Pharmaceutical Regulatory Affairs – Agenda

All timings are in SGT (UTC +8). Click here to convert to your timezone »

Day 1


Opening Plenary


13:00
KEYNOTE ADDRESS:
COVID-19 Treatments and Vaccines – Ushering in a New Era for Regulation, Collaboration, and Drug Accessibility

Dr. Andreas Schmidt, Chief Executive Officer, Proteona, Singapore/Germany

13:30
PHARMA LEADERS’ THINK TANK:
Redefining Pharma’s Role in the Global Healthcare Reform Agenda

  • COVID-19 vaccines candidate development
  • Regulations on pandemic drugs approval and accelerated clinical trials under diverse regimes
  • Future of pricing and affordability for Novel Drugs
  • Why technology should be the key component to surviving COVID-19?
  • AI and its immense potential in use of pandemic treatments and early detection

Panellists:
Dr Sucharita Das, Senior Consultant Regulatory Affairs and Quality Assurance Global/APAC
Edsel Pereira
, Group Vice President – Information Technology, Glenmark Pharmaceuticals, India
Alexander Zach
, Senior Vice President, Global Head of Market Access and Policy, Biocon, India
Dr. Keith Carpenter
, A*STAR Senior Fellow, Pharma Innovation Programme Singapore (PIPs), Singapore

14:10
Online Networking and Stretch Break


Regulatory Priorities Post COVID-19


15:00
Assessing Regulatory Requirements and Expectations In Japan During COVID-19

  • Key regulatory aspects for new drugs development in japan
  • Approval timelines and accelerated review system
  • New regulation on shorten the clinical trials notification (CTN) of Covid-19 candidate product
  • New developments and outlook for Cell & Gene Therapy products

Yuko Kikuchi, Senor Director Asia Regulatory Affairs, Eisai, Japan

15:30
Regulatory Transformation and the Drug Approval Process in Vietnam

  • Major issues facing regulatory transformation in Vietnam
  • Ongoing regulatory reform
  • GAMP and compliance update

Ewelina Markuszewska, Quality Control Expert, DaviPharm (Adamed Group), Vietnam

16:00
Regulatory Leaders’ Dialogue:
Managing Expectations from Regional FDAs During and After COVID-19

  • Renewals and ‘sunset clause’
  • Potential COVID products and choosing the right paths with FDAs
  • COVID -19 impacts on trials conducts
  • Understanding and working well with FDAs’ prioritisation rationale
  • Revisiting regulatory strategies during and thereafter pandemic
  • Challenges to opportunities – Timelines management for documentation, submission and approvals
  • Regulatory Affairs expert views on successful pathways during pandemic whilst meeting regulatory goals

Panellists
Yuko Kikuchi, Senor Director Asia Regulatory Affairs, Eisai, Japan
Santosh Kumar Jha
, Head, Head, Asia Pacific Region Medical & Regulatory Affairs, Takeda, Singapore
Ewelina Markuszewska
, Quality Control Expert, DaviPharm (Adamed Group), Vietnam
Sophia Huang
, Regional Group Head, Regulatory Submission Management, Bayer, China


COVID-19: REGULATORY FEXIBILTY AND DEVELOPMENTS


16:40
Key Steps to Take When Inspections Go Wrong

Dr Sucharita Das, Senior Consultant Regulatory Affairs and Quality Assurance Global/APAC

17:10
Regulatory Affairs Priority Setting:
Speed and Flexibility for Drug Development During and After COVID-19

  • Regulatory priorities for department and wider company
  • Better and efficient engagement with Authorities for speed to market authorisation plans – Benchmarking globally
  • Working well with anticipated regulatory changes post COVID-19
  • Regulatory update of drug development on Covid-19

Moderator :
Shun Jin, Head Regulatory Affairs EMA, Sandoz Asia Pacific, Singapore

Invited Panellists:
Aziza Ahmed, Director, APAC CMC Regulatory Affairs, MSD International GMBH, Singapore
Diani Savitri, Regulatory & Pharmacovigilance Director, Soho Global Health, Indonesia

18:00
End of Virtual Conference Day 1

Day 2


COVID-19: Regulatory Flexibility And Developments


13:00
Regulatory Perspective:
Expediting Drug Approval During COVID-19 Outbreak

  • Takeda pharma initiatives on developing Plasma-derived therapy to treat COVID-19 patients
  • Therapeutic development procedures
  • Regulatory view on expediting drug approval during Covid-19 outbreak
  • Latest progress on the drug development

Santosh Kumar Jha, Head, Asia Pacific Region Medical & Regulatory Affairs, Takeda, Singapore

13:30
Life-Cycle Approach to Quality and Safety of Pharmaceutical Products – Case Study During COVID-19 Crisis

  • Current trends in global lifecycle management and situation in the region
  • Challenges in the development and manufacture of complex drug delivery devices
  • Strategy to navigate the complexities of CMC process

Dr. Nirmal Kumar, Head-QA, Novugen Pharma (Malaysia) Sdn Bhd, Malaysia

14:00
Regional Progress and Update on Multi Regional Clinical Trials (MRCTs)

  • MRCTs and COVID trials updates
  • Roadmap to promote MRCTs in Asia
  • Key consideration for effective regulatory decision-making using MRCTs

Speaking opportunity please contact dewi.febianti@informa.com


Pricing, Products and Regulations           


14:30
The Update on the New Price Control Implementation in the Philippines

  • Are price controls the solution to expensive drugs?
  • The update on the new retail price regulation
  • Long-term investment impact in the Philippines’s pharma industry
  • Strategy to manage the cost containment

Catherine Clemente, Associate Lead, Drug Regulatory Affairs & Pharmacovigilance, Sandoz, Philippines

15:00
Online Networking and Stretch Break

15:30
Generics, Biosimilars, Combination Therapies and Biologics

  • Global development update for biologic products
  • Overview of the registration procedure and approval process for both generics and biosimilars in Asia
  • Pricing mechanisms
  • Commercialisation risk during COVID-19 pandemic

Pakhi Rusia, Director, Global Regulatory Affairs, GlaxoSmithKline Consumer Healthcare, Singapore

16:00
Asia OTC Regulatory Strategy
Development

  • OTC regulatory framework in Asia Pacific
  • ASEAN pharmaceutical harmonization implementation and its implication to OTC development
  • Case study

Srilatha Sreepathy, Associate Director, Regulatory & Pipeline Strategy Asia, Procter & Gamble, Singapore

16:30
Knowledge Session:
Regulatory Submissions Guidance:

  • Working with Various FDAs During COVID-19
  • The Case Study of: United States, EU, China, Australia, New Zealand and ASEAN countries

Speaking opportunity please contact dewi.febianti@informa.com

17:00
End of Day 2 Virtual Conference
                         

Day 3


Digitally Transformed Reg Affairs


13:00
Digital Transformation and Regulatory Needs

  • Regulatory developments to support the digitalization of pharma
  • Challenges, opportunity, and benefit
  • Pharma digitalization implementation in Thailand

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

13:30
International eCTD Implementation and Examining the Common Pitfalls

  • Timelines, scope and pros and cons in Asia
  • Assessing the status of eCTD v4.0
  • Successful case study of eCTD implementation
  • An update on eSubmission in China

Sophia Huang, Regional Group Head, Regulatory Submission Management, Bayer, China

14:00
E-Retail Regulatory Updates:
E-Commerce and Consumer Healthcare

  • Relationship between Self-care and e-Commerce
  • E-Commerce model used in consumer self-care environment
  • Learnings from ASEAN countries

Woei Lee Chen, Head of Regulatory Affairs, Reckitt Benckiser, Singapore

14:30
Knowledge Session:
eCTD in APAC and Technology Transformation

  • Addressing digitally transformed regulatory affairs

Speaking opportunity please contact Yvonne.Leong@informa.com

15:00
Online Networking and Stretch Break


Pharmacovigilance


15:30
Pharmacovigilance System and Its Implementation in Indonesia

  • Examining Indonesia’s regulatory landscape
  • What are the regulatory pathways and strategic considerations for successful clinical trial and marketing applications?
  • Regulatory risk management on pharmacovigilance – pre and post marketing

Diani Savitri, Regulatory & Pharmacovigilance Director, Soho Global Health, Indonesia

16:00
Comparisons of CMC Variations in the Region & Managing Complications

  • Requirements and challenges in design and change in manufacturing process and product specifications
  • Stability studies
  • Similarities and differences with post approval changes in ASEAN/US/EU
  • How these CMC processes and issues relate to the product’s regulatory strategy

Aziza Ahmed, Director, APAC CMC Regulatory Affairs, MSD International GMBH, Singapore


JOINT CLOSING PLENARY SESSION


16:40
DIVERSITY & INCLUSION IN PHARMA:
Cultivating the Next-Gen of Women Leaders in Pharma

  • Why does gender equality matter on the board?
  • Key challenges facing women leaders in Pharma
  • Management efforts to address some of these challenges, and remaining gaps
  • Reflections on the journey to the top
  • Breaking the glass ceiling: Lessons learnt along the way, and advice to my younger self
  • Management efforts to address some of these challenges, and remaining gaps

Panelists:
Anupama Rao Singh, Business Head – LATAM | Head – Oncology and Institutional Business COE, Dr.Reddy’s Emerging Markets, Dr Reddys, India
Angela Brady
, Director of Innovation Research, APAC R&D, GSK, Singapore
Chandana Yeluri, Head- Digital and Continuous Improvement, Sandoz Development Center, Novartis, India
More panelists to be confirmed

17:40
End of Day 3 Virtual Conference