. Prior to that, he served as Associate General Counsel for pharmaceutical, biotech and other life sciences companies where he established and implemented compliance programs, and provided legal counsel in the areas of commercialization, research and development, global issues and corporate issues.
    Presentation Material (Acrobat)



5:30 p.m.



Roundtable on Best Practices in Implementing the 7 Elements of an Effective Compliance Program: Real Life, Practical Approaches

Masood Ahmed
Vice President, Regional Compliance Officer Asia & JPAC, Sanofi Group, Singapore

    Speaker Bio

    Masood Ahmed is the Vice President and Regional Compliance Officer, Asia & JPAC of Sanofi Group.

    Masood started his career as finance professional with Beecham. He had held positions of CFO in Upjohn, Pharmacia, GSK & vice President Operations Pfizer before embarking on his role as Regional Compliance Officer with Schering-Plough.

    Masood had significantly contributed in several merger and integration activities of giant pharmaceutical organizations which provided him unique opportunities of managing people, strategies and processes integration and shaping the corporate culture.

    Masood has been intimately involved in the evolution of Pharmaceuticals industry's compliance environment in challenging markets in Asia.
    Presentation Material (Acrobat)



Steffanie Lim-Ho
Head of Ethics & Compliance, Lilly China, Shanghai, China

    Speaker Bio

    Steffanie Lim-Ho has been with Eli Lilly & Co. since August 2008. She was recently appointed Vice President of Ethics and Compliance at Lilly China in December 2013. Prior to that she was the Director of Internal Controls, Financial Planning & Analysis, and Pricing at Lilly China for 4 years, and Financial Consultant for early phase molecules supporting Lilly Research Laboratories for 1 year in Indianapolis. Steffanie has 10 years of corporate finance experience with The Boeing Company prior to joining Lilly. She has a bachelor's degree in International Economics from UCLA, and an MBA from The Anderson School at UCLA.



Rhys Tee
Associate Director, Compliance (APAC), Allergan, Singapore




6:15 p.m.



Adjournment












MINI SUMMIT XIII:




COUNTRY COMPLIANCE UPDATES


4:45 p.m.

Korea
Hwa-Soo Chung, Esq.
Chair, Health Law Group, Kim & Chang Law Firm, Seoul, South Korea

    Speaker Bio

    Hwa Soo Chung is a foreign attorney who serves as the chair of Kim & Changs Health Practice Group. She is also a member of the Mergers & Acquisitions Practice Group and Corporate Governance Practice Group.

    As chair of the firm's health practice, Ms. Chung represents a broad range of companies in the pharmaceutical/medical device/food/cosmetic sectors, advising on corporate, regulatory, compliance, and general commercial law issues. Ms. Chung is expert on 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.



Myung Soon Chung
Foreign Attorney, Health Practice Group, Kim & Chang, Seoul, Korea

Presentation Material (Acrobat)





Yunjoh Lee
Attorney, Health Practice Group, Kim & Chang, Seoul, Korea



5:15 p.m.



Japan
Chia-Feng Lu, Esq.
Associate, Baker & McKenzie (Gaikokuho Joint Enterprise), Tokyo, Japan

    Speaker Bio

    Chia-Feng Lu assists clients in developing strategies for research and development, regulatory compliance, market access, and business development and licensing. He has extensive experience in formulating compliance strategies and devising compliance programs, and has overseen the implementation of the global compliance structure in more than 70 jurisdictions during his secondment with a multinational pharmaceutical company. In his current capacity, he serves as a leading compliance counsel to a flagship biotech company in Asia, and to one of the largest specialty pharmas in the world.

    Prior to joining the Firm, he worked at a multinational pharmaceutical company and a consulting firm. Chia-Feng also holds appointments as an adjunct academic of the Faculty of Medicine at Kyoto University, and the School of Pharmacy at Kitasato University in Japan.
    Presentation Material (Acrobat)



5:45 p.m.



Taiwan
Chester Chu
Director, Fraud Investigation & Dispute Services, EY, Taipei, Taiwan

    Speaker Bio

    Chester is a director from EY Taiwan, he has more than 14 years in forensic accounting, fraud investigation, anti-bribery and anti-corruption compliance, US Foreign Corrupt Practices Act (FCPA) compliance, internal controls testing and remediation and financial statement audit. He has extensive experiences in advising multinational companies (MNC) in establishing corporate governance and anti-fraud related policies needed to comply with capital markets listing rules. He has served clients in various industries, including pharmaceutical, financial services, diversified industrial products, high technology, telecommunication, consumer products and energy. He is a Certified Fraud Examiner, and a US Certified Public Accountant.



Kevin Y. H. Wang, LLM
Senior Consultant, Baker & McKenzie, Taipei, Taipei, Taiwan

    Speaker Bio

    Kevin Wang co-heads the Firms' Corporate/M&A Practice Group and China Practice Group in Taiwan. His practice areas include M&A, China investments, as well as general corporate and private equity work. In addition to his legal practice, Mr. Wang has written several articles and publications including Legal Practice Guide to Investment in China, Practical Guide to the PRC Labour Law and The Manual of the New PRC Labor Law.

    Mr. Wang's practice focuses on domestic and cross-border M&A, takeovers, corporate restructuring and China investments for both private and public corporations and investors. He also has extensive experience assisting clients in deal structuring and commercial negotiations, as well as risk management.
    Presentation Material (Acrobat)



6:15 p.m.



Adjournment












MINI SUMMIT XIV:




SOCIAL MEDIA AND TECHNOLOGY TOOLS FOR COMPLIANCE


4:45 p.m.

Case Studies on the Successful Use of Technology Tools in Compliance Programs

Clarissa SHEN, MBA
Country Compliance Officer, Global Compliance and Business Ethics, Sanofi, Shanghai, China

    Speaker Bio

    Clarissa Shen is Country Compliance Head, responsible for designing an effective Compliance Program for Sanofi China to uphold Sanofi Group's highest ethical standards.

    Clarissa has extensive business management experiences in the area of credit management, supply chain management; and distributorship and agent management with world's leading Pharmaceutical and Chemical companies. Since year 2009, Clarissa has progressed her career, having acted as acting compliance head for Bristol-Myers Squib (China) and associate compliance director for Eli Lilly Asia.

    Clarissa graduated from Shanghai University with a bachelor degree and obtained an UK accredited MBA degree from University of Canterbury, Christchurch New Zealand.
    Presentation Material (Acrobat)






Julie Tan
Senior Compliance Manager, AstraZeneca, Shanghai, China

    Speaker Bio

    As Sr. Compliance Manager in AstraZeneca China, Julie has taken various responsibilities in Compliance function, including investigation, auditing and business partnering. She had led the launch of the Data Analytics project in China to drive a risk-based governance framework.

    Prior to joining AstraZeneca, Julie has worked in compliance, auditing, internal control areas in Pharmaceutical & FMCG industries. She began her career at Deloitte (Shanghai) CPA firm.

    Julie received a degree in International Business Management from Fudan University in China and holds Certified Public Accountant certificate.



Karen Eryou
Senior Director, Corporate Compliance APAC, UCB Pharma, Shanghai, China (Moderator)

Presentation Material (Acrobat)



5:30 p.m.



Social Media Update
  • The Evolution of Social Media/Digital as Business Enabler
  • Social Listening
  • Compliance Considerations
Sandy S. Johnston
Partner, PwC, Shanghai, China

    Speaker Bio

    Sandy leads PwC's Consulting practice for the Life Sciences sector in China. He has over 20 years of experience in consulting mostly focused on the Life Sciences industry. He has considerable experience in business performance improvement and change management enabled by new technology. He has led a number of major performance improvement and cost reduction projects for many of the world's largest pharmaceutical companies. Recent examples include:
    • Project to transform the back-office and IT functions of a major Pharma company;
    • Project to develop and implement a balance scorecard to assist a greater drive toward cost efficiency across all functions;
    • A major transformation programme for the global development function;
    • Transformation of project management organization and processes for a global project management function covering all Phases of R&D;
    • Re-design of drug development project team, governance and operating model covering all Phases of Drug Development and Lifecycle management;
    • Cost reduction program covering all activities in Drug Development for one of the world's largest pharma companies.
    In addition he has led IT Strategy, IT Effectiveness and systems implementation projects for a number of major Pharma companies. He has co-authored and frequently presents many of PwC's Pharma thought leadership publications in meetings with specific clients and at conferences.
    Presentation Material (Acrobat)



6:15 p.m.



Adjournment




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