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Date

17-21 October

Platform

Virtual Zoom Meeting

Conference Schedule

Regulatory Agilities

Regulatory agilities and further accelerating patient access to safe and effective medicines and vaccines
  • Special Session: Regulatory agilities in the time of COVID-19 and beyond- perspectives from Singapore 
  • Opening & Welcome to the 11th ARC 
  • Regulatory Agilities & PQ KMS: What does it potentially mean for Asia? 
  • Fireside Chat: Why are innovative and agile regulatory systems important for patients, and how are patients engaging in regulatory activities? 
  • IFPMA Regulatory Agilities Project & Recommendations 
  • Perspectives on/Use of Regulatory Agilities in Asia 
  • Panel Session with Audience Q&A 

Post Approval Changes

Reliance, Convergence/Harmonization and Risk Based Approaches to PACs
  • Philippines FDA Perspective of convergence and Harmonisation in the context of PACs 
  • Realizing the objectives of the ICMRA PAC collaborative assessment pilot 
  • AstraZeneca’s Lessons learned in context of COVID-19 
  • Pfizer Experience with PACMP 
  • Good reliance practice and the link with PACs 
  • Illustration of a reliance pilot of a PAC 
  • What is PIC/S’s recommendations to demonstrate what an effective PQS is for PACs 
  • Industry experience of using risk-based approaches for PACs 
  • Panel Session 

Quality

Delivering products with the same quality standards to patients everywhere  
  • Today’s Supply chain Complexity 
  • Reliance with GMPs 
  • Perspectives on Product Sameness 
  • Panel Discussion 
  • Views on In-country Testing 
  • Role of WHO QC Labs Network 

ICH

ICH – The Foundations of Success  
  • Setting the scene: ICH and Where it is headed for the future (Keynote) 
  • Setting the scene: ICH & Training 
  • The Road to ICH Membership 
  • The role of industry in working with national regulatory authorities to implement ICH/Experience of experts 
  • Harvard MRCT Update 
  • How do clinical guidelines link together & what are the challenges (lens on E6/E8/E9/E17) 
  • E17 case studies – industry perspective 
  • Panel Discussion 

Biotherapeutics & Advanced Therapies

Changing regulatory landscape of Biotherapeutics and Cell & Gene Therapies
  • World Health Organization’s activities in developing guidelines for biotherapeutics and advanced therapy medicinal products (ATMPs) – (keynote) 
  • National Regulatory Authority and Industry overviews of biosimilar regulatory landscape, key topics (e.g. interchangeability, noncomparable biologics) 
  • Overview of ATMP regulatory landscape 
  • Panel Session 

Program Committee

Janis Bernat

Director, Scientific & Regulatory Affairs IFPMA

Sarah Adam

Associate Director, Regulatory Affairs IFPMA

Paula Barbosa

Associate Director, Vaccines Policy IFPMA

Mümün Gencoglu

Manager, Regulatory Affairs IFPMA

Sergio Cavalheiro Filho

Manager, Regulatory Affairs IFPMA

Alessandro Lazdins

Regulatory and Vaccine Policy Secondee IFPMA

Greg Perry

Assistant Director General IFPMA

Advisory Board

Director, Scientific & Regulatory Affairs IFPMA

Director and Head of Global Regulatory Affairs CEPI

Regional Regulatory Affairs APAC Merck Pte Ltd

Executive Director, Duke-NUS Senior Advisor, MOH

Head Asia Pacific Regulatory & Development Policy Novartis

Group Lead, Regulatory Convergence and Networks Team, WHO

Senior Director, APAC Regional Lead MSD

Associate Director of Global Regulatory Science and Policy,

AVP Regulatory Affairs Lead Asia Pacific MSD

Division Director, Division of Planning and Management Office of

Director, Quality External Affairs - JAPAC Amgen

President of MIASA Malaysia & Chairman of the

Executive Director SAPI

Director, Global Regulatory Policy Pfizer

Deputy Director, Integrated Development Global Health BMGF

Head Greater China and Intercontinental & Emerging Markets

Senior Administration Officer SAPI

Executive Assistant Office of the Chief Executive with

Speakers

Director and Head of Global Regulatory Affairs CEPI

Executive Director, Duke-NUS Senior Advisor, MOH

President of MIASA Malaysia & Chairman of the National Advocacy of Mental Health Association (NAMhA)

Director, Global Regulatory Policy Pfizer (more…)

Deputy Director, Integrated Development Global Health BMGF (more…)

Deputy Secretary-General PhIRDA (more…)

Senior Director, Global Regulatory Policy Development Pfizer

Associate Executive Director PMDA (more…)

Executive Assistant Office of the Chief Executive with resposibility for managing

Chief Executive Officer Health Sciences Authority Singapore

Global Quality Head of Innovation, Culture and Engagement Sanofi

Head - Global Regulatory Affairs Serum Institute of India Pvt. Ltd. (SIIPL)

Technical Officer Regulatory Convergence and Networks Team WHO

Quality Advocacy Leader Sanofi (more…)

GMP Inspector, Inspections Section Therapeutic Goods Administration

Director IV of the Center for Drug Regulation and Research Philippine Food

Executive Director Global CMC Regulatory Affairs AstraZeneca

Director Global Regulatory Affairs CMC Pfizer

Director, Global Regulatory Affairs, Greater China and Intercontinental Policy Lead GSK

Executive Director, Global Regulatory Policy MSD

Senior Regulatory Intelligence Manager - China Lead Novo Nordisk A/S