Asia Regulatory Conference 2013

Day 1 Monday, January 28, 2013

• 9:00AM - 9:30AM

  Opening Ceremony

  Speaker(s):

  • Welcome from the Drug Information Association (DIA)
    Ling Su, PhD
    Strategic Advisor, Life Sciences
    Sidley Austin LLP, China
  • Welcome from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and Japan Pharmaceutical Manufacturers Association (JPMA)
    Toshiaki Miyoshi
    Managing Director
    Japan Pharmaceutical Manufacturers Association, Japan
  • Program Chairpersons Opening Remarks
    Arun Mishra
    Senior Director, Global Regulatory Affairs - EMAP Region
    GlaxoSmithKline, United Kingdom
  • Welcome Remarks by Guest of Honour
    Amy Khor, PhD
    Minister of State
    Ministry of Health and the Ministry of Manpower, Singapore
• 9:30AM - 10:30AM

  Regulators and Industry Working Together to Have Safer and Better Access to Medicine

  Speaker(s):

  • Regulators and Industry Working Together to Have Safer and Better Access to Medicine
    John C W Lim, MD,MS,MSc
    Chief Executive Officer
    Health Sciences Authority, Singapore
  • Cooperation Between Drug Regulators & Industry
    Barbara J Sabourin, FACP
    Director General
    Health Canada (HPFB), Canada
• 11:00AM - 12:00PM

  Path to the Future: Status and Future of Research and Development

  
  Session Chair(s):

  • Yves Juillet, MD
    Senior Vice-President
    Industrie Sante, France

  Science is constantly moving forward. Implementing these new concepts or even creating them in drug Research and Development is key. It implies for Regulatory Authorities and Industry researchers a permanent adaptation to these new paradigms thanks to the development of Regulatory Science.

  Speaker(s):

  • Advancing the Science of Medicines Regulation: The Role of the 21st Century Medicines Regulator
    Murray M. Lumpkin, MD,MSc
    Commissioner's Senior Advisor and Representative for Global Issues, OC
    FDA , United States
  • Speaker
    James Garner, MA,MBA
    Vice President & General Manager
    Takeda Global Research & Development Center (Asia), Singapore
• 1:30PM - 3:00PM

  Asia’s Role in Drug Development: A Global and Regional Perspective

  
  Session Chair(s):

  • Romi Singh, PhD
    Executive Director, Global Regulatory Affairs and Safety
    Amgen Inc., United States
  • Tomas Salmonson, PhD
    CHMP Chairman
    MPA, Sweden

  Historically, drug registrations in Asia followed, and to a large extent depended on, the Western drug development. However, over the recent years, there has been an increasing trend of Asia becoming a hub of global drug innovation and development. This session will discuss how Asia contributes to the global drug development and provide examples of how data generated primarily in Asia is used for registration in the West (US, EU).

  Speaker(s):

  • Contribution of Asia in Execution of Global Clinical Trials
    Yoshimasa Shimoto, PhD
    Vice President, Asia Development (Region Head)
    Daiichi Sankyo Co., Ltd., Japan
  • Asia's Role in Drug Development - an European Perspective
    Tomas Salmonson, PhD
    CHMP Chairman
    MPA, Sweden
  • Concept of Adaptive Licensing and Its Feasibility for a New Pathway of Drug Development from the Regional and Global Regulators' Perspective
    Raymond S.B. Chua, MD,MBA,MPH,FRCP
    Group Director, Health Products Regulation Group
    Health Sciences Authority, Singapore
• 3:45PM - 5:15PM

  Asia's Role in Drug Development: A Global and Regional Perspective - continued

  Speaker(s):

  • Asia’s Role in Drug Development: A Global and Regional Perspective - continued
    Joseph C. Scheeren, PharmD
    Senior Vice President, Head Global Regulatory Affairs
    Bayer Healthcare Pharmaceuticals, United States
  • Innovative R&D Approaches: Opportunities in Asia
    Jogarao V. Gobburu, PhD,MBA
    Professor, School of Pharmacy and School of Medicine
    University of Maryland, United States
  • Asian Collaboration of Safety Biomarker Qualification Activity in Near Future
    Etsuko Usui
    Manager
    Novartis Pharma K.K., Japan

Day 2 Tuesday, January 29, 2013

• 9:00AM - 10:45AM

  Global Review Practices: Industry & Regulatory Working Together

  
  Session Chair(s):

  • Cordula Landgraf, RPh
    Head of Networking
    Swissmedic, Switzerland
  • Steven K Galson, MD,MPH
    VP Global Regulatory Affairs
    Amgen Inc., United States

  “Coming Together is a Beginning, Keeping Together is Progress, Working Together is Success” (Henry Ford) In this sense, the session will look at how Industry and Regulatory already work together and what could be done by both sides in terms of effective and efficient review processes to further strengthen and improve this co-operation. Is the model of work sharing between Regulatory Agencies the way to enable effective resource utilization to finally streamline approval? And how could the review process evolve to balance early access to new drugs with the need for comprehensive data?

  Speaker(s):

  • Elements of an Effective and Efficient Review Process from an Agency Point of View
    Dato' Eisah A. Rahman
    Senior Director of Pharmaceutical Services
    Ministry of Health Malaysia, Malaysia
  • How Does Industry See the Review Process Evolving to Address the Needs of Tomorrow?
    Paul D. Huckle, PhD,MPharm,RPh
    Senior Vice President, Global Regulatory Affairs
    GlaxoSmithKline, United States
  • Is there an Internationally Acceptable Framework for Benefit-Risk Assessment of Medicines that will enable a Regulatory and Industry collaboration for improved decision making?
    Stuart Walker, PhD
    Founder
    Centre For Innovation In Regulatory Science (CIRS), United Kingdom
  • Results of APEC Good Review Practices (GRP) Project
    Chao-Yi Wang, MSc
    Deputy Director, Division of Drugs and New Biotechnology Products
    TFDA, Taiwan
• 11:15AM - 12:30PM

  Global CMC Reviews: Challenges and Opportunities

  
  Session Chair(s):

  • Lucky Surjadi Slamet, MSc
    Deputy,Therapeutic Prod, Narcotics, Psychotropic and Addictive Substance Control
    NADFC, The Republic of Indonesia, Indonesia
  • Chi-Wan Chen, PhD
    Executive Director, Global CMC, Global Research & Development
    Pfizer Inc, United States

  This session will discuss CMC challenges that are faced by the industry in obtaining a right first time approaches to securing successful filing and regulatory approval of pharmaceuticals, biological and vaccines in Asia. The session will cover not only the challenges encountered by industry but also the available opportunities for ensuring a smooth filing and approval from a regulator perspective.

  Speaker(s):

  • CMC Review: Challenges and Opportunities - Singapore HSA Perspective
    Dinesh Khokal, PhD,MSc
    Regulatory Consultant, Generics & Biosimilars Branch
    Health Sciences Authority, Singapore
  • Changes in CMC Submission and Review
    Zhen Chen, PhD
    Deputy Office Director, Office of New Drug Pharmaceutical Science
    Center for Drug Evaluation of CFDA , China
  • Challenges to Multi-National Companies in a Global Regulatory Environment – with Case Studies
    Chi-Wan Chen, PhD
    Executive Director, Global CMC, Global Research & Development
    Pfizer Inc, United States
• 11:15AM - 12:30PM

  Clinical Reviews

  
  Session Chair(s):

  • Mark J. Goldberger
    Vice President, Regulatory Intelligence and Policy
    Abbott Laboratories Inc., United States

  Participants will hear from regulators and from industry about the critical elements of a product review. How do regulators "get the most bang for their buck and what are they most likely to be looking for. There will also be a discussion of the steps that a sponsor can take to facilitate the review process.

  Speaker(s):

  • Role of Clinical Review in SFDA/CDE: Yesterday, Today and Tomorrow
    Yi Feng
    Office of Evaluation Management and Communication
    Center for Drug Evaluation of CFDA , China
  • How to Win the Lottery on the Review Process
    Krishna Prasad, MD,FRCP
    Clinical Assessor/Consultant Cardiologist
    Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
  • Sound Clinical Reviews: Mind over Matter - Any Role for the Heart?
    Aamir Shaikh, MD
    Founder
    Assansa, India
  • Panelist
    Ning Li, MD,PhD
    Vice President, GRA Head, Medical Policy, Asia
    Sanofi, China
• 2:00PM - 3:30PM

  Biosimilars

  
  Session Chair(s):

  • Cecil J. Nick, MS
    FTOPRA, Vice President (Technical)
    PAREXEL Consulting, United Kingdom

  Biosimilarity is a concept first introduced into European legislation almost a decade ago to allow regulatory approval of similar biological medicines following submission of limited yet targeted data showing similarity to the reference biological product based on the totality of physico-chemical, biological, non—clinical and clinical testing. This concept has now spread across the globe with guidelines and regulations issued by all major regulatory agencies including WHO and those in US, Japan, Canada and Korea. This session will explore various view points on the critical considerations applicable to making affordable yet safe and effective similar biological medicines available globally.

  Speaker(s):

  • Biosimilarity and the Challenges in Desigining a Global Regulatory Program
    Cecil J. Nick, MS
    FTOPRA, Vice President (Technical)
    PAREXEL Consulting, United Kingdom
  • The Regulatory Pathway of Biosimilars - From Regulatory Guidance to the Assessment of Data
    Pekka T Kurki, MD,PhD
    Research Professor
    Finnish Medicines Agency, Finland
  • A Global Regulatory Biosimilar Program - Rising to the Challenge
    Heui Yun Joo
    Manager, Purification Process Team
    Celltrion Inc., Korea, Republic of
• 2:00PM - 3:30PM

  Supply Chain Integrity: From Clinical Trials to Market

  
  Session Chair(s):

  • Brian Johnson
    Senior Director, Supply Chain Security
    Pfizer Inc, United States

  Supply chain security threats to our industry are on the rise globally. Collaboration is essential between all stakeholders in the supply chain to fight these crimes. This session will explore the threats our industry faces and any trends we are seeing. We will explore the benefits of a holistic approach to the problem from different stakeholder perspectives and explore the following questions. How can manufacturers organize around these threats? How can trade organizations help facilitate industry wide collaboration? How can regulatory convergence help? What specific initiatives are mobilizing in the Asia / Pacific region? We hope to shed some light on the problem and discuss mechanisms to prevent, detect, and respond to supply chain security threats.

  Speaker(s):

  • Supply Chain Security from a Pharmaceutical Company Perspective
    Brian Johnson
    Senior Director, Supply Chain Security
    Pfizer Inc, United States
  • APEC RHSC Regulatory Harmonization Steering Committee
    C. Michelle Limoli, PharmD
    Director, Harmonization and Multilateral Relations Office, OC
    FDA, United States
  • APEC Supply Chain Security Strategy
    Mark Paxton, JD,PhD
    Regulatory Counsel, OC, CDER
    FDA, United States
  • Supply Chain Security - the Role of an Industry Consortium
    Tim Valko
    Executive Director, Risk Management
    Amgen, United States
• 4:00PM - 5:30PM

  ASEAN Regulator Working Group Panel Discussion

  
  Session Chair(s):

  • Vincent I. Ahonkhai, MD
    Senior Regulatory Officer, Global Health Delivery
    Bill & Melinda Gates Foundation, United States
  • Dato' Eisah A. Rahman
    Senior Director of Pharmaceutical Services
    Ministry of Health Malaysia, Malaysia

  DIfferences in the regulatory requirements of individual ASEAN Member States has a huge impact on economic growth, social progress, and cultural development. This panel will discuss how the ASEAN Regulator Working Group is working to eliminate technical battiers to trade posed by regulations without compromising product quality, efficacy and safety. Panel members will highlight achievements made toward regulatory convergence through shared practices, work-sharing and transparency.

  Speaker(s):

  • Panelist
    Siti Aida Abdullah
    Deputy Director
    Ministry of Health Malaysia, Malaysia
  • Panelist
    Wilai Bundittanugula
    Former Director
    Ministry of Public Health, Thailand
  • Panelist
    Marie Tham, RPh
    Advisor (International Collaboration), Health Products Regulation Group
    Health Sciences Authority, Singapore, Singapore
  • Panelist
    Rosni Jair
    Senior Scientific Officer, Drug Quality Section
    Ministry of Health, Brunei Darussalam
  • Panelist
    Soulyvanh Keokinnaly
    Technical Officer, Food and Drug Department
    Ministry of Health Lao PDR, Lao People's Democratic Republic
  • Panelist
    Kenneth Y Hartigan-Go, MD
    Professor, Dept. of Pharmacology, College of Medicine
    University of Philippines, Philippines

Day 3 Wednesday, January 30, 2013

• 9:00AM - 10:30AM

  Emerging Trends

  
  Session Chair(s):

  • Alistair Davidson
    Senior Director, Global Regulatory Development, Asia Pacific
    PPD, United Kingdom
  • Toshiyoshi Tominaga, PhD
    Professor and Director, Center for Drug and Food Clinical Evaluation
    Osaka City University Hospital (OCUH), Japan

  This session will oversee some upcoming topics which are likely to need serious regulatory consideration in Asia in the near future. These may be already developed to some form in other parts of the world, but are still evolving and this gives an opportunity for the regulatory authorities in Asia as well as Industry partners to start to consider how these issues can be incorporated within the ongoing regulatory timetable. Heath Technology Assessments is a key area for the near-medium term as governments and regulatory authorities strive to deliver access of the best possible healthcare products, while keeping the costs under control. Other presentations will look at emerging technical challenges which will pose questions for regulators and Industry in the region over the next few years.

  Speaker(s):

  • Evolving the Fourth Pillar: Health Technology Assessments (HTAs) in Asia
    David Grainger
    Global Public Policy Director
    Eli Lilly & Company, Australia
  • Globalization and Individualization
    Toshiyoshi Tominaga, PhD
    Professor and Director, Center for Drug and Food Clinical Evaluation
    Osaka City University Hospital (OCUH), Japan
  • Bringing Transparency, Quality and Predictability in Indian Regulatory Environment – An Example of e-Governance in Gujarat State of India
    Hemant Koshia
    Commissioner
    Food and Drugs Control Administration, Gujarat, India
• 11:00AM - 12:30PM

  Asia Regional Update on Convergence

  
  Session Chair(s):

  • Jerry Stewart, JD,MS,RPh
    Regulatory Policy Head, Emerging Markets
    Pfizer, United States
  • Chao-Yi Wang, MSc
    Deputy Director, Division of Drugs and New Biotechnology Products
    TFDA, Taiwan

  This session will present both industry’s and the regulatory authorities’ views on the status of regulatory convergence in Asia. Examples of Regulatory convergence and divergence will be discussed, including recommendations on how to progress more convergence in areas such as clinical development, submission standards, risk-benefit assessments and approval time lines. Highlights from APEC RHSC, PhRMA and other organizations will help to paint a picture of the current regulatory environment and emerging topics on harmonization for attendees to consider.

  Speaker(s):

  • Overview of Regulatory Convergence in Asia
    Gloria Hung
    Senior Manager - RA
    Pfizer CORPORATION HONG KONG LIMITD, Hong Kong
  • Recent Convergence Efforts
    Justina A. Molzon, JD,MPharm
    Associate Center Director for International Programs, CDER
    FDA, United States
  • Industry's Role in APEC RHSC
    Wen Chang, PhD
    Vice President, North Asia Strategy and China Regulatory Sciences
    Bristol-Myers Squibb Company, China
  • TFDA's View on Regulatory Harmonization and Its Efforts to Implement It
    Chao-Yi Wang, MSc
    Deputy Director, Division of Drugs and New Biotechnology Products
    TFDA, Taiwan
• 12:30PM - 12:45PM

  The World Bank: Overview Regulatory Harmonization Activities in the ASEAN Region
• 2:00PM - 3:30PM

  Counterfeit

  
  Session Chair(s):

  • Ruth Lee
    Director, Enforcement Branch
    Health Sciences Authority, Singapore
  • Raymond H. Velez
    Regional Manager, South Asia Pacific, Global Product Protection
    Eli Lilly (Singapore) Pte., Ltd., Singapore

  Counterfeit medical products pose a significant danger to public health in both developing and developed countries. The global nature of manufacturing and trade in medical products makes it crucial that all countries work together in a concerted effort to reduce the growing market for counterfeit medical products. In this session, three key speakers representing WHO, INTERPOL and Pharmaceutical Security Institute (PSI) will highlight their respective roles and responsibilities, as well as their efforts in combating this global problem of counterfeit medical products. Sensitivities surrounding this topic and the challenge of achieving effective collaborations among all stakeholders to achieve the common goal of protecting public health and safety will also be discussed.

  Speaker(s):

  • INTERPOL's Successful Model in Combating Cyber Pharmaceutical Crime
    Cecilia Fant
    Superintendent
    INTERPOL, France
  • PSI - A Unique Ally and Key to Effective Partnerships
    Thomas T. Kubic
    President & CEO
    Pharmaceutical Security Institute, United States
  • Counterfeit and Supply Chain
    Mohd Hatta Bin Ahmad
    Director of Pharmacy Enforcement Division
    Ministry of Health Malaysia, Malaysia
• 2:00PM - 3:30PM

  Pharmacovigilance and Risk Management

  
  Session Chair(s):

  • Kenneth Y Hartigan-Go, MD
    Professor, Dept. of Pharmacology, College of Medicine
    University of Philippines, Philippines
  • Florence Houn, MD,MPH,FACP
    FDA Alumni Association; Celgene, United States

  It is well recognized that despite rigorous pre-market regulation process, post-market surveillance is essential to ensure that the benefit/risk balance of health products remains favourable throughout the product’s lifecycle. In the recent years, known or potential safety issues that require monitoring are identified prior to product registration and ways of communicating these issues to healthcare professionals and patients, as well as enhanced surveillance methods are developed. These risk mitigating strategies are presented in the form of a risk management plan, specific for each product. In this session, representatives from both regulatory agencies and the industry will share on elements of pharmacovigilance and the implementation of risk management plans.

  Speaker(s):

  • Pharmacovigilance in Singapore
    Cheng Leng Chan
    Deputy Group Director, Health Products Regulation Group
    Health Sciences Authority, Singapore
  • Pharmacovigilance Updates in Japan and Risk Management Plans
    Kosuke Haneda, PhD
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • New EU Legislation: Impact on Risk Management and Post Market Surveillance in Asia
    Siew Huey Liew
    Associate Manager, Drug Safety and Epidemiology
    Novartis (Singapore) Pte., Ltd., Singapore
  • Current Challenges to Cope with Risk Management of Medicines
    Hubert G. M. Leufkens, PharmD
    Chairman
    Dutch Medicines Evaluation Board, Netherlands
• 3:30PM - 4:30PM

  Path to the Future: Regulatory Panel Discussion

  
  Session Chair(s):

  • Yves Juillet, MD
    Senior Vice-President
    Industrie Sante, France

  The purpose of this Regulatory Panel discussion at the close of the Conference is to gain and share insights on the practical meaning and implications of regulatory convergence and cooperation among regulators for the acceleration of patient access to medicines and the protection and promotion of the quality of medical products. After 3 days of sessions and discussions around the main theme of the Conference, this final session will aim to envision a path to a future of greater benefit for regional global patients – recognizing both the opportunities and the remaining challenges, and possible ways to address them. Based on the discussions during the first 3 days of the Conference, the Co-Chairs will identify 2-3 themes relevant to the Path to the Future and will solicit comments, from each panelist.

  Speaker(s):

  • Panelists
    Cordula Landgraf, RPh
    Head of Networking
    Swissmedic, Switzerland
  • Panelists
    Murray M. Lumpkin, MD,MSc
    Commissioner's Senior Advisor and Representative for Global Issues, OC
    FDA , United States
  • Panelists
    Toshiyoshi Tominaga, PhD
    Professor and Director, Center for Drug and Food Clinical Evaluation
    Osaka City University Hospital (OCUH), Japan
  • Panelists
    John C W Lim, MD,MS,MSc
    Chief Executive Officer
    Health Sciences Authority, Singapore
  • Panelists
    Dato' Eisah A. Rahman
    Senior Director of Pharmaceutical Services
    Ministry of Health Malaysia, Malaysia
• 4:30PM - 5:00PM

  Closing Remarks

  Speaker(s):

  • Arun Mishra
    Senior Director, Global Regulatory Affairs - EMAP Region
    GlaxoSmithKline, United Kingdom
  • John C W Lim, MD,MS,MSc
    Chief Executive Officer
    Health Sciences Authority, Singapore