12th Annual Pharma Regulatory Affairs Asia

Day 1 : Wed, 25 Sept 2019

0900
IBC Opening Address

0905
Chairperson’s opening remarks

Ron Kamienchick, Senior Director, Digital Health, Head of Diagnostics and Personalized Medicine, Teva Pharmaceuticals, USA

0910
Pharma Transformation Keynote Address:
Moving Pharma Closer to its Most Important Customer: How Digital Technology is Enabling Patient-Centricity?

Ron Kamienchick, Senior Director, Digital Health, Head of Diagnostics and Personalized Medicine, Teva Pharmaceuticals, USA

0940
Pharma Leadership Roundtable:
The Next Pharma Industry Priorities: Business, Technology, Regulatory Compliance and Leadership

  • Pharma landscape and evolving regulations
  • Revolutionising the pharma industry towards patient engagement
  • Capturing new revenue streams and markets
  • Leveraging on strategic partnerships and collaborations to drive growth
  • The shift towards value-based pricing
  • Embracing digital transformation – Challenges and opportunities in Asia

Moderator:
Christine Kuan, Market Access and External Affairs Director, Taiwan and Southeast Asia, Bristol-Myers Squibb, Taiwan

Panelists:
Angela Deluca, Head of Project Planning & Innovation Department, Japan Development, AbbVie, Japan
Sophia Huang, Head of Regulatory Submission Management and Planning Beijing, Bayer Healthcare, China
Amitabh Mishra, President & Chief Technology Officer, Emcure Pharma, India
Jennifer Harmon, Director of Clinical Affairs, SynAgile, Singapore
Zou Bin, Chief Scientific Officer, AUM Biosciences, Singapore

1040
Morning Networking and Refreshment Break


12th Annual Pharma Regulatory Affairs Asia commences


1115
Chairperson’s opening remarks

Du Xin, Senior Vice President and Head of Global Regulatory Affairs, Adlai Nortye, China


ENABLING NEW MARKETS WITH REGULATION


1130
Regulations and R&D – FDA Guidelines on Oncology Clinical Trials Makeover

  • Addressing changing regulatory landscape of oncology trial market in China
  • Regulations marching along with innovation, drivers of change, and clinical trial productivity
  • How is China’s clinical trials regulations changing?
  • FDA guideline updates

Du Xin, Senior Vice President and Head of Global Regulatory Affairs, Adlai Nortye, China

1215
Medicinal Cannabis Approval, Registration and Regulatory Updates

  • Background information and historical development of legalisation of medicinal cannabis in Thailand
  • Legislation and registration processes for approval of medicinal cannabis
  • Using clinical indications and evidence for regulatory affairs
  • Monitoring the impact of legalized medicinal cannabis in Thailand

Phusit Prakongsai, Acting Senior Advisor on Health Promotion, Office of Permanent Secretary, Ministry of Public Health, Thailand

1300
Networking Lunch


REGISTRATION, MANUFACTURING AND PRICING


1400
Better Testing, Better Treatment: The Dx and Rx relationship

Sarah Li, Director, Global Lab Team, Diaceutics, Singapore

1445
Streamlining Regulatory Strategies for Licensing, Submission, Approval and Market Access

Asmaa Asim, Regional Regulatory Affairs (SEA and South Korea), Boehringer Ingelheim, Singapore

1530
Afternoon Networking and Refreshment Break

1600
Country Specific Pricing and Market Access Strategies that Work

  • Working with regulatory bodies
  • Pricing opportunities and strategies
  • Common market access strategy downfalls, and remedies
  • Making local country partnerships work

 Moderator:
China – Du Xin, Senior Vice President and Head of Global Regulatory Affairs, Adlai Nortye, China

Panellists:
Poland – Justyna Kwiatkowska, Regulatory Affairs Specialist, Adamed Pharma, Poland
Singapore – Asmaa Asim, Regional Regulatory Affairs (SEA and South Korea), Boehringer Ingelheim, Singapore
Thailand
Phusit Prakongsai, Acting Senior Advisor on Health Promotion, Office of Permanent Secretary, Ministry of Public Health, Thailand

1630
Chairperson’s Closing Remarks & End of Conference Day One

Day 2 : Thu, 26 Sept 2019

0900
Chairperson’s Opening Remarks

Lan Mu, VP, Head of Global Regulatory Affairs, Bio-Thera Solutions


REGTECH AND DIGITALISATION


0910
EU NP eCTD and China eCTD Implementation and Development

Sophia Huang, Head of Regulatory Submission Management and Planning Beijing, Bayer Healthcare, China

0940
Regulatory Perspective on Blockchain Technology for Pharma’s Value Chain

  • Which part of pharma’s value chain is blockchain technology being used – now and future
  • What is the regulatory perspective of blockchain and how it impacts regulations in pharma

Meenu Batolar, Country Lead and Head – Regulatory Affairs, Corporate Affairs, CMO Lead and Drug Safety, UCB, India


CLINICAL OUTSOURCING AND COST MANAGEMENT


0950
RegTech Panel:
Advanced Technology, Regulatory Intelligence and Digitalisation

  • What are the technology trends in APAC?
  • Extensive use of software, AI and ML algorithms and modifications
  • How is regulatory framework changing with increasing use of technologies?
  • Cybersecurity
  • Where do we need to draw a line between tech and regulation?

Moderator:
Miguel Rivera, Business Transformation Director, Asia, Novartis, Singapore

Panelists:
Meenu Batolar, Country Lead and Head – Regulatory Affairs, Corporate Affairs, CMO Lead and Drug Safety, UCB, India
Sophia Huang, Head of Regulatory Submission Management and Planning Beijing, Bayer Healthcare, China
Noppadon Adjimatera, ASEAN & Japan/Korea Health Regulatory & Medical Affairs Director, Reckitt Benckiser, Thailand

1040
Morning Networking and Refreshment Break

1110
Regulatory Perspective on Blockchain Technology for Pharma’s Value Chain

  • Which part of pharma’s value chain is blockchain technology being used – now and future
  • What is the regulatory perspective of blockchain and how it impacts regulations in pharma

Meenu Batolar, Country Lead and Head – Regulatory Affairs, Corporate Affairs, CMO Lead and Drug Safety, UCB, India


COMBINATION PRODUCTS AND MEDICAL DEVICES


1140
Regulatory Development for Combination Products

  • How are combination products regulated?
  • New guidelines to support combination products development
  • Combination therapies of novel agents

Lan Mu, VP, Head of Global Regulatory Affairs, Bio-Thera Solutions

1155
Cyber Security Laws for Medical Devices

Miang Tanakasemsub, Regional Regulatory Affairs Head, Asia & Russia, Alcon, Singapore

1210
Networking Lunch


SPEED-TO-MARKET STRATEGY


1310
Comparison of ASEAN and EU (National and DCP Procedures) Requirements for Variations

  • Detailed comparison of requirements most commonly submitted variations (I.e. shelf-life extension, additional of new API source, name change of FP manufacturer) in ASEAN and EU
  • This will include both national and decentralised procedures regarding EU
  • Best practices

Justyna Kwiatkowska, Regulatory Affairs Specialist, Adamed Pharma, Poland


REGULATORY RISK MANAGEMENT


1345
Pharmacovigilance Guidelines and Controls

  • Overview on how PV regulatory requirements are evolving in APAC region
  • What are the main challenges in a constant changing environment?
  • Importance of PV inspection preparation and readiness

Gloria Bustos, Head of Pharmacovigilance EMEA and APAC, Baxter, Japan

1430
Afternoon Networking and Refreshment Break


OTC AND BIOSIMILARS


1500
Biosimilars Regulatory Strategies for CMC and Clinical Development

  • Regulatory strategies as living documents that have to be constantly re-evaluated and updated
  • Points to consider with respect to CMC and clinical development
  • Establishing and facilitating effective communication with Health Agencies

Allen Ho, Head of Regulatory Affairs, JHL Biotech, Taiwan

1530
Case Study: Succeeding in the OTC Market Through Effective Regulatory Pathways

Noppadon Adjimatera, ASEAN & Japan/Korea Health Regulatory & Medical Affairs Director, Reckitt Benckiser, Thailand

1600
Chairperson’s Summary & End of Main Conference