www.pharmaregulatoryasia.com

IBCLIFE SCIENCES

PART OF

CO-LOCATED WITH:PRODUCED BY: BRONZE SPONSORS:

45+Expert Insights

200+Total Participants

Milan Paleja Country President and General Manager Novartis, Indonesia

Anu Mahashabde Senior Director, Global Established Pharma Regulatory Strategy Pfizer, United States

Li Ling Liu Director, Good Registration Management (GRM), Researcher & Deputy Director General Minister Office, Chinese Taipei Food and Drug Administration (TFDA), Taiwan

Eva Kopecna Senior Director Generics Regulatory Affairs Global OTC Teva Pharmaceuticals International GmbH, Switzerland

Dr. Akshaya S. Odak Head - Regulatory (Biotech) LUPIN, India

May (Chunfang) Wei Vice President, Head of Regulatory, CMC and Production Moleac

Vicky HAN Senior Director Regulatory Policy Group Lead for Asia Pacific, GRA Jansen Pharma, Singapore

Jack Wong Head of Regulatory Affairs – Life Sciences, APAC, Baxter Healthcare (Asia) Secretary, Asia Regulatory Professional Association (ARPA)

Qing Xi Senior Director, Government Affairs, Market Access & Communications Pfizer, China

Claire Chin Associate Director, Regulatory Affairs, SEA & APAC Hub Allergan, Singapore

KH Tan Country Head of Legal & Compliance Novartis, Malaysia

Rakesh Chaurasia Head-Regulatory Affairs PT. Dexa-Medica, Indonesia

Dr. Asmaa Asim Head of Regulatory Affairs ROPU South East Asia & South Korea (SEASK) Boehringer Ingelheim, Singapore

Dr. Merricc Edgar-Hughes, Country Head of Regulatory Affairs ANZ, Pharmaceutical and Consumer Health, Bayer, Australia

Rie Matsui Director, Regional Labeling Head of Asia Pfizer Japan Inc

FEATURING TOP REGULATORS AND PHARMA LEADERS

3Co Located Conferences

19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore

KEYNOTE: John Wilbanks Chief Commons Officer, Sage Bionetworks, Senior Fellow, Ewing Marion Kauffman Foundation and FasterCures, USA, TEDGlobal 2012 Speaker on “Let’s Pool Our Medical Data”

19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore

TEAM

REGISTRATION

BENEFITS!

SEE REGISTRATION

PAGE FOR DETAILS.

19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore20 - 21 September 2017 • One Farrer Hotel & Spa, Singapore

www.pharmaregulatoryasia.com

WEDNESDAY 20 SEPTEMBER, 2017CONFERENCE DAY ONE

8:00 Main Conference Registration Opens & Morning Coffee

9:00 Chairperson’s Opening Remarks

PHARMACON PLENARY – INDUSTRY THOUGHT LEADERSHIP

9:10 KEYNOTE: From Trials to Table – The Move Towards a More Patient-Centric Approach John Wilbanks Chief Commons Officer, Sage Bionetworks, Senior Fellow, Ewing Marion Kauffman, Foundation and FasterCures, USA, TEDGlobal 2012 Speaker on “Let’s Pool Our Medical Data”

John Wilbanks seeks to transform and innovate medical research by accelerating data sharing between clinical studies. As the Chief Commons Officer at Sage Bionetworks, he is in-charge of figuring out how to design policies and technologies that allow health and biological data to be broadly share between patients, clinicians and data analysis.

Sage Bionetworks has put their open source toolkit innovation to the test by designing an application to conduct a set of Sage Bionetworks mobile research studies enrolling more than 100,000 participants in less than two years and integrated into more than 25 studies outside of Sage, including the US Precision Medicine Initiative.

To view John’s talk at TEDGlobal 2012, click here

9:40 Drug Development, Pricing and Access – bringing together the technical, regulatory and economic considerations

• Patient centric drug development and access• ROI drivers, and outlook for the clinical research and drug development market• Regulatory priorities across the pharma value chain• Drug pricing developments• Regulatory updates - harmonization, new policy, clarity and speed in

licensing, submission and approval • What are drug development ROIs looking like, and new partnership

models for better harnessing ROIsPanellists:Milan Paleja, Country President and General Manager, Novartis, IndonesiaLi Ling Liu, Director, Good Registration Management (GRM), Researcher, Deputy Director General Minister Office, Chinese Taipei Food and Drug Administration (TFDA), TaiwanEva Kopecna, Senior Director Generics Regulatory Affairs Global OTC, Teva Pharmaceuticals International GmbH, Switzerland Qing Xi, Senior Director, Government Affairs, Market Access & Communications, Pfizer, China Jean-François Baladi, Senior Executive Director, Health Economics and Market Access, Novartis Pharma K.K., Japan

10:30 Close of Opening Plenary followed by Morning Tea

10TH ANNUAL PHARMACEUTICAL REGULATORY AFFAIRS ASIA CONFERENCE COMMENCES

REGIONAL GOVERNMENTS KEY REGULATORY ISSUES UPDATE

11:20 Regulatory Priorities and New Initiatives • Areas earmarked for collaboration on harmonisation • Plans for reducing drug approval timelines and back logs• Regulations on trial guidelines, devices, safety, approval and market access • Noncompliance trends and how industry can improve

Panellists:Li Ling Liu, Director, Good Registration Management (GRM), Researcher, Deputy Director General Minister Office, Chinese Taipei Food and Drug Administration (TFDA), TaiwanMore Regulators to be Confirmed

12:00 Regulatory Update on Good Registration Management (GRM): Recent Trend of Pharmaceutical Regulations – A Snapshot of Good Registration Management (GRM)

• Taiwan’s current pharmaceutical regulation policies and what future holds • Update on promotion of Good Registration Management (GRP and GSP)

in APEC• Case study: GRM Pilot CoE workshop: Reviewers training• Good Submission Practice Guideline for Applicants • Government’s initiatives in pharmaceutical industry

Li Ling Liu, Director, Good Registration Management (GRM), Researcher, Deputy Director General Minister Office, Chinese Taipei Food and Drug Administration (TFDA), Taiwan

12:30 Networking Lunch

13:30 Indonesia’s NADFC Perspective on Establishing Bio Product Facility – A Focus on GMP Requirements

• Current regulations on establishment of bioproduct facilities in Indonesia• GMP requirements - does it has specific requirements for biosimilar? • Working with Government for successful implementation

HARMONIZATION AND COMPLIANCE

14:00 Effective Regulatory Compliance strategies, and a wish list for Government intervention

• Current priorities in regulatory compliance • Key areas of noncompliance, and frameworks to manage them • Harmonisation – the main areas of challenge • How is Pharma working around this?• Expectations from Government

Panellists: Vicky HAN, Senior Director, Regulatory Policy Group Lead for Asia Pacific, GRA, Jansen Pharma SingaporeRakesh Chaurasia, Head-Regulatory Affairs, PT. Dexa - Medica, Indonesia Jack Wong, Head of Regulatory Affairs – Life Sciences, APAC, Baxter Healthcare (Asia) Pte. Ltd. Secretary of Asia Regulatory Professional Association (ARPA)

14:40 Pfizer’s Case Study Patient Information Leaflet and Labeling Trends in Asia – How does Regulation view it?

• Update on patient leaflet and labeling in market• What is the possibility that patient labeling will be required in more

markets in Asia, and regulations surrounding it? • Preparing lay terms - challenge and solutions • Labeling regulations changes, what more can industry expect?

Rie Matsui, Director, Regional Labeling Head of Asia, Pfizer Japan Inc.Anu Mahashabde, Senior Director, Global Established Pharma Regulatory Strategy, Pfizer, United States

15:00 Avoiding Labelling Misprints: The Truth Behind the Labelling Review ProcessDr. Jutta Hohenhoerst, Senior Account Manager, Schlafender Hase GmbH, Germany

15:30 Afternoon Networking & Refreshment Break

APPROVALS, SUBMISSION AND REGISTRATION

16:00 Accelerated Approval Pathways – Opportunities and Challenges

• New collaborative approaches to testing the efficacy and effectiveness of new improved medicines

• Early patient access to innovative therapies that address unmet medical need

• Impact of accelerated regulatory pathways on drug development and regulatory review process

• Accelerated approval pathways in AsiaDr. Asmaa Asim, Head of Regulatory Affairs, ROPU South East Asia & South Korea (SEASK), Boehringer Ingelheim Singapore Pte. Ltd

16:30 eCTD and RPS – Worldwide Progress in eSubmissions• Status update of eCTD implementation worldwide with focus on Asia

Pacific• Wrap-up of eCTD Best Practice on Industry and Agency site• Implementation status of upcoming new standard RPS

Dr. Silke Nolkemper, Director Consulting APAC ,Regulatory Affairs Specialist / Pharmacist, EXTEDO GmbH, Germany

17:00 Moderated Q&A session with Heads of Regulatory Affairs Registration, Submission and Approval – What next? Eva Kopecna, Senior Director Generics Regulatory Affairs Global OTC, Teva Pharmaceuticals International GmbH, SwitzerlandVicky HAN, Senior Director, Regulatory Policy Group Lead for Asia Pacific, GRA, Jansen Pharma SingaporeDr. Asmaa Asim, Head of Regulatory Affairs, ROPU South East Asia & South Korea (SEASK), Boehringer Ingelheim

17:30 Chairperson’s Summary and End of Conference Day One

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www.pharmaregulatoryasia.com

THURSDAY 21 SEPTEMBER, 2017CONFERENCE DAY TWO

9:00 Chairperson’s Opening RemarksDr Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars, Germany

GLOBAL REGULATORY DEVELOPMENTS

9:10 US, EU and APAC: Global Regulatory Emerging Hot Topics and Registration Expedited Pathways

• 4 Expedited Pathways in US • Adaptive pathways and PRIME in EU• Sakigake in Japan • Priority review in China• Emerging initiatives in other AP markets: Breakthrough designation in

Korea, Expedited Pathway for Prescription Medicine in Australia etc.

Vicky HAN, Senior Director, Regulatory Policy Group Lead for Asia Pacific, GRA, Jansen Pharma Singapore

9:40 Pharmacovigilance Regulations in Europe and Australia• Risk Evaluation and Mitigation Strategy (REMS) vs Risk Minimization Plan

(RMP),• Periodic Safety Update • Reports (PSUR) Submissions, and other updates• How what we do in Australia affects Asia

Dr. Merricc Edgar-Hughes, Country Head of Regulatory Affairs ANZ, Pharmaceutical and Consumer Health, Bayer, Australia

10:10 Periodic Safety Update Report (PSUR) and Its Submission Requirements – A Shift in Paradigm

• Broadening of PSUR scope by ICH • EU process evolution: Making PSUR a tool for holistic view of the B/R

- Impact to the industry- Impact to the health authority/ Assessor- Impact to the prescribes and patients

• PSUR submission requirements of Ex-EU countries including Asian countries.- What has been accepted so far by Ex EU countries for harmonization of

region wise PSUR- Scope of further harmonization of PSUR; region wise, MAH wise, MAH

internal process wise

Sutirtha Roy, Global Program Regulatory Manager, Novartis Healthcare

10:40 Morning Networking & Refreshment Break

11:10 Learning from the Medical Device Industry Latest Update on Medical Device Regulatory in Asia

• Challenges in obtaining medical device product approvals from authorities • Developing a product that meets authority’s requirement• Launching the products in Asia – meeting regulatory and compliance

requirements

Jack Wong, Head of Regulatory Affairs – Life Sciences, APAC, Baxter Healthcare (Asia) Pte. Ltd. Secretary of Asia Regulatory Professional Association (ARPA)

CHINA AND INDIA

11:40 China Market Highlight: Reducing the Backlog of Clinical Trial and Marketing Applications – Clinical Trial Application (CTA) Process and Its Timeline

• A snapshot on China’s current regulatory landscape - approval, licensing, requirements

• Insights on China’s time line on clinical trials process of attaining approval • Trial case studies • Key regulatory takeaways for China market

May (Chunfang) Wei, Vice President, Head of Regulatory, CMC and Production, Moleac

12:10 Networking Lunch

13:10 Lupin’s Case Study: Regulatory Strategies for Biosimilars Development and Regulatory Requirements in India

• Update of current regulatory requirement from Central Drugs Standard Control Organization (CDSCSO)

• Criteria for evaluating the safety, efficacy, and quality of Biologic (SB)/biosimilar

• Lupin’s case study on biosimilars regulatory approval pathways• Pipeline of biosimilars focused products on regulated markets

Dr. Akshaya S. Odak, Head - Regulatory (Biotech), Lupin Limited, India

REGULATORY STRATEGIES FOR OTC PRODUCTS

13:40 Global Perspective on OTC Product Registration, License, Compliance, Safety and Risk Control

• Global OTC regulatory strategies - what determines the success? • Maintenance & Compliance of OTC products – Expectations & Challenges• Safety and risk management of OTC products• Key challenges during acquisition of OTC products

Eva Kopecna, Senior Director Generics Regulatory Affairs Global OTC, TevaPharmaceuticals International GmbH, Switzerland

14:10 Specific Registration and Regulatory Requirement in Myanmar for Pharma Products and Medical Devices

• Food supplements under OTC• Over-The-Counter Medicines• Prescription Only Medicines and Controlled drugs• Medical Devices

San San Win, Regulatory Affairs Manager, Sanofi Myanmar Co., Ltd

14:40 Indonesia Case Study: Specific Requirement for OTC and Prescription Products Registration in Indonesia

• Classification of Medicine• Regulations for Pharmaceutical Sector• Real Experience on Dealing with Indonesian Regulatory Authorities

Rakesh Chaurasia, Head-Regulatory Affairs, PT. Dexa - Medica, Indonesia

15:10 Afternoon Networking & Refreshment Break

THE NEW PHARMA ECONOMY

15:40 Knowing and Mitigating Legal Risk in Digital Applications for Pharma

• How are digital applications disrupting legal and regulatory landscape?• What regulatory affairs managers need to know?• How pharmaceutical companies to stay ahead of these changes?• Legal risks in highlights• Mitigation factors in the age of digital revolution in pharma industry

KH Tan, Country Head of Legal & Compliance, Novartis, Malaysia

16:10 Regulatory Developments to Support the Digitization of Pharma

• Understanding the drivers of risk and complexity of legal issues when digitization occurs

• Digital content risk in pharma industry• Potential opportunities and pitfalls• Case study

16:40 Chairperson’s Summary of the Day and End of Conference

WHAT PAST ATTENDEES SAID!

“THIS WAS A FANTASTIC GATHERING AND A VERY WELL ORGANIZED EVENT. WOULD LOVE TO ATTEND THIS IN THE

FUTURE. KEEP UP THE GOOD WORK”RAHUL MONGIA, RESEARCH ASSOCIATE, ICRIER

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19 SEPTEMBER 22 SEPTEMBERPRE-CONFERENCE WORKSHOP POST-CONFERENCE WORKSHOP

9am-5pmInterpretation of Guidelines for Drug Registration through ASEAN Common Technical Document (CTD)The differing regulatory requirements across Asia are often seen as one of the key hurdles in drug development. This spans from clinical and CMC requirements through to dossier format and mode of submission. While many countries accept ICH CTD, some prefer ACTD (ASEAN CTD) and others have a string of country-specific documents to be completed. Despite the general topics covered in CTD being similar or common, there are differences in country interpretation of guidelines and the level of information required. This means the need to develop country-specific dossiers.

This workshop aims to encourage participants to share their experience in dossier preparation and serve as a good learning exchange platform to share best practices.

WORKSHOP LEADER:Claire Chin, Associate Director, Regulatory Affairs, SEA & APAC Hub, Allergan SingaporeClaire Chin holds a Master of Pharmacy from UCL School of Pharmacy, University of London. With more

than 12 years of experience in the healthcare industry in Asia and Europe, Claire has diverse global regulatory experience and supported a wide range of therapeutic areas that cover both pharmaceutical products and medical devices. Apart from regulatory affairs, she has also been instrumental in building up the pharmacovigilance function in one of her previous roles.

MEDIA PARTNERS: INTERNATIONAL MARKETING PARTNER:

TOP REASONS TO ATTEND

Regional Government

updates on new initiatives

Drug approval bottlenecks - And how to work with

regulators to optimise timelines

Key insights on product registration, submission,

pharmacovigilance, clinical regulatory

requirements to be addressed

Practical regulatory advice and

strategies for OTC drugs, biologics & biosimilars,

controlled drugs, API and medical

device

Pharmacovigilance Regulations - REMS vs RMP,

PSUR Submissions, and other updates

New pharma economy address

on digital applications, and

digitization to mitigate legal risk

Country Case Studies from Pharma on

interpreting and working with local

regulations

9am-5pmAccelerating Drug Approval in Asia: Overview of Time-Frames and Drug Registration ProceduresThis interactive workshop is aimed at all professionals with an interest in regulatory affairs in the ASEAN region. The interaction will feature exchange of practical insights and experience with colleagues. The level of detail in this workshop and interactions will provide a useful extension to the main conference.

By attending this full day workshop, participants will share experience and gain:• A greater understanding of ASEAN harmonization initiatives

and level of implementation across the region• An overview of requirements for country-specific submissions:

the do’s and don’ts• Insights for planning approval timelines into your regulatory

strategy• Details about time frames, requirements essential for approval

WORKSHOP LEADER:Dr Michel Mikhail, International Expert in Regulatory Affairs, Germany

Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience in Senior roles,

with a track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical companies as well as in the Generic & Biosimilars industry.

WHO YOU WILL MEET

BY GEOGRAPHY Singapore .............................................. 45% Malaysia / Indonesia /Thailand... 15% Rest of South East Asia .....................10% North Asia ..............................................20% Australia/New Zealand ...................... 5% US/Europe ................................................ 5%

BY INDUSTRY Pharma/Biopharma/Biotech .......60% Government ........................................... 15% Medical Device ....................................10% CROs .........................................................10% Consultancies/Academia .................. 5%

WITH A 9-YEAR TRACK RECORD OF SUCCESSFULLY BRINGING TO MARKET THE LATEST DEVELOPMENTS AND INSIGHTS FROM DECISION MAKERS, THE PHARMA REGULATORY AFFAIRS SUMMIT REMAINS THE ONLY SUCH CONFERENCE IN ASIA.

Part of the PharmaCon suite of events, the conference affords you the opportunity of getting hot of the press information and networking across various pharma industry segments.

THOUGHT LEADERSHIP KEYNOTE!John Wilbanks Chief Commons Officer, Sage Bionetworks, Senior Fellow, Ewing Marion Kauffman Foundation and FasterCures, USA, TEDGlobal 2012 Speaker on “Let’s Pool Our Medical Data”

John Wilbanks seeks to transform and innovate in medical research by accelerating data sharing between clinical studies. As the Chief Commons Officer at Sage Bionetworks, he is in-charge of figuring out how to design policies and technologies that allow health and

biological data to be broadly shared between patients, clinicians, and data analysts.Sage Bionetworks has put their open source toolkit innovation to the test by designing an application to conduct a Parkinson’s disease study that aims to attract 18,000 participants, 10 times larger than the biggest study on this condition.

View John’s talk at TEDGlobal 2012 here

PARTNERSHIP OPPORTUNITIES NOW AVAILABLE!

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 at Tel: +65 6508 2489 l Email: Yvonne.Leong@ibcasia.com.sg

STRATEGIC BRANDING Profile your organisation as an industry leader and leverage on our integrated marketing campaign to extend your marketing reach.

NETWORKING FUNCTIONS Engage your captive audience at an exclusive event hosted by your organisation.

ONSITE BRANDING Reinforce your branding and seize the opportunity to enhance your brand visibility at the event.

PRODUCT SHOWCASE Showcase your products and solutions and engage your targeted audience through the exhibition stands or table displays.

Post Conference Workshop

Pre Conference Workshop

Opening Plenary Sessions

Networking Cocktails

Conference Day 1

19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore20 - 21 September 2017 • One Farrer Hotel & Spa, Singapore

Conference Day 2

19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore20 - 21 September 2017 • One Farrer Hotel & Spa, Singapore

PHARMACON ASIA AT A GLANCE

19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore 19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore