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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Day 2 | Day 3

         Preconference and Day I
   Tuesday, September 16, 2014






    7:00 a.m.



Registration Commences




    PRECONFERENCE: COMPLIANCE CONCERNS IN NEGOTIATING, IMPLEMENTING AND MANAGING, AUDITING AND
     MONITORING THIRD PARTY RELATIONSHIPS IN THE ASIA PACIFIC REGION









  • Identifying and Conducting Due Diligence on Third Party Intermediaries
    • Defining Third Party Intermediaries
    • Assessing the current state -- Sources of information, filtering, cost-effective solutions
    • Defining risk prioritization of third party relationships and the degree and approach of due diligence
    • Red flags you need to consider for different categories of third party relationships
    • Conducting training and monitoring of your third parties
    • Use of corporate intelligence to confirm self-reported information and evaluate integrity of business partners
  • Negotiating with Third Parties to Include Enforceable Rights to Audit and Ongoing Monitoring
    • Best practices in contracting including the use of arbitration and venue specificity
    • Managing and understanding cultural sensitivities to create collaborative results for success
    • Examples of successful negotiations that have resulted in cost effective auditing and monitoring
  • Implementing and Managing Third Party Audit Rights and Ongoing Monitoring of Relationships
    • Balancing stake holder and regulatory expectations versus practical implementation challenges
    • Enforcing rights and implementing ongoing monitoring without negatively impacting business relationships
    • Examples of successful audits and monitoring relationships
  • Best Practices in Ongoing Auditing and Monitoring Third Party Relationships



8:00 a.m.




Introductions, Presentations and Q&A

Benjamin Ee
Associate Director, PwC, Singapore

    Speaker Bio

    Benjamin, a Singapore Chartered Accountant, is an associate director in PwC's Forensic Services practice in Singapore. Benjamin has three years of internal audit experience with a Fortune 500 Oil and Gas company and a Singapore-listed transport company. He has an additional eleven years of consulting experience with the Big Four accounting firms in Singapore and Beijing and helped clients in the pharmaceutical, medical device, agricultural and natural resources industries in a number of jurisdictions. He has led forensic accounting investigations, anti-bribery/corruption compliance due-diligence reviews and internal control reviews His work has taken him across East Asia, the Middle East, Central Asia, and to the UK and the US.






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

    Speaker Bio

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






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).






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






John Tsai
Partner, Fraud Investigation & Dispute Services, EY, Shanghai, China






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

    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.






Wendy L. Wysong, Esq.
Partner, Clifford Chance LLP; Former Assistant US Attorney, US Attorney's Office - District of Columbia; Former Deputy Assistant Secretary for Export Enforcement, Bureau of Industry & Security, UA Department of Commerce, Hong Kong and Washington, DC, USA (Co-moderator)

    Speaker Bio

    Wendy L. Wysong, a litigation partner with Clifford Chance, maintains offices in Hong Kong and Washington, D.C. She offers advice and representation on compliance and enforcement under the FCPA, as well as other international trade laws. Ms. Wysong combines her experience as a former federal prosecutor with her regulatory background at the U.S. Department of Commerce. Chambers Asia writes, "Anti-corruption practitioner Wendy Wysong lends the team a keen edge on the anti-corruption scene, and is hailed by peers as a US Foreign Corrupt Practices Act (FCPA) specialist par excellence. She is seen as "a leading expert with a huge depth of experience."
    Presentation Material (Acrobat)
    Case Study Material (Acrobat)
    Handout Material (Acrobat)
    Handout Material (Acrobat)
    Handout Material (Acrobat)



12:00 p.m.




Adjournment




    Day I: Asia Pacific Pharma Congress
    Tuesday, September 16, 2014






    OPENING PLENARY SESSION




1:00 p.m.




Welcome and Introductions: Asia Pacific Pharma Congress Vision and Overview

Maija Burtmanis, LLB/BSc, LLM
Regional Compliance Director, JAPAC, AbbVie BioPharmaceuticals, Singapore (Co-chair)

    Speaker Bio

    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 Pfizer and Novartis in Asia Pacific.

    In her current role, Maija supports Russia and Asia Pacific for the Alcon Division within the Novartis Group as Associate General Counsel and Country Compliance Officer (for Singapore).

    A large part of her work involves providing legal advice and assistance on complex corporate, commercial, BD&L, labour law and compliance matters.






Karen Eryou
Senior Director, Corporate Compliance APAC, UCB Pharma, Shanghai, China (Co-chair)






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

    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.






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.










1:30 p.m.




Perspectives from the C-Suite: Ethical Business Practice for Pharmaceutical Companies in the Asia Pacific Region

David Snow, MBA
President, China and Hong Kong, AstraZeneca, Shanghai, China

    Speaker Bio

    David Snow leads the AstraZeneca China and Hong Kong organizations. In 2013, AZ China grew by 19% to more than $1.8B in China sales and now employs more than 7,000 employees across 4 business units. AZ has had a presence in China for more than 50 years, entering the modern era in 2001 with the opening of the Wuxi manufacturing site. Since then, AZ has continued to invest heavily in China, and especially focused on research and development across diseases affecting Asian patients.

    David has more than 25 years of commercial business experience across many leadership roles and therapeutic areas. Previously, he served as Vice President of the United States Cornerstone Business Unit in Wilmington, Delaware. Under his leadership, this business achieved $4 Billion in 2011 sales across a diverse portfolio of over 20 brands. David has been with AZ since 2001 and prior to AZ, worked in other US and German Pharmaceutical companies.

    David earned his BA in Marketing from Auburn University and his MBA from the Stern School of Business (NYU).






Veronique Toully
MBA, DVM, Managing Director, China, UCB, Shanghai, China

    Speaker Bio

    Veronique Toully joined UCB in 2004 and has been appointed Managing Director of UCB China, based in Shanghai, in January 2013. She was previously Managing Director for UCB Australia and New Zealand. Starting in 2004, she set up the Global Market Access group in UCB and held the position of Vice President G3P - Global Patients, Payers and Providers - in charge of Global Outcomes Research & Pricing/Reimbursement strategies, Market Research and Marketing & Access Innovation until 2010.

    Prior joining UCB, Veronique had 10 years consulting experience in pricing and reimbursement for drugs and medical devices, working for leading Fortune 500 pharmaceutical companies and biotech firms. She is a Doctor in Veterinary Medicine with a MBA (HEC, Paris) and a Diploma in Health Economics from the University of York (UK).






Shirley Zhao, MBA
President, Allergan China; Former Managing Director, China, Genzyme; Commercial Director, BioScience, Japan, China and North Asia, Baxter Asia Pacific; Former Vice President, Lilly China; Former Oncology Division Product Manager, Bristol-Myers Squibb, Shanghai, China

    Speaker Bio

    Ms. Shirley ZHAO joined Allergan China in July 2012 as Country President of Allergan China. She is in charge of Allergan Business in China.

    As one of the earliest China native professionals actively working in pharmaceutical industry, Shirley ZHAO witnessed the evolving development of China healthcare market with solid in-field experience in pharmaceutical market operation and management in past 20 years. She has an understanding of China pharmaceutical market relying on comprehensive knowledge on China market and culture, and she accumulated rich experience and successful credit on business management and strategic planning.






Ted Acosta, Esq.
Principal, EY; Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services, New York, NY, USA and Paris, France (Moderator)

    Speaker Bio

    Mr. Acosta is the Global Leader of the Life Sciences Fraud Investigation & Dispute Services team. He specializes in assisting pharmaceutical manufacturers, biotechnology and medical device companies with internal and government investigations, global compliance assessments and compliance structure development.

    Mr. Acosta assists in-house and outside counsels in fraud investigations, due diligence, compliance inquiries and litigation strategy issues. Mr. Acosta has vast experience working with legal counsels, internal audit functions, and compliance teams in matters throughout the US, Europe, Asia and Oceania under the Foreign Corrupt Practices Act ("FCPA") and numerous country-specific anti-corruption and competition laws, as well as drug/device regulatory schemes.

    Prior to joining Ernst & Young, Mr. Acosta was a Senior Counsel at the Office of Counsel to the Inspector General of the Office of Inspector General, U.S. Department of Health and Human Services ("OIG - HHS") in Washington, DC.

    Mr. Acosta holds a Juris Doctorate and a Masters in Health Administration degrees. Mr. Acosta works out the New York and Paris EY offices.










2:45 p.m.




Asia Pacific Compliance Issues from a Global Perspective

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.
    Presentation Material (Acrobat)










3:15 p.m.



Break










3:45 p.m.




The Patient Perspective

Kin Ping Tsang
Chair, International Alliance of Patients Organizations (IAPO) Founder, Retina Hong Kong; Past Chair, Alliance for Patients, Mutual Help Organizations (APMHO), Hong Kong

    Speaker Bio

    Mr Kin Ping Tsang is Governing Board Member and Chair of International Alliance of Patients' Organizations (IAPO) currently.

    Mr. Tsang is retired business executive and has been volunteering in local and international patient movements for decades. Mr Tsang advocates access to treatment, patient safety, medical ethics and patient engagement in the healthcare sector.
    Presentation Material (Acrobat)






Erinn Hutchinson
Partner, Advisory Services, PwC Consultants (Shenzhen) Limited, Shanghai, China (Moderator)

    Speaker Bio

    Erinn Hutchinson is a Partner in PwC's Pharmaceutical and Life Sciences Practice, based in Shanghai. Erinn has fifteen years of experience providing business advisory services to pharmaceutical and medical device companies in the areas of compliance , risk management, and performance improvement. Her expertise includes providing comprehensive risk assessment services on a broad range of health care and pharmaceutical operational issues including corporate compliance, monitoring and auditing, corporate integrity agreements, commercial regulations, reimbursement, anti-bribery, and due diligence for mergers and acquisitions. In addition to extensive experience in the U.S. and China, Erinn has performed compliance assessment reviews in Brazil, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Italy, Mexico, Poland, Portugal, Russia, and the Ukraine.










4:15 p.m.




Key Issues Overview/Mini Summit Preview

Training on Compliance and Ethics Basics
(For greater detail please attend related Mini Summits I, VI & XI.)
Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC, USA

    Speaker Bio

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






Chinese Criminal Law Issues for Companies and Executives
(For greater detail please attend related Mini Summit V.)
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).
    Presentation Material (Acrobat)






Anti-Corruption, including FCPA and UK Bribery Act
(For greater detail please attend related Mini Summit V.)
Lars Eckerlein
Partner, Fraud Investigation & Dispute Services, EY, Beijing, China

    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)






Tendering, Payment and Reimbursement
(For greater detail please attend related Mini Summit IX.)
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.






Advanced Issues in Global Transparency, Disclosure, Aggregate Spend and Sunshine
(For greater detail please attend related Mini Summit II.)
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

    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.






The Role of Forensics in Compliance
(For greater detail please attend related Mini Summit X.)
Ramesh Moosa
Partner, Forensic Technology Solutions, PwC, Shanghai

    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.






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.










6:00 p.m.



Adjournment and Networking Reception




Go to Agenda:
Day 2 | Day 3




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