11th Annual Pharma Regulatory Affairs Summit 2018

2018年9月18-21日 • 新加坡, One Farrer Hotel & Spa


Pharma Regulatory Affairs Summit今年将迎来第11年,是以药事法规专家为对象的重要活动,可以学习有效对应亚洲各国复杂又变化剧烈的药事法规的世界各国最新信息与策略。本峰会拥有10年历史,各组织干部将发表药事法规最新趋势与重要见解。

本峰会为第5届PharmaCon Asia的一环,是个珍贵机会,可以直接与制药业界领导者与开发者见面并加深交流,透过同时举行的各种活动,学习药事法规相关最新趋势与案例研究。

"The event was beneficial in understanding new therapy areas and challenges which are beyond generic pharmaceuticals."

- Rakesh Chaurasia, Advisor, Strategic International Regulatory Affairs, PT Dexa Medica


  • 各国政府最新消息
  • 各国药物管制机关准则和构想的最新信息
  • eCTD、药事信息管理 (RIM) ISO IDMP 标准的实用性
  • 药品外包市场和法规面的具体要求条件
  • 成功地完成了快速审批过程的案例分析
  • 关于调整亚洲区域医疗设备和医药产品条例的最新信息
  • 上市后调查的要求条件
  • 数据的可靠性, 隐私和信息管理的最佳实践
  • 从研究开发到市场行销的各个阶段的一般法规问题。


2nd Annual Accelerating Clinical Trials in Asia 2018 >>
2nd Annual Pharma Market Access and Pricing Summit Asia >>


8:00 am

Registration Starts & Morning Coffee

8:55 am

Chairperson's Opening Remarks


9:00 am

[Industry Address] Future of Pharma - Adapting Business Models in the Age of Analytics, Data Sciences and Machine Learning

9:30 am

[Innovation Talk] Innovation and Digitalisation - The Impact and Where Do We Go Next?

Dan Wang, Head, Johnson & Johnson Innovation Asia-Pacific, China

10:00 am

  • Drug pipeline growth areas
  • Regulatory trends
  • Innovation in pricing and market access
  • The most significant industry trends in the long term, and how should Pharma respond

10:40 am

Morning Networking & Refreshment Break


11:50 am

  • Global eCTD adoption status, trends, eCTD 4.0
  • e-Acceleration in emerging markets and China's eCTD transition
  • Use cases for AI, technological solutions in regulatory submissions, publishing, and accelerating drug development

12:30 pm

  • Pharma-AI new "Eco-system"
  • Use Cases in Regulatory Operations (esp. eCTD)
  • Future Regulatory Operation Model

1:00 pm

Networking Lunch and VIP Tables


2:00 pm

  • GMP guidelines and updates
  • Overview and case studies for expedited approval timelines and procedures
  • Frequently-asked questions and regulatory pain points

2:30 pm

  • Recent developments in Malaysia's regulatory landscape
  • Updates on NPRA's CGTP registration & variation guidelines for biologics
  • Regulatory pain points and commonly-encountered challenges in drug approval processes

3:00 pm

  • Recent developments in Malaysia's regulatory landscape
  • Updates on NPRA's CGTP registration & variation guidelines for biologics
  • Regulatory pain points and commonly-encountered challenges in drug approval processes

3:30 pm

Afternoon Networking & Refreshment Break

4:00 pm

  • Recent developments in Vietnam's regulatory landscape
  • New drug registration guideline and overview of approval process
  • Labelling requirements - updates, expectations

4:30 pm

  • Post-marketing considerations and differences across biologics, vaccines and generics in Philippines
  • Pharmacovigilance and RMP submission requirements in lieu of vaccines post-marketing surveillance
  • ASEAN Common Technical Document (ACTD) requirements in safety studies, in line with ICH standards

5:00 pm

Chairperson's Summary & End of Main Conference Day One

8:30 am

Morning Coffee

8:55 am

Chairperson's Opening Remarks


9:40 pm

  • Regulatory Environment of Asia Pacific
  • FDA and EMA opinions
  • Challenges and opportunity on Botanical Drug Development

10:10 am

  • What are the considerations and influences on intellectual property protection with the rise of internationalisation, harmonisation and digitalisation?
  • Emerging approaches for IP strategies and its regulatory implications

10:40 am

Morning Networking & Refreshment Break

11:00 am

  • Eliminate silos to develop a proactive cross-functionally interacting team leading to integration of functional expertise and business goals
  • Practice timely and effective communication for a successful cross-functional integration
  • Leverage cross-functional expertise to strengthen relationships with regulatory agencies

11:30 am

  • Impacts of ICH E17 and considerations for regulatory decision-making in the evolving landscape of clinical development
  • GCP inspections and local expectations across Asia
  • Best practices and industry perspectives on meeting different requirements

12:00 pm

  • Current challenges in information management
  • Moving from regulatory intelligence to actionable insights and competitive regulatory strategies
  • Use cases of implementations in the region
  • Emerging trends - use of artificial intelligence in enhancing regulatory intelligence efficiencies

12:30 pm

Networking Lunch and VIP Tables


1:30 pm

  • Updates on EMA's GVP guidelines, EudraVigilance system
  • Aligning current practices to new safety and efficacy guidelines for ATMP

2:00 pm

  • Challenges in compliance will be discussed
  • The importance of QMS and key elements will be reviewed.
  • The practical steps in ensuring quality and compliance to ICH GCP E6(R2) and Singapore Human Biomedical Research Act will be discussed

2:30 pm

  • GMP guidelines in Asia - what to expect, and what are the key differences
  • Quality, lifecycle management

3:00 pm

  • Uptake and progress on drug e-labelling initiatives in EU, US, Japan
  • What are the risks, concerns, and key considerations for implementation in Asia and what are its impacts?
  • How can regulatory affairs support the adoption of electronic labelling?

3:30 pm

Afternoon Networking & Refreshment Break


5:00 pm

Chairperson's Summary and End of Conference

9:00 pm

ICH CTD/eCTD is global regulatory submission standard which has been implemented for many years in majority of developed pharmaceutical markets but was still new to the emerging markets especially for APAC region. With recent regulatory landscape changes, more and more APAC countries are transitioning their policy or guidelines to make full alignment with ICH standards to implement either CTD or eCTD (i.e., Australia, Thailand, Korea, Singapore and China). The IBC Asia will invite Pfizer experts of CTD/eCTD to introduce the regulatory requirements of CTD/eCTD, how to interpret eCTD specification, and share successful cases in eCTD submission/pilot for Thailand/China.


  • The Structure and Format of CTD/eCTD (30 min)
  • Management of eCTD Life Cycle (30 min)
  • Overview of eCTD Specifications (30 min)
  • Global eCTD Transition and Case Study (30 min)
  • China eCTD implementation Update (30 min)
  • Panel discussion (30 min)

1:00 pm

End of workshop

9:00 pm

Quality and uninterrupted access are key objectives in managing post-approval changes. How can regulatory affairs professionals continue to ensure regulatory flexibility and enforcement discretion while managing post-approval activities? This interactive workshop aims to provide participants with a better understanding of how to formulate regulatory strategies with key CMC and lifecycle management considerations in mind.

Key Takeaways:

  • Get up to speed on global regulatory updates on Lifecycle Management and GMP Compliance Standards
  • Overview of primary causes of drug shortages & global challenges
  • Dealing with post-approval changes according to ICH Q12
  • Regulatory strategies for managing post-approval changes and uninterrupted access

1:00 pm

End of workshop


参加成为Pharma Regulatory Affairs Summit的夥伴,可提高知名度。


Dan Wang

Head, Johnson & Johnson Innovation Asia-Pacific, China

Enver Erkan

Country Manager, Pfizer Singapore

Alexis Sterlin

Asia Cluster Head, Novartis

Rajkumar Narayanan

President Asia, Alcon

Finny Liu

Lead of APAC Regional Regulatory Policy, PDR, Roche, Singapore

Silke Nolkemper

General Manager, Director Consulting APAC, EXTEDO, China

Bruce Sun

Publishing Team Lead (Established Markets), Worldwide Regulatory Operations, Pfizer, China

Chyn-Liang (Cindy) Huang

Section Chief, Division of Medicinal Products, Taiwan Food & Drug Administration, Taiwan

Senior Representative, IQVIA

Chua Hui Ming

Senior Principal Assistant Director, Biologics Section, Center for Product Registration, National Pharmaceutical Regulatory Division (NPRA), Ministry of Health Malaysia

Catherine Clemente

Associate Drug Regulatory Affairs & Pharmacovigilance Lead, Sandoz, Philippines

James Cai

Vice President, Global Regulatory Affairs, Value, Access & Policy, Amgen, China

Shweta Uppal

Director, Clinical, Medical, Regulatory, Quality & Pharmacovigilance (Singapore, Malaysia, Brunei), Novo Nordisk, Malaysia

Koichi Miyazaki

Senior Director, Clinical Development Group, Asia Development Department, R&D Division, Daiichi Sankyo, Japan

May Wei

Vice President, Head of Regulatory, CMC & Production, Moleac, Singapore

Yoshihito Daimon*

Director, IP Legal, Mylan Seiyaku, Japan

Lu Bihong

Head, Regulatory Affairs APAC, UCB Pharmaceuticals, China

Senior Representative from Eli Lilly & Company

Yeo Jing Ping

Director of Research Integrity, Compliance & Ethics, SingHealth, Singapore

Koo Siang Chueng

Director, Regulatory Compliance, Johnson & Johnson, Singapore

Rie Matsui

Director, Regional Labeling Head for Asia, Pfizer, Japan

Hazel Dy Tioco

Asia Pacific Regional Director, Study Management and Logistics, Sanofi, Philippines

Yaron Turpaz

Chief Data & Technology Officer, Managing Director, Global Gene Corp, Singapore

Shazli Ahmed Khan

Head, Business Development & Licensing (Asia Cluster), Novartis, Singapore (invited)

Handsome Ji

APAC Publishing Lead, Worldwide Regulatory Operations, Pfizer, China



新加坡, One Farrer Hotel & Spa
1 Farrer Park Station Road
Singapore 217562

Contact Person: Daniel Koh
DDI: (+65) 6705 7884
Fax: (+65) 6834 7892
Cell: (+65) 86870123
Email: danielkoh@onefarrer.com


Media Partners

APBN serves as a knowledge exchange platform (print and online) to provide latest news and noteworthy information in biotechnology, healthcare, biomedical and pharmaceutical industry in Asia Pacific. Established in 1997, APBN is the first and only monthly magazine focused on biotechnology, healthcare, pharmaceutical and life science developments in China and other Asia Pacific countries. The main motivation of APBN is to bring biotechnology news in a comprehensive and concise manner to, but not limited to, clinicians, research scientists, students, and other industry professionals and experts.

Bentham Science Publishers is rendering a vital service in the quality publication that publishes over 100 peer-reviewed print and online scientific, technical and medical journals. These titles are indexed in recognized indexing agencies, such as Science Citation Index®, Journal Citation Reports/Science Edition, MEDLINE/Index Medicus, PubMed, Scopus, Chemical Abstracts, EMBASE etc. Some of the high impact titles which enjoy a wide reach and distribution are Current Gene Therapy (Impact Factor 4.906), Current Alzheimer Research (Impact Factor 3.796), Current Medicinal Chemistry (Impact Factor 3.715), and other popular titles.

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BiotechEast provides information and services related to Taiwan's growing life science industries. Our services cover a wide scope, including marketing and business intelligence, investment sourcing, and partner identification and vetting. Founded in 2003, our mission is connecting Taiwan and overseas companies within this industry space, for the advancement of medical technology and the benefit of patients everywhere.

KONGPOSH Publications is one of the leading Pharma publishers of India. Our publications are - The Pharma Review® is a bi-monthly article based journal. Covering news, views and articles on various fields of pharmacy including Clinical Trials, Biotechnology, Review/Research papers, Herbal Medicine and much more. Contributions received from Eminent pharma personalities from India as well as other countries which helps us to have a varied and rich content matter. Participation and distribution in over 20 Expos & Conferences worldwide each year. It is widely read by decision makers, middle management and the academia. The journal is Abstracted & Indexed in International Pharmaceutical Abstract & Chemical Abstract - USA, Index Copernicus - Poland & Ulrich's Journal Database- USA for the quality of its content. Also available on our website and E-book format.

For regular complimentary link of the journal write to us on kongposhpub@gmail.com.


SOURCE newswire provides comprehensive coverage of breaking news for the life sciences industry in China. Daily updates allow timely tracking of key company developments, deal-making, and regulatory trends, with the primary focus on the pharmaceutical industry.

  • Daily News Briefs: receive 3-4 original articles each day
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  • Access a fully searchable archive of 20,940 original articles
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Lingmed Ltd was founded in 2013 in Hong Kong, currently we have offices in Shanghai and Beijing. Lingmed promotes three leading intelligence databases for healthcare professionals in China to make better decisions. Lingmed’s core products are healthcare intelligence databases; it covers global innovative assets & China market intelligence. Lingmed’s Products and Services have been recognized by Fortune 500 multinational pharma and device companies as well as Chinese local big pharmacos. In addition, we together with our partners in Europe provide partnering services to bridge European and Chinese pharmaceuticals with biotech companies, including valuation and market monitoring reports.

In the realm of Pharmacy, where innovation is rapid, Pharmaceutical-Tech stands adept at conceptualizing unique ideas relevant to the B2B space. Pharmaceutical-Tech is essentially a B2B online business, technology media platform and global magazine that have under its wraps the largest global database of Pharmacy buyers and suppliers. Pharmaceutical-Tech.com covers in-depth trends that shape industry dynamics and metamorphose global economics. With services like search engine optimization, global magazine, social media marketing, product video showcase, e-mail marketing, e-newsletter sponsorship, banner advertising, event marketing and micro-website within our platform, www.pharmaceutical-tech.com has created a recognition that spans over a global audience, thereby revolutionizing how businesses transact.

Pharma China (www.pharmachinaonline.com) is the most trusted English media and business intelligence service covering the Chinese pharmaceutical / biopharmaceutical industry and market.

Pharma China caters for the growing needs of the international pharmaceutical industry for up-to-date and insightful information and intelligence on China's burgeoning but increasingly complex healthcare marketplace, and is subscribed by most multinational pharmaceutical companies, leading CROs, investment banks and consulting firms active in China as well as relevant industry associations and government agencies.

  • Pharma China Journal Edition (monthly in PDF and Print)
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  • China Pharmaceutical Guide (the most comprehensive and authoritative reference for China's healthcare sector)

Pharma Focus Asia is a quarterly magazine from Ochre Media Pvt. Ltd. Pharma Focus Asia covers important issues and trends shaping the future of the Pharma industry across Asia and rest of the world. It is the leading Pharma title in print as well as digital versions serving the information needs of key executives from the world's leading pharmaceutical companies.

Informa's Pharma Intelligence is the trusted partner of the top 50 global pharmaceutical companies and the top 10 contract research organisations (CRO's) – providing timely intelligence and insight to help them make authoritative decisions.

From drug and device discovery and development to regulatory approval, drug reimbursement to lifecycle management – we provide the global intelligence and insight to help advance our partners' initiatives in a fast changing market.

Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide.

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