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

19 – 20 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

Snapshot of 2018 Attendee List:

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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

8:55 am

Chairperson’s Opening Remarks

Danny Soon, Senior Director, Health and Biomedical Cluster, Biomedical Research Council (BMRC) A*STAR

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.

9:30 am

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

Kurt Scheinpflug, Senior Director of Digital Medicines Engineering, Proteus Digital Health, USA

10:00 am

10:40 am

Morning Networking & Refreshment Break

GLOBAL REGULATORY AFFAIRS UPDATES

11:10 am

Chairperson’s Opening Remarks

Shun Jin, Head, Regulatory Affairs, APMA, Sandoz, Singapore

11:20 am

GLOBAL REGULATORY AFFAIRS UPDATES

11:50 am

  • Encouraging innovation and research with greater efficiency, consistency, and transparency through the new regulation
  • Uniform framework established for the authorization of clinical trials with a single assessment outcome
  • Online portal for the submission, authorization and supervision of applications through a single entry point

12:25 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

2:40 pm

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

3:05 pm

  • Overview of Biologic Product Registration
  • Recent developments in Malaysia’s regulatory landscape
  • Updates on NPRA’s CGTP registration & variation guidelines for biologics
  • Regulatory challenges & way forward

3:30 pm

Afternoon Networking & Refreshment Break

4:00 pm

  • Updated drug registration guideline
  • Approval process and timelines
  • Integrated system of pharmaceuticals management

4:30 pm

  • Generics and OTC drug regulation in Southeast Asia, uneven
  • Compliant regulation varied from different international and national, ICH, WHO standards
  • Challenges in dossier submission and technical variation for regulators
  • How to apply compendial standards in this application to help regulators and industry players

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

9:00 am

  • Developments in pharma regulatory affairs in Asia against a global outlook, and how it will impact future launch environments
  • Strategies and best practices for navigating evolving, complex regulatory environments
  • Pain points and drivers of launch excellence and ensuring market adaptability, flexibility

9:40 pm

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

10:10 am

  • Current regulatory landscape and structure – a high-level overview of the most recent regulatory changes in China
  • The impacts of its regulatory reform
  • IND application procedures and streamlining of clinical trial administration
  • Fast-tracking of drug approvals and updated review processes

10:40 am

Morning Networking & Refreshment Break

11:00 am

  • Coping with the increasing complexity and challenges of developing new products for the global competitive markets
  • A business transformation approach to manage products and related information across the enterprise
  • Product lifecycle Management has helped pharmaceutical organizations with the ability to:
    • Increase their ability to get products to market quicker,
    • Ensure greater regulatory compliance and
    • Efficiencies while reducing development costs

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

REGULATORY COMPLIANCE & POST-APPROVAL CONSIDERATIONS

12:00 pm

  • How can digitalisation and connected world play the part in monitoring better patient outcomes, drug performance and market dynamics of approved drugs?
  • Limitations of scope for mobile applications and implications on patient leaflet designs
  • The future of adverse effects monitoring and use cases

12:30 pm

Networking Lunch and VIP Tables

1:30 pm

  • Uptake and progress on drug e-labelling initiatives across US, EU, Japan and Asia
  • 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?

2:10 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

2:50 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

3:30 pm

Afternoon Networking & Refreshment Break

PHARMACON ASIA 2018 CLOSING PLENARY SESSIONS

4:10 pm

5:00 pm

Chairperson’s Summary and End of Conference

pricing

Packages Price
2 Day ConferenceSGD $2895Early 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.
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 >>

Partners

View Partners profile >>

speakers

Danny Soon

Senior Director, Health and Biomedical Cluster, Biomedical Research Council (BMRC) A*STAR

Ho Weng Si

Director, Biomedical Sciences Group, Economic Development Board, Singapore

Kurt Scheinpflug

Senior Director of Digital Medicines Engineering, Proteus Digital Health, USA

Enver Erkan

Country Manager, Pfizer Singapore

Alexis Serlin

Asia Cluster Head, Novartis

Miguel Rivera

Global Digital Innovation Lead, Ferring Pharmaceuticals, Switzerland

How Ti-Hwei

Country President, AstraZeneca, Singapore

Shun Jin

Head, Regulatory Affairs, APMA, Sandoz, Singapore

Finny Liu

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

Hye Jin Choi

Principal, Strategic Clinical Development Consulting Asia Pacific, IQVIA, South Korea

Bruce Sun

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

Silke Nolkemper

General Manager, Director Consulting APAC, EXTEDO, China

Cindy Huang

Senior Technical Specialist, Division of Medicinal Products, Taiwan Food & Drug Administration, Taiwan

Chua Hui Ming

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

Theingi Zin

Director (Drug Control), Food & Drug Administration, Ministry of Health & Sports, Myanmar

Sherry Wang

Associate Director, Public Policy & Regulatory Affairs - Southeast Asia, Global External Affairs, United States Pharmacopeia (USP), Singapore

Koichi Miyazaki

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

Catherine Clemente

Associate Drug Regulatory Affairs & Pharmacovigilance Lead, Sandoz, Philippines

Lu Bihong

Head, Regulatory Affairs APAC, UCB Pharmaceuticals, China

May Wei

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

Anuradha Arunachalam

Regulatory Affairs and Pharmacovigilance Specialist, Novo Nordisk, Singapore

Jean-Christophe Delumeau

Head of Pharmacovigilance Policy Strategy, Bayer, Singapore

Rie Matsui

Director, Regional Labeling Head for Asia, Pfizer, Japan

Yeo Jing Ping

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

Manoj Saxena

Director Regional Market Access, Asia-Pacific, Bayer, Singapore

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

Harish Dave

Co-Founder and Chief Medical Officer, Aum Biosciences, Singapore

when & where

19 - 20 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

Get Directions
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contact

Still have a question?

Customer Service
register@ibcasia.com.sg
+65 6508 2401

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

Gold Sponsor Panel Sponsor

exhibitors

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