P46361 11th Annual Pharma Regulatory Affairs Asia 2018
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11th Annual Pharma Regulatory Affairs Asia 2018

18 – 21 Sep 2018,  One Farrer Hotel & Spa, Singapore

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SPECIAL 1-FOR-1 OFFER ON NORMAL RATES FOR PHARMACEUTICAL COMPANIES*
LIMITED SEATS, APPLICABLE ONLY TO 2-DAY MAIN CONFERENCE DAYS.
SEE PRICING BELOW FOR MORE INFORMATION.

overview

The 11thAnnual Pharma Regulatory Affairs Asia is the leading platform for regulatory experts, to be updated with latest country updates and strategies to navigate the complex and ever changing regulations in the region. With a 10-year track record, IBC Asia brings to market the latest developments and key insights from decision makers.

Part of the 5th Annual PharmaCon Asia, meet and network with industry leaders and implementers, and get up-to-speed on the latest insights and case studies in pharma across 4 co-located events.

“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

Past Participating Companies

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Conference Highlights

  • Updates on the regulatory harmonization efforts in Asia for pharmaceutical drugs
  • Country-specific regulatory updates on the latest guidelines and initiatives
  • Global eCTD transition and acceleration in emerging markets and China
  • Use of AI in pharmaceutical regulatory operations
  • Enhancing launch excellence and cross-functional connections for better regulatory outcomes
  • Post-marketing surveillance requirements – best practices for compliance in managing post-approval changes, clinical research, safety
  • Global and regional outlook on drug e-labelling initiatives

Choose your language

Part of

Pharmacon Asia >>

Co-Located Events

Accelerating Clinical Trials in Asia >>
Pharma Regulatory Affairs Asia >>
Pharma Market Access and Pricing Summit Asia >>
Digital Pharma Summit >>

agenda

8:00 am

Registration Starts & Morning Coffee

PHARMACON ASIA OPENING PLENARY SESSION

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

GLOBAL REGULATORY AFFAIRS UPDATES

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

DRUG DEVELOPMENT & REGULATORY LANDSCAPES

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

REGULATORY STRATEGY & ACCESS

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

REGULATORY COMPLIANCE & POST-APPROVAL CONSIDERATIONS

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

PHARMACON ASIA 2018 CLOSING PLENARY SESSIONS

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.

Topics:

  • 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

For workshop leader opportunities, kindly contact Genevieve.Lim@ibcasia.com.sg  

1:00 pm

End of workshop

pricing

Packages Price
2 Day ConferenceSGD $2895Early Bird
Extras Price
Pre Conference Workshop SGD $800
Post Conference Workshop SGD $800

Early Bird Rate: Register & Pay by 20 July 2018

Special 1-for-1 Offer on Normal Rates for Pharmaceutical Companies*
Limited seats, applicable only to 2-day main conference days.
Email register@ibcasia.com.sg to find out more!

*The organizer reserves the right to determine the industry to which your company belongs, and to stop the promotion at any stage.

GROUP SAVINGS:
Register 2 Delegates and get 1 FREE PASS
Register 3 Delegates and get 2 FREE PASS
(Group rate is based on normal rate of 2-day main conference package only)

For Group Registrations of more than 3 team members,
email info@ibcasia.com.sg or call +65 6508 2477

  • Multiple Bookings Discount pricing is applicable to groups of 3 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies; either the early bird rate OR group rate.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • All delegates from Singapore-based companies are required to pay an additional 7% GST (SINGAPORE EVENTS ONLY)

Sponsorship

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Contact us today to find out how you can position your company as a market leader at this event, and to explore the range of branding and marketing opportunities available.

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speakers

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 Serlin

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)

Harish Dave

Chief Medical Officer, Executive Director, Aum Biosciences, Singapore

Handsome Ji

APAC Publishing Lead, Worldwide Regulatory Operations, Pfizer, China

when & where

18 - 21 Sep 2018

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

contact

Still have a question?

Speaking Opportunities
Genevieve Lim
+65-6508 2472
 
Genevieve.Lim@ibcasia.com.sg

Sponsorship Opportunities
Yvonne Leong
+65 6508 2489

Yvonne.Leong@ibcasia.com.sg

Media & Association Partnership Opportunities
June Tan
+65 6508 2465
June.Tan@ibcasia.com.sg

sponsors

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