11th Annual Pharma Regulatory Affairs Summit 2018 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, VALID UNTIL 29 JUNE 2018.
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

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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

8:55 am

Chairperson’s Opening Remarks

PHARMACON ASIA 2018 OPENING PLENARY SESSIONS

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

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 and VIP Tables

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

  • 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

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
  • 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

REGULATORY COMPLIANCE & POST-APPROVAL CONSIDERATIONS

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

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 $2895SGD $2695Early BirdEarly Bird

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, valid till 29 June 2018 only.
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

Partnership and Profile Building Opportunities are Now Available!
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.

View Sponsors and Exhibitors profile >>

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speakers

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

Thanh Nguyen Thi Hong

Head of Regulatory Affairs & Quality Management, Fresenius Kabi, Vietnam (invited)

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

May Wei

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

Yoshihito Daimon

Director, IP Legal, Mylan Seiyaku, Japan (invited)

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

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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