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

www.pharmacompliance-china.com

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

NEL

DIS

CU

SSIO

N

PAN

EL D

ISC

USS

ION

“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 yvonne.leong@ibcasia.com.sg

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

PAN

EL D

ISC

USS

ION

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.

VIP2

VIP3

VIP8

VIP7

VIP1

VIP4

VIP5

VIP6

Lucky Draw

Conference Rooms

Buffet

Buffet

Buffet

WiFi Booth

DEDICATED NETWORKING

AREA FOR PHARMA COMPLIANCE

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: Yvonne.Leong@ibcasia.com.sg

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%

1

2

3

4 1

2

3

45

6

7

8