CHINA’S MOST RENOWNED - giievent.kr · pharmaceutical compliance challenges and issues, driving...
Transcript of CHINA’S MOST RENOWNED - giievent.kr · pharmaceutical compliance challenges and issues, driving...
IBCLIFE SCIENCES
Part of
www.pharmacompliance-china.com
NEW IN 2017!Compliance Controls & Practices
in China
Practical issues in IPR Protection Policy and its legal implications in
China
Big Data Analytics as a compliance tool for Pharma
FMV - Process to engage HCPs + HCOs
Panel Discussion: Enhancing 3rd Party Risk Management
Ensuring Ethical and Efficient Medical Communication by
Pharmaceutical Companies in China
Leading the Compliance function into a New Era
PRE CONFERENCE WORKSHOP
27 MARCH
IP AND COMPETITION
POLICY IN CHINA
CHINA’S MOST RENOWNED PHARMACEUTICAL COMPLIANCE EVENT
FEATURING INDUSTRY LEADERS
Patrick Kos VP Compliance Roche
Sharon Xie Regional Quality Compliance & QP Reckitt Benckiser
Jian Li Medical Affairs Director, Medical Information and Compliance AstraZeneca
Titi Zhang Director, China Governance Operations GlaxoSmithKline
Jifeng Shi Director of Compliance and Registration Department Fosun Pharma Group
Alejandro Castro Regional Head Internal Audit Novartis Asia Pacific Pharmaceuticals
Clarissa Shen Vice President, China Compliance Officer Sanofi
David Shen VP Legal, General Counsel AstraZeneca
Wong Chae Sing Head of Regional Compliance, (APAC, MEA and LATM) Mundipharma
Albert Van Maaren Regional Compliance Officer APAC Merck Group
International Marketing Partner Produced by Media PartnersAssociate Sponsor
“IT WAS REALLY GREAT & VERY PRODUCTIVE. I WILL CERTAINLY ATTEND NEXT YEAR.”Li Jin, Production Director, Bravovax Co.,Ltd.
Plus
ATTRACTIVE GROUP
DISCOUNTS AVAILABLE!
SEE REGISTRATION PAGE FOR DETAILS!DEDICATED
NETWORKING AREA FOR PHARMA
COMPLIANCE DELEGATES
Exhibitor
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8:00 Registration Opens & Morning Coffee
8:50 Welcome Address from IBC Asia & Ice Breaker
9:00 Chairperson’s Opening Remarks
A STRATEGIC LOOK AT COMPLIANCE
9:10 Leading the Compliance Function into a New Era• Addressing the challenges in the market environment with
high turnover rate in compliance teams across industries• What should the compliance manager of the future be like?• How to attract the right people for a Compliance
Function of the Next Generation and how to create the stability in a compliance team needed?
• How could the future operations of a Compliance Function look like?
Patrick Kos, Vice President-Compliance China, Roche, China
9:50 Building a Values and Ethics Based Culture • Values and Ethics as an essential element of
compliance program • How do we encourage value based behavior?• Addressing challenges in ethics• Local market considerationsTiti Zhang, Director, China Governance Operations, GlaxoSmithKline
10:30 Morning Networking Break
11:00 Compliance Controls & Practices in China • Challenges unique to the China Pharma industry • Typical breaches, and how enforcement bodies
respond• Communicating standards and guidelines among
employees• Building a culture of compliance - Compliance
Champion Program Clarissa Shen, Vice President, China Compliance Officer, Sanofi, China
11:40 FMV - Process to engage HCPs + HCOs• Overview of Health Care Professional Interaction and
the common risks • What is the FMV for legitimate professional services?• Where are the grey areas and how to combat them?• Case Study Joyce Wong, Managing Director Asia Pacific, Polaris Solution Ltd
12:10 Local Regulatory Reforms and their Impact on Compliance • Update on China’s antitrust enforcement• Legislative reform in healthcare system and its impact
on compliance• Analysing industry trends in IP drugs and branded
generics • Enhanced enforcement of anti-corruption and anti-
bribery regulations • Recent investigations and how companies have fallen
shortPanelists:Xiangjun Kong, Head of Legal, Sanofi, China Sharon Xie, Regional Quality Compliance & QP, Reckitt Benckiser, ChinaTom Chan, Head of Legal - Greater China, Takeda, ChinaMore panelists to be confirmed
13:00 Networking Lunch
GMP AND DATA INTEGRITY
14:00 Big Data Analytics as a Compliance Tool for Pharma• An overview of how analytics are impacting Pharma• Using data analytics to detect emerging risks • Setting the right KPI’s - How do you apply metrics and
benchmarks to assess effectiveness?• Moving compliance monitoring beyond traditional
approaches to more technology enabled methodsWong Chae Sing, Head of Regional Compliance, (APAC, MEA and LATM), Mundipharma
14:30 Data Integrity in GMP Systems• Understanding Data integrity and its impact in
pharmaceutical sector• Applying the related regulations • Real life case study in GMP systems Sharon Xie, Regional Quality Compliance & QP, Reckitt Benckiser, China
15:00 Compliance for New Facility Project Management• Bio/Pharmaceutical Facility of the Future (FoF)• Project Management practice of GMP pharmaceutical
facility• Review of ASTM E2500 and other relevant guides from
FDA/ EMA/ CFDA/ ICH/ ISPE/ PDA• Engineering Discipline• Project Management Process• Practical integration of regulations, guidance and
standards with Project Management practiceMichael Lee, Project Director, BeiGene Biotech Company
15:40 Afternoon Tea
RISK MANAGEMENT AND 3RD PARTIES
16:10 Integrating Risk Management into the Compliance program• Aligning compliance activities with overall corporate
strategy• Assessing the risk profile that needs to be covered • Designing an effective compliance programme Alejandro Castro, Regional Head Internal Audit, Novartis Asia Pacific Pharmaceuticals, Singapore
16:40 Enhancing 3rd Party Risk Management • Recent trends in 3rd party compliance problems • Identifying the changing risks in role of 3rd parties • Practical checkpoints in selection, due diligence and
onboarding, contracting, performance management and monitoring, up to termination
• Avoiding common pitfalls Panelists:Vanessa Han Jun, Compliance Director, Novo Nordisk China Pharmaceuticals Co LtdIvan Wong, Head of Compliance GSK China and Hong Kong, GlaxosmithklineAngelia Lee, Compliance Senior Manager, AmgenMore panelists to be confirmed
17:30 End of Conference Day 1
CONFERENCE DAY ONE TUESDAY 28 MARCH 2017PA
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“GENERALLY INFORMATIVE AND LEARN A LOT FROM THE SPEAKERS”Country Compliance Officer, Sanofi
8:50 Welcome Address from IBC Asia & Ice Breaker
8:55 Chairperson’s Opening Remarks
LICENSING, MARKETING AND IP PROTECTION
9:10 Chinese Regulatory Reforms and its Impact on Drug registration· Introduction of new registration classification and its impact· Priority review policy and the current situation· Introduction of linking review between excipients,
packages and drug applicationJifeng Shi, Director of Compliance and Registration Department, Fosun Pharma Group & Former Reviewer, CDE, CFDA
9:50 Practical issues in IPR Protection Policy and its legal implications in China• Update on China’s enforcement of anti-monopoly law • Understanding Chinese legal system to patent
enforcement• Identifying the degree of risks to domestic companies
and MNC’s David Shen, VP Legal, General Counsel, AstraZeneca China
10:30 Morning Tea Break
11:00 Ethical Sales and Marketing• Promo vs Non-Promo activities• Regulatory measures in the use of social media
(Facebook, twitter etc)• Other items or activities that the pharmaceutical
company may giveMarx Zhou, Head of Compliance - Greater China, Takeda (China) Holdings Co Ltd
11:40 Ensuring Ethical and Efficient Medical Communication by Pharmaceutical Companies in China• Developing an effective and risk free campaign• Creating programs to effectively achieve desired objectives• Integrating risk management into industry compliant
communication programsJian Li, Medical Affairs Director, Medical Information and Compliance, AstraZeneca
12:20 Off-Label Drug Use and Promotion • Overview of Chinese regulations for use of off –label drugs• How are off-label advertisements and promotions regulated?• Off-label prescribing practices and implications • Civil liability and regulatory penalties For speaking opportunity please contact [email protected]
13:00 Networking Lunch
COMPLIANCE ROI
14:00 Measuring the Effectiveness of a Compliance Program• How to quantify the benefit of a compliance function?• Examples of metrics to measure compliance
effectiveness • Technology as a tool to evaluate the compliance
programAlbert Van Maaren, Regional Compliance Officer APAC, Merck Group
14:30 How to Attract the Right people for a Compliance Function of the Next Generation?• Identifying the right skills for a compliance professional • Continuing development and major career
advancement• Closing the cultural gap to promote ethical cultureJohn Kivel, Head of Asia Pacific Recruitment, GlaxoSmithKline
15:00 Environment Health & Safety (EHS) Compliance and Mitigating Risks• Assessing EHS barriers in China• Creating an EHS culture• Common problem areas • A checklist for EHS compliance Steven Yang, EHS/Compliance Manager, Teva Pharmaceuticals
15:30 Afternoon Tea
16:00 Meeting the Demands for a Changing Compliance function in the next decade • Assessing future risk and requirements• Managing the continued diversity in compliance
operations • Role of digital technology and analytics• Long-term view of managing risks and operating a
compliance modelPanelists: Albert Van Maaren, Regional Compliance Officer APAC, Merck Group Wong Chae Sing, Head of Regional Compliance, (APAC, MEA and LATM), Mundipharma More panelists to be confirmed
www.pharmacompliance-china.com
CONFERENCE DAY TWO WEDNESDAY 29 MARCH 2017
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PRE CONFERENCE WORKSHOPIP and Competition Policy in China 27 March 2017 (9am – 4pm)
In recent months, there is an increasing scrutiny by enforcement agencies against anti-competitive agreements and abuse of dominance relating to IP. The enforcement of China’s Anti-Monopoly Law (“AML”) has led to convergence with IP law which seeks to protect consumer welfare. How should domestic and international pharma compliance develop an integrated IP protection strategy? How will AML enforcement shape up internal control and external engagement?
This workshop aims to deliver understanding on latest the legislative initiatives and enforcement activities. It will include practical cases and IP-business models to help you design business policies and evaluate the potential risks under the AML.
Michelle Gon Partner McDermott Will & Emery
Michelle is stationed at the firm’s strategic alliance office, MWE China Law Offices, in Shanghai. Her practice focuses on compliance and regulatory matters, including anti-corruption, unfair competition, anti-monopoly and anti-fraud representations.
Wilson Wan Partner McDermott Will & Emery
Wilson Wan has extensive experience in the areas of general corporate issues, compliance, dispute resolution, labor and other areas. For general corporate practice, he advises foreign and domestic companies in a wide range of issues.
www.pharmacompliance-china.com
IBC Asia’s 3rd Pharmaceutical Compliance Forum remains the ONLY gathering for compliance professionals in Pharma. The meeting is an opportunity for industry and authorities to discuss the latest developments, best practice and risk management with a view towards the future.
This 2017, the 2nd Annual Pharmaceutical Congress China, part of IBC’s PharmaCon Series will co-locate 3 events; 3rd Pharmaceutical Compliance, Patient Centric Clinical Trials, and Clinical Trials Site Selection & Quality. From addressing pharmaceutical compliance challenges and issues, driving clinical operation efficiencies and discovering new clinical design technologies, to clinical trials site selection and quality assurance, PharmaCon China 2017 promises to cover in-depth issues pertaining to compliance and clinical trials in China’s pharmaceutical industry.
“GOOD CROSS SECTION OF INDUSTRY MEMBERS PRESENT”Managing Director, Compliance Risk Logic
“EVERYTHING IS GOOD, SOME FRESH POINTS SHARED BY SPEAKERS FROM THEIR PERSPECTIVE”Compliance Officer, Nestle S.A
“THE CONFERENCE CONTENT WAS VERY GOOD, AND THE SPEAKERS WERE VERY KNOWLEDGEABLE. THE TOOLS AND RESOURCES SHARED ARE VERY RELEVANT FOR COMPLIANCE PRACTICE”Regional Compliance Officer, Teva Pharmaceuticals
3 CO-LOCATED EVENTS
AGENDA AT A GLANCE
Pharma Regulatory Compliance, IP & Legal
Framework
Values & Ethics
Internal Controls & Risk Management
Third Party Compliance Strategies
Alternative Anti-Bribery Schemes & Best Practices
Recruitment Strategies & Patient Selection
Patient Records: Quality & Validity
Best Practices on Informed Consent
Technologies & Other e-Clinical Trial Solution for Patients
Patient Retention, Engagement & Experience
CFDA Regulations, Quality Requirements & Sites
Sponsor-Site-CRO Relationship & Project Management in China
Evolving Roles of PI in Trials & Investigator Initiated Trials
Site Infrastructure, Capability & Shift to Electronic Systems
Patient Support & Experience: Site Perspective & Technology
DEDICATED NETWORKING
AREA FOR PHARMA
COMPLIANCE DELEGATES
CHINA’S MOST RENOWNED PHARMACEUTICAL COMPLIANCE EVENT
SPONSORSHIP & EXHIBITION OPPORTUNITIES AVAILABLE!
EXHIBITION BOOTH
Showcase your products and solutions and engage your
targeted audience through the exhibition stands or table
displays.
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Conference Rooms
Buffet
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DEDICATED NETWORKING
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DELEGATES
www.pharmacompliance-china.com
For more information about how you can leverage on our events to optimise your marketing budget, and reach your target audience, please contact: Ms. Yvonne Leong atTel: +65 6508 2489 Mobile: +65 9852 3282 Email: [email protected]
WHO SHOULD SPONSOR? • Contract Research Organisations (CROs)• IT Solution Providers: Cloud Computing, Data Management• Data Service/Integrity Companies• Staff Recruitment Providers• Laboratory Services• Translation Companies• Market Research Companies / Consultants• Audit/Law/IP Firms
WHO YOU WILL MEETPER INDUSTRY GEOGRAPHY
China, PRC/Hongkong .....60%
Taiwan ...................................... 10%
Singapore ................................ 10%
Others Asian Countries ...... 10%
Europe/Australia .................... 5%
Others ......................................... 5%
Pharma 50%
Medical Device 10%
Biotech 10%
Government/ Regulators 4%
CRO’s/CMO’s 10%
Law Firms 8%
Financial Advisors/Audting/ Forensics &
Investigations 3%
Risk Management & Consultants 3%
Life Sciences, Data Analytics & Service
Providers 2%
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