AGENDA: PRECONFERENCE/DAY I
MONDAY, SEPTEMBER 10, 2018
7:00 am
PRECONFERENCE SYMPOSIUM: COMPLIANCE AND ETHICAL ISSUES IN PATIENT ACCESS AND SUPPORT PROGRAMS AND ACTIVITIES WITH PATIENTS AND PATIENT ADVOCACY ORGANIZATIONS
(Optional; Separate Registration Required)
- Definitions matter — What are we talking about? What are our business colleagues talking about? Is it the same?
- What are the most common manifestations or structures of Patient Support Programs?
- What are the risks associated with these common activities? How do these risks “show up” — especially in relation to other activities?
- What are best practices for governance and approvals of these activities?
- How do you monitor these activities?
8:00 am
Welcome and Overview
Regional Compliance Director, Japan/Asia Pacific, Shire; Former Healthcare Compliance Officer, Asia Pacific, Medical Sciences, Johnson & Johnson; Former Associate General Counsel, Alcon Russia; Former Asia Pacific, Country Compliance Officer, Novartis SG, Singapore
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.
Legal and Compliance Director (APAC), Ferring Pharmaceuticals; Former Director, Legal and Compliance, Asia Pacific, Zimmer Biomet, Singapore
Director, Life Sciences Regulatory & Compliance, Navigant Consulting, Inc., Chicago, IL, USA
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
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.
Executive Director, Anti-Bribery and Anti-Corruption Compliance Interim Head, South East South Asia Oceania Ethics and Compliance, ASTELLAS US LLC, Northbrook, IL, USA
Director, Life Sciences Regulatory & Compliance, Navigant Consulting, Inc.; Former Senior Vice President, Chief Compliance Officer, Biogen; Former Co-chair, International Pharmaceutical and Medical Device Compliance Congress, Boston, MA, USA (Moderator)
12:00 pm
Preconference Adjournment/Lunch on your Own
DAY I OPENING PLENARY SESSION
1:00 pm
Co-Chair Welcome, Introductions and Congress Overview
Regional Compliance Director, Japan/ Asia Pacific, Shire; Former Healthcare Compliance Officer, Asia Pacific Medical Sciences, Johnson & Johnson; Former Associate General Counsel, Alcon Russia; Former Asia Pacific, Country Compliance Officer, Novartis SG, Singapore (Co-chair)
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.
Chief Ethics and Compliance Officer, Asia Pacific, Medtronic, Covidien Private Limited; Chair, Legal, Ethics and Compliance Committee, Asia Pacific Medical Technology Association (APACMed), Singapore (Co-chair)
Legal and Compliance Director (APAC), Ferring Pharmaceuticals; Former Director, Legal and Compliance, Asia Pacific, Zimmer Biomet, Singapore (Co-chair)
APAC Ethics and Compliance Lead, UCB Pharma; Former Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Shanghai, China (Co-chair)
1:15 pm
Ethics and Compliance in Perspective
Country President, AstraZeneca; President, Singapore Association of Pharmaceutical Industries; Co-chair, Healthcare Committee, European Chamber of Commerce in Singapore (EuroCham), Singapore
1:30 pm
Talk About Ethics is Confused by the Word “Ethics”
Associate Professor of Decision Sciences, INSEAD Singapore; Co-director, INSEAD Leadership Programme for Senior Executives, Singapore
He teaches courses on decision making, storytelling, and ethics. He himself is the subject of his current experiments. The main research question is “How can we improve our daily practices in order to increase our performance and live excellent human lives?”
Neil Bearden is co-directing the INSEAD Leadership Programme for Senior Executives – India.
2:00 pm
Update on the Revised IFPMA Code, the APEC Code and Other Pharma and Med Device Global Codes
Chief Ethics and Compliance Officer, Asia Pacific, Medtronic, Covidien Private Limited; Chair, Legal, Ethics and Compliance Committee, Asia Pacific Medical Technology Association (APACMed), Singapore
Managing Director, Association of Voluntary Self Regulation for the Pharmaceutical Industry; Co-Chair of the IFPMA Ethics and Business Integrity Committee, Berlin, Germany
Presentation Material 1 (Acrobat)
Presentation Material 2 (Acrobat)
Country President, AstraZeneca; President, Singapore Association of Pharmaceutical Industries; Co-chair, Healthcare Committee, European Chamber of Commerce in Singapore (EuroCham), Singapore
Canadian Head of Compliance and Ethics Solutions, IQVIA; Former Executive Director, Ethics and Compliance, Innovative Medicines Canada; Former Industry Co-Chair Designate, APEC Biopharmaceutical Working Group on Ethics, Ottawa, Canada
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.
Legal and Compliance Consultancy Professional (Asia Pacific); Former Vice President and Associate General Counsel, Asia Pacific/Japan, GlaxoSmithKline plc, Singapore (Moderator)
Currently, Ms. Thakerar is an Associate member respectively of APACMed, Singapore Academy of Law, SIArb, Singapore Corporate Counsel Association and co-convenor of its Well-Being Chapter.
She is an experienced manager of large in house legal/compliance teams, legal budgets; external legal services spend/managing external law firms. Her experience is in project, transaction, stakeholder management and organization skills complex matrix management and legal/regulatory/investigations (FCPA/U.K. Bribery Act advisory work). Ms. Thakerar is also experienced in business and functions (finance/tax/HR/supply chain/procurement) partner and crisis management.
2:45 pm
Asia Pac Hot Compliance Markets Updates
Lei Li, LLM
Partner, Sidley Austin; Former Third Secretary, Ministry of Commerce, People’s Republic of China, Beijing, China
Cahyani Endahayu
Partner, Baker McKenzie, Jakarta, Indonesia
Yunjoh Lee, B.Jur, LL.M
Attorney, Kim & Chang Law Firm
Ms. Lee counsels multinational clients in the pharmaceutical, medical device and food industries on Korean regulatory compliance, corporate governance, competition law issues, and general corporate and commercial law matters. In particular, Ms. Lee counsels drug and device clients on various facets of anti-corruption compliance, such as designing and implementing effective compliance programs, employee training, monitoring, internal investigations, corrective action and remedial measures.
Her representative matters include representing pharmaceutical companies in investigations by the Korea Fair Trade Commission into alleged competition law violations relating to marketing and sales practices and defending pharmaceutical companies before the Korea Fair Trade Commission and the Ministry of Food & Drug Safety on charges of illegal interactions with healthcare professionals.
Eddie Chuah
Partner, Dispute Resolution Practice Group, Wong Partners, Kuala Lumpur, Malaysia
Eddie has undertaken a wide variety of briefs involving substantive law issues ranging from complex commercial transactions, insolvency litigation, shareholder disputes, construction, employment and administrative law. He also focuses on compliance issues, in particular, anti-corruption investigation, government procurement, audit and prevention.
Eddie regularly advises and assists both domestic and multinational corporations on a broad range of risk-related issues in compliance with both local and foreign authorities. His experience includes conducting internal investigations and audits, developing internal policies and procedures, as well as providing the necessary training to mitigate risks of fraud and corruption.
He has assisted and represented major corporations on external investigations by the Department of Justice and Securities Exchange Commission, the United Kingdom Serious Fraud Office, Singapore Corrupt Practices Investigation Bureau as well as the Malaysian Anti-Corruption Commission Agency.
Anh Nguyen Xuan, MBA
Chief Compliance Officer, Vietnam and Indochina, Sanofi Aventis, Ho Chi Minh City, Vietnam
APAC Ethics and Compliance Lead, UCB Pharma; Former Executive Director, Regional Compliance Officer, Asia Pacific and India, Merck Sharp and Dohme (Asia Ltd.), Shanghai, China (Moderator)
3:30 pm
Break
4:00 pm
The Regulation of Direct Sponsorships in the Asia Pac Region
Chief Ethics and Compliance Officer, Asia Pacific, Medtronic, Covidien Private Limited; Chair, Legal, Ethics and Compliance Committee, Asia Pacific Medical Technology Association (APACMed), Singapore
EAMEA Regional Compliance Head (Russia/CIS, Indian sub-continent, MEA), Shire; Former Regional Compliance Director (Asia and Russia), Alcon Laboratories, Inc.; Former Business Practices Officer (Asia, Middle East, Africa, Latin America), Novartis International AG, United Arab Emirates
Vice President, Ethics and Compliance Officer, Asia Pacific and Japan Global Ethics and Compliance, GSK, Singapore
Life Sciences and Healthcare Sustainability Leader, Strategic and Reputation Risk Leader, Risk Advisory, Deloitte; Former IS Lead, Global Commercial Organization, Astra Zeneca, Singapore (Moderator)
4:45 pm
The Challenges of Measuring Corruption in Healthcare
Director, Pharmaceuticals and Healthcare Programme, Transparency International UK; Former Director Global Health, Royal College of Obstetricians and Gynaecologists; Former Head, Government Relations, World Vision UK; Former Vice Consul, British Embassy, Copenhagen, Deputy Head of Mission, British Embassy, Bratislava, Deputy High Commissioner, Freetown, London, UK
5:15 pm
Annual Leading Compliance Officer Roundtable
Global Monitoring Leader and ASEAN Chief Compliance Officer, GE Healthcare, Singapore
Executive Vice President, Chief Ethics and Compliance Officer, Ipsen; Honorary President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
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
Asia Pacific Managing Partner, Forensic and Integrity Services, EY, Shanghai, China (Moderator)
He helps companies and their legal advisers deal with complex issues of fraud, corruption, regulatory compliance and business disputes. In the life sciences sector, Emmanuel has led numerous enquiries involving suspected improper practices by medical representatives, third party vendors and distributors.
Emmanuel has over 23 years of experience in fraud and financial statement investigations, anti-bribery/anti-corruption reviews, transactions forensics and litigation support, including 20 years in Hong Kong and Shanghai. He has also given evidence on accounting and valuation questions in arbitration proceedings.
Before coming to Asia in 1997, he worked in Paris on litigation support, due diligence and statutory audits.
6:15 pm
Adjournment and Networking Reception