As you know, pharma compliance is a critical issue, particularly in China. The Chinese government’s recent crackdowns on the business practices of various pharmaceutical companies have sent shockwaves throughout the industry and the price to pay for non-compliance is exceedingly high, with massive revenue losses and irreclaimable reputational damages
To address this pertinent issue, IBC Asia is convening the forthcoming Pharma Compliance Summit
(Mar 2015) in Shanghai, China. Set to be an informative and insightful event, this conference will prepare participants in dealing with the latest legal compliance landmines and equip them with an in-depth understanding of how to mitigate non- compliance risks at every part of the pharma value chain.
Top companies will share best practices of internal compliance programs and third party due diligence strategies; Gain these exclusive insights and incorporate them into their own company, reaping maximum benefits.
Your expert speaker faculty includes:
• Leon Wang, Vice President, AstraZeneca China
• Heike Deters, Head of Compliance, Bayer Healthcare China
• Dr Wang Xianlin, Member, Expert Advisory Group of Anti-Monopoly Commission, State Council People’s Republic of China
• Maija Burtmanis, Regional Legal & Compliance Director JAPAC, AbbVie
• Gareth Lee, General Counsel & Head of Compliance APAC, Allergan
• Cristopher Landrito, Regional Compliance Manager APAC, Merck
• David Shen, General Counsel & VP Legal, AstraZeneca China
• Dr Wu Ke, President, Shanghai BravoBio
• Alejandro Castro, Regional Audit Manager Asia Pacific, Novartis
• Linda Ling, Senior Healthcare Compliance Manager, OTC China, Johnson & Johnson
http://www.pharmacompliance-china.com
1. www.pharmacompliance-china.com
Produced by:
International Marketing Partner:
Life
Sciences
IBC
LIFE SCIENCES
Pharmaceutical
16 - 19 March 2015
Grand Hyatt Shanghai, China
Where Pharma Leaders Connect to
Share Practical Experiences in China
2015 Expert Speakers Include:
Leon Wang
Vice President
Business Unit,
AstraZeneca, China
Heike Deters
Head of Compliance,
Bayer Healthcare,
China
Maija Burtmanis
Regional Compliance
Director JAPAC, Legal &
Compliance
AbbVie, Singapore
Gareth Lee
General Counsel & Head
of Compliance APAC,
Allergan, Singapore
• Legal Frameworks & Compliance
• Ethical Compliance Strategies
• Healthcare Reform in China & the Future for Pharma
• Best Practice Compliance Strategies
• Internal Controls & Risk Management
• Effective Third Party Compliance Strategies
TIMELY
TOPICS
INCLUDE:
Pre-Conference Workshop (16 March 2015)
Robust Internal Compliance Frameworks
Post-Conference Workshop (19 March 2015)
Third Party Due Diligence & Risk
Management
Workshops Not to be Missed!
Association: Media Partners:
Dr Wang Xianlin,
Professor & Vice Dean, SJTU
KoGuan Law School
Member, Expert Advisory
Group of Anti-Monopoly
Commission, State Council
People’s Republic of China
Register 3 Delegates
& the 4th Attends
for FREE!
Where Pharma Leaders Connect to
Share Practical Experiences in China
TIMELY
TOPICS
INCLUDE:
2. REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmacompliance-china.com
Pharmaceutical 17 March 2015
CONFERENCE DAY ONE
TUESDAY
PANELDISCUSSION
12:20 Networking Lunch
1:50 Promoting an Ethical Company Culture from the
Top-Down
• Developing a workplace culture of high moral standards and low
tolerance for unethical behaviour
• Enhancing your company’s reputational image
• Leveraging ethics as a key component in your branding strategy
to be a cut above the rest in China’s low trust business
environment
• Communicating this ethical business culture to stakeholders in
order to gain their trust and loyalty
• Developing robust ethics-centric company policies- encouraging
whistleblowing, voluntary disclosure etc
Gareth Lee, General Counsel & Head of Compliance,
Allergan, Singapore
Effective Third Party Compliance Strategies
2:30 Third Party Risk Management in Commercial Compliance
• Current issues with third party vendors- travel agents, event
organisers and advertising agencies etc.
• How to reduce corporate exposure, manage them and keep
them in check
• Having a competent risk management framework in place and
leave no stone unturned
• Anti-fraud and Anti-bribery checks
• Detecting wrongdoing and setting up red and green flags
throughout the due diligence process
Maija Burtmanis, Regional Compliance Director, JAPAC, Legal
& Compliance, AbbVie Singapore
3:10 Afternoon Refreshments
3:40 Compliance Challenges In Clinical Research
• Key compliance challenges faced by CROs
• Revising and improving internal audit procedures and managing
the higher expectations from Pharma companies
• Strategies for effective collaboration between both parties to
ensure the highest level of compliance
• Ensure you are protected in contractual agreements and
negotiation strategies with pharma companies
Dennis K. Barnes, Vice President, Global Compliance Officer,
Parexel International, U.S
4:20 Third Party Risk Management in CROs
• Early assessment of potential CROs to minimize risks- what to
look out for when selecting a CRO for your company
• Technology transfer risks in CROs and CMOs
• Developing mutually beneficial contracts including negotiating
audit rights and clear budget drafting
Dr Wu Ke, President, Shanghai BravoBio
5:00 Chairperson Closing Remarks
5:10 End of Conference Day One
8:00 Registration and Morning Coffee
9:00 Welcome from IBC Asia & Morning Ice Breaker
9:05 Chairman’s Welcome Remarks
Gareth Lee, General Counsel and Head of Compliance,
Allergan Singapore
Legal Frameworks & Compliance
9:10 Overview of Pharma Compliance Laws
• Latest updates, summary and developments on pharma
compliance laws
• Anti-Trust and Anti-Competition Laws and their implementation
in China
• Anti Bribery Laws and issues with compliance in pharma
companies
DrWang Xianlin, ProfessorandExecutiveViceDean, Shanghai
Jiao Tong University (SJTU) KoGuan Law School,
Member, Expert Advisory Group of Anti-Monopoly Commission,
State Council People’s Republic of China
9:50 An Overview of the Compliance Landscape in China
• What makes compliance in China such a challenging issue?
• Compliance issues and spotlight on the Pharma industry in China
• Implications of non-compliance
• Strategies for improving implementation of compliance policies
in companies
• What is needed for the pharma industry to move forward?
Panelists:
David Shen, General Counsel, VP Legal, AstraZeneca, China
Gareth Lee, General Counsel and Head of Compliance,
Allergan Singapore
10:30 Morning Networking & Refreshment Break
11:00 Pharmaceutical Laws, Enforcement & Implications
• Issues of increased global anti-corruption enforcement on pharma
companies
• Understanding their relevance and the implications on Pharma
companies in China
~ Foreign Corrupt Practices Act
~ New Consumer Protection Law
~ Data privacy Laws
• Current issues of increased investigations by the State
Administration for Industry and Commerce (SAIC), National
Development and Reform Commission (NDRC) and Public Security
Bureau (PSB)
• Understanding your rights and protection under PRC laws
Dr Henry Gao, Associate Professor of Law, School of Law,
Singapore Management University (SMU), Singapore
Ethical Compliance
11:40 Aligning Ethical Business Practices to the Domestic China
Business Environment
• What does ethical compliance really mean and its significant
impact on your company
• Understanding the China business landscape and how to fit in
• How to adapt your sales, marketing and distribution policies to
the context of China
• Aligning compliance programs to Chinese culture, social values
and business practices
• Analysis of the local codes of conduct and interactions with
Healthcare Providers
• Practices of giving gifts, grants and sponsorships, providing
dinners and holding events
• Practical do’s and don’ts when doing business in China
Leon Wang, Vice President, AstraZeneca, China
3. REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmacompliance-china.com
Pharmaceutical 18 March 2015
CONFERENCE DAY TWO
WEDNESDAY
9:00 Chairman’s Opening Remarks
Heike Deters, Head of Compliance, Bayer Healthcare, China
Best Practice Compliance Strategies
9:10 Breaking Down the Role of the Compliance Officer
• Issues related to governance, decision making and escalation
• Ensuring comprehensive reporting, clear accountability and
effective oversight by top decision makers
• Designing an internal reporting system – minimize fear of
retaliation and what protections do whistleblowers have
• What kind of disciplinary measures should be taken to hold non-
compliant employees accountable
Redentor Romero, Regional Compliance Officer,
Teva Pharmaceuticals, Singapore
9:50 Liaising with Third Party Compliance Monitors
• Selecting the right corporate compliance body that best suits
your company’s needs
• How to effectively interact and work with external monitors
• How differently do external monitors conduct compliance
assessments as compared to a company’s own internal audit
teams
• The use of data analytics and metrics to monitor and track
compliance, and to detect corruption/bribery schemes
Alejandro Castro, Regional Audit Manager, APAC,
Novartis Asia Pacific Pharmaceuticals, Singapore
10:30 Morning Refreshments
11:00 Transparency and Compliance in Sales Distribution
Channels
• Creating a good company-healthcare provider -patient
relationship: How to win business in the right way
• Ensuring high performance with high integrity among your sales
representatives
• Fundamentals of conducting fraud investigations – what you
need to pay attention to when conducting interviews
• What actions could be taken upon the discovery of foul play?
Titi Zhangjie, SeniorComplianceManager, Bausch & Laumb,
China
11:40 Internal Compliance Framework Strategies
• Best practices in monitoring and training of company staff to
encourage a culture of transparency and trust
• Audit to mitigate the risk of the most common vehicles and
schemes used
• Re-assessing the use of third party intermediaries
• Common pitfalls and challenges in internal compliance
frameworks
Moderator:
Dennis K. Barnes, Vice President, Global Compliance Officer,
Parexel International, U.S
Panelists:
Cristopher Landrito, Regional Compliance Manager APAC,
Merck, Singapore
Alejandro Castro, Regional Audit Manager, APAC,
Novartis Asia Pacific Pharmaceuticals, Singapore
Heike Deters, Head of Compliance, Bayer Healthcare, China
12:30 Networking Luncheon
China’s Healthcare Reform
2:00 China Healthcare Reform Implications and the Future
of Pharma
• How will the healthcare reform in China impact pharmaceutical
companies in the short and long run?
• Leveraging the benefits of increased privatization of hospitals
and market opportunities in the rural and suburban areas, low
cost generics, OTC sales and medical devices growth
• Being wary of the risks involving the more stringent handling
processes in public hospitals, pricing and promotion controls
• Drug price reductions and implementations of EDL (essential
drugs list) issue
Dr. Qian Jiwei, Research Fellow, NUS East Asian Institute,
Singapore
Internal Controls & Risk Management
2:40 Conducting Effective Risk Assessment Within Your
Company
• Evaluate the levels of quantitative and qualitative risk at each
point in the pharma value chain within your company
• Strategize where efforts should be focused and ways to minimise
resources, financial/ administrative burdens
• Using compliance risk assessment tools tailored specially to china
pharma industry risk factors
• Avoiding common pitfalls while conducting a risk assessment in
your organization
Heike Deters, Head of Compliance, Bayer Healthcare, China
3:20 Afternoon Refreshments
3:50 Implementing Effective Internal Controls in Your
Company to Ensure Compliance
• Allocating and monitoring the spending of grant funds
• Organize events and entertainment, hold medical conferences,
make travel arrangements and provide grants or sponsorships
to healthcare providers safely
• Procedures to follow when providing healthcare providers with
benefits
• Controls on free equipment provided for clinical trials
Linda Ling, Senior Healthcare Compliance Manager, OTC,
Johnson & Johnson, China
4:30 IP, Patent Issues & Risk Management
• Effective methods to improve chances of patent eligibility
• Strategies to protect your company in the short and long run
• Providing effective patent due diligence reviews on target
companies
• Protecting confidentiality, trade secrets, and attorney client
privilege during a diligence review
Dr Yihong Ying, IP Law, East China University of Political
Science and Law, China
5:10 Chairperson’s Closing Remarks
5:20 End of Conference Day Two
PANELDISCUSSION
4. REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmacompliance-china.com
Pharmaceutical WORKSHOPS
Pre-Conference Workshop A 16 March 2015 9.00am - 5.00pm
Robust Internal Compliance Frameworks
The task of ensuring compliance within the entire organization is not
an easy one, but with the right approach, you will be able to mitigate
non compliance risks and prevent corruption. This starts with a top
down approach with regards to policies, frameworks and protocols
which provide a pre-emptive methodology in nipping corruption in
the bud.
This practical and in-depth workshop will enable you to restructure
your internal compliance programs to incorporate recent changes
in enforcement priorities and develop internal controls and corporate
policies that create a culture of compliance and anti corruption
throughout your organization.
Equip yourself with the right tools to implementing a robust internal
compliance program in your company:
Establishing an effective compliance training framework
Strong monitoring processes and management
action/remediation plans
Transform your salesforce training strategies
Revamp your checks and internal controls
Pre-approval policy and procedures
Building up a culture of compliance and transparency amongst
all staff
Investigation of allegations
About Your Workshop Leader:
Linda Ling, Senior Healthcare Compliance Manager, OTC China, Johnson & Johnson, China
Linda Ling graduated from University of Shanghai (B.A) in 1994 and received her ComplianceTrain theTrainer (TTT) from the Siemens management
Institute. She began her accounting career and subsequently assumed the role of Finance manager for 4 years and then Quality and Process
manager for 2 years at Siemens. This was followed by 5 years of experience as a Compliance Officer at Siemens where she lead and implemented
effective compliance monitoring programs, performed unbiased anti-corruption risk assessment of key business processes and also conducted
compliance investigations, within operation companies of Siemens in China. Currently she has been working for close to 3 years as a Senior Healthcare
Compliance Manager of Johnson and Johnson China for OTC business where she received the Corporate Compliance and Ethical Professional – International
(CCEP-I) Certificate and Johnson&Johnson Healthcare Compliance on-board Program in 2013.
Post-Conference Workshop B 19 March 2015 9.00am - 5.00pm
Third Party Due Diligence and Risk Management
In high risk and “uncertain” operational environments, understanding
who you are doing business with and what they are doing is “business
critical”.
This interactive and practical workshop will take you on a deep-dive
discussionto“drilldown”intothenutsandboltsofvetting,monitoring,
auditing and terminating Third Parties in China.
Leave this session confidently with tools and best practice tips in
implementing effective Third Party compliance strategies as a
protective measure against potential FCPA, UK Bribery Act or local
law violations.
The workshop will equip participants with tips on how to create a
robust third-party compliance auditing program, which is
“preventative” rather than “reactive”.
Key topics will include:
Ensuring that the third parties are compliant with FCPA and
applicable anti-corruption laws
Effective third party risk management strategies
Detecting wrongdoing – setting up red and green flags
throughout the due diligence process
Implementing and maintaining effective policies and procedures
to monitor activities of subsidiaries, agents and distributors in
the supply chain.
Practical strategies for monitoring and auditing compliance of
Third Parties
Deciding when to terminate a relationship and “how to” tips
About Your Workshop Leader:
Maija Burtmanis, Regional Compliance Director JAPAC, Legal & Compliance, AbbVie, Singapore
Maija currently holds the position of Regional Compliance Director with AbbVie BioPharma, with oversight over Japan / Asia Pacific. She is a
qualified Australian lawyer (LLB/BSc) and also holds a Master of Laws obtained from the University of New South Wales, Australia. Maija has been
working in the Life Sciences industry in various regional legal / compliance roles for the last 12 years: previously, she held the position of Associate
General Counsel of Alcon (A Novartis Company) and also Regional Counsel & Chief Compliance Officer for Pfizer Asia Pacific.
5. IBC
LIFE SCIENCES
Pharmaceutical
16 - 19 March 2015
Grand Hyatt Shanghai, China
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmacompliance-china.com
GEOGRAPHY
■ China/Hong Kong 50%
■ Korea/Japan 10%
■ Taiwan 10%
■ South East Asia 10%
■ Europe 10%
■ USA/Rest of World 10%
Pharma compliance is a critical issue, particularly in China. The recent
crackdowns on business practices of various pharmaceutical companies
has sent shockwaves throughout the industry. The price to pay for
non-compliance is exceedingly high, with massive revenue losses and
irreclaimable reputational damages.
IBC Asia’s Pharma Compliance conference will prepare participants in
dealing with the latest legal compliance landmines and equip them
with an in-depth understanding of how to mitigate non- compliance
risks at every part of the pharma value chain. Participants will gain
invaluable insights into best practices pertaining to internal compliance
programs and third party due diligence strategies from top companies,
and incorporate them into daily business practices, reaping maximum
benefits.
With its exclusive focus on China, this conference is well placed in
addressing the needs and challenges specific to doing business in the
unique and complex China landscape.
With a crisp yet insightful agenda tailored to explore only the most
pertinent and timely issues, this conference will deep dive with in depth
discussions on relevant compliance issues plaguing the industry today.
Top Reasons to Attend:
Navigate through the latest ‘legal landmines’ in pharma
compliance
Understand recent government enforcement implications
on the pharma industry and make sure you are thoroughly
prepared and protected
Benchmark against your peers in cost effective Internal
compliance program frameworks and conducting top-
down risk assessments within your organisation
Gain an insight into effective third party risk management
and due diligence strategies
Who Should Attend
INDUSTRY BREAKDOWN
■ Pharmaceuticals 30%
■ Biotech 10%
■ Medical devices 10%
■ Government/ Regulatory Agencies
2.5%
■ CROs 10%
■ Law Firms 20%
■ Financial Advisory firms 10%
■ Risk Management Consultants 5%
■ Life Science Compliance Metrics
Solutions 2.5%
Why You Should Sponsor:
Position your company as a market leader at this event and our
customized Sponsorship & Exhibition package offers prime exposure
to key decision-makers and exceptional branding.To explore the range
of thought leadership, speaking, branding and marketing
opportunities available, please contact:
Yvonne Leong
+65-6508-2489
yvonne.leong@ibcasia.com.sg
“China poses unique compliance challenges for pharmaceutical companies,
with several well-known foreign companies getting caught up in corruption investigations
in the past years... In recent years, there were 10 investigations under the FCPA involving alleged
violations in China by pharmaceutical and medical device makers. Finally, it’s been long known that
the structure of the healthcare system and business environment in China creates a high-risk industry.”
~ Pharma Compliance Monitor, April 2014
6. This label contains your priority booking code. To expedite registration, please do not remove label. If you have
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