11th Annual Pharma Regulatory Affairs Summit 2018

2018年9月18-21日 • シンガポール、One Farrer Hotel & Spa


今度で11年目を迎えるPharma Regulatory Affairs Summitは、薬事規制分野の専門職を対象とした重要イベントであり、アジア諸国の複雑で変化の激しい薬事規制に対応していくのに役立つ世界各国の最新情報や戦略について学ぶことができます。10年の歴史を有するこのサミットでは、さまざまな組織の幹部が薬事規制の最新動向や重要な見解を披露します。

第5回PharmaCon Asiaの一翼を担うこのサミットは、製薬業界のリーダーや開発者と直接会って交流を深めることができる貴重な機会となっており、同時併催される各種のイベントを通じて、薬事規制関連の最新動向やケーススタディを学ぶことができます。

"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


  • 各国政府の最新情報
  • 各国薬事規制機関のガイドラインや構想に関する最新情報
  • eCTD、薬事情報管理 (RIM) 、ISO IDMP規格の実用性
  • 医薬品関連のアウトソーシング市場と規制面の具体的な要求条件
  • 成功裏に行われた迅速承認手続きのケーススタディ
  • アジア地域での医薬品と医療機器に関する規制の調整に向けた取り組みについての最新情報
  • 市販後調査の要求条件
  • データの信頼性、プライバシー、情報管理のベストプラクティス
  • 研究開発からマーケティングまで各段階における規制の全般的な問題


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


8:00 am

Registration Starts & Morning Coffee


9:00 am

Addressing on skilled talent, strong manufacturing capabilities and thriving research ecosystem in pharmaceutical firms to set up to serve patients and connect with the growing Asian market.

9:20 am

[Industry Address] Integrating Silicon with Drugs: Pushing the Boundaries of Pharma Manufacturing with Digital Medicines

Nik Leist, Senior Director, Ingestible Sensor Manufacturing/Site Leader, Proteus Digital Health, USA

9:40 am

Scott is a TEDx global thought leader and bestselling author, armed with a raw enthusiasm for technology and a fascination with people. A technology & innovation guru, a global leader in the cutting edge arena known as "The Digital Shift", encompassing innovation, culture, design, and mobility in a world gone digital. As a thought leader, he thrives on the intersection between cultural and behavioural changes in the face of technology innovations.

Aspiring to transform mainstream thought processing around conventional business practices, he has spoken at at TEDx, Social Media Week, Google Think, Fund Forum, Asian Banker, Next Money and a long list of private events. His thought leadership pieces on lead market expansion and innovation capability development in have appeared in WIRED, Australian Financial Review and E27.

To listen to Scott's talk, click here

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


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

Fireside Chat with Pharma Regulators

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
  • Best practices and industry perspectives on meeting different requirements
  • Managing clinical studies and regulatory strategies following E17 implementation

12:00 pm

  • China's current regulatory landscape and structure - what's changed and what else to expect
  • IND application procedures and streamlining of clinical trial administration
  • Fast-tracking of drug approvals and updated review processes

12:30 pm

Networking Lunch


1:30 pm

  • Developments in EMA's GVP guidelines and modules, EudraVigilance monitoring
  • GVP practices in Asia, US and best practices for aligning current practices and regulatory strategies

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


Pharma Regulatory Affairs Summitにパートナーとして参加することで、知名度を高めることができます。


Ho Weng Si

Director, Biomedical Sciences Group, Economic Development Board, Singapore

Nik Leist

Senior Director, Ingestible Sensor Manufacturing/Site Leader, Proteus Digital Health, USA

Scott Bales

Managing Director - Innovation & Digital Transformation, Innovation Labs Asia

Enver Erkan

Country Manager, Pfizer Singapore

Alexis Sterlin

Asia Cluster Head, Novartis

Miguel Angel Rivera Tapia

Global Digital Innovation Lead, Ferring Pharmaceuticals, Switzerland

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



シンガポール、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.

Bentham has an extensive library of eBooks in the areas of science, technology, medicine, social sciences and humanities. Bentham eBooks publishes monographs, handbooks, conference proceedings, textbooks, review volumes, biographies and autobiographies.

Established since 1998, Bio-Equip is a leading website for lab equipments, reagents, consumables and bio services. Our users come from different fields like life science, medical research, pharmaceutical, biotechnology, modern agriculture, food safety and environment monitoring. Bio-Equip offer users a complete product directory which involves 158 product ranges among lab equipments, reagents, consumables, lab animals, bio services, cell lines, bio software and books.Serving users through two websites, www.bio-equip.com (Chinese) and www.bio-equip.cn (English), we own over 20,000 registered suppliers and more than 500,000 pieces of product and technical service information with details of product description, price, sample downloading, technical articles and videos.

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
  • Email alerts on topics of interest by keyword.
  • Access a fully searchable archive of 20,940 original articles
  • Filter news by story type: company news; product/R&D trends; pricing and reimbursement decisions; and general policy developments
  • Ability to save and share favorite news items.

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)
  • Pharma China Web Edition (continuously-updated news, in-depth commentaries and online databases)
  • 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.

Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.

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