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11th Asia Regulatory Conference

17-21 October 2022

Date

17-21 October, with a satellite session on 07 November

Platform

Virtual Zoom Meeting

Conference Schedule

Conference Program Conference Report
07:30 CET

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 
  
08:00 CET

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 
  
08:00 CET

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 
  
08:00 CET

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 
  
08:00 CET

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 
  
08:00 CET

Digitalization

Harnessing the power of digital tools for regulatory optimization Showcase different ongoing initiatives aimed at optimizing different parts of the regulatory environment through the use of digital tools such as:
  • Digital submissions: Accumulus’ cloud-based platform to support interactions between the industry and NRAs, improving speed, transparencies and efficiencies in the regulatory process.
  • E-labelling: e.g. How information-for-use videos and audio-read enabled functions are being used in Singapore through e-labeling
  • Artificial intelligence: e.g. Uppsala Monitoring Centre’s innovative methods used for signal detection and analysis with VigiBase.
  • Share real case studies (e.g. ongoing pilots) and lessons learned from NRAs in the region.
Register here: https://us06web.zoom.us/webinar/register/WN_wMlk3WKaRuy-KWM_b8UQhw#/registration
  

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

Janis Bernat

Director, Scientific & Regulatory Affairs IFPMA

Adam Hacker

Director and Head of Global Regulatory Affairs CEPI

Siew-hong Lek

Regional Regulatory Affairs APAC Merck Pte Ltd

John Lim

Executive Director, Duke-NUS Senior Advisor, MOH

Kum Cheun Wong

Head Asia Pacific Regulatory & Development Policy Novartis

Samvel Azatyan

Group Lead, Regulatory Convergence and Networks Team, WHO

Sannie Chong

Senior Director, APAC Regional Lead MSD

Runyi Mo

Associate Director of Global Regulatory Science and Policy,

Warren Beck

AVP Regulatory Affairs Lead Asia Pacific MSD

Daisuke Koga

Division Director, Division of Planning and Management Office of

Dinesh Khokal

Director, Quality External Affairs - JAPAC Amgen

Anita Abu Bakar

President of MIASA Malaysia & Chairman of the

Christina Teo

Executive Director SAPI

Julie O’Brien

Director, Global Regulatory Policy Pfizer

Raj Long

Deputy Director, Integrated Development Global Health BMGF

Céline Bourguinon

Head Greater China and Intercontinental & Emerging Markets

Lily Lim

Senior Administration Officer SAPI

Karl Cogan

Executive Assistant Office of the Chief Executive with

Speakers

Adam Hacker

Director and Head of Global Regulatory Affairs CEPI

John Lim

Executive Director, Duke-NUS Senior Advisor, MOH

Anita Abu Bakar

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

Julie O’Brien

Director, Global Regulatory Policy Pfizer (more…)

Raj Long

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

Xiaoti Lu

Deputy Secretary-General PhIRDA (more…)

Judith Macdonald

Senior Director, Global Regulatory Policy Development Pfizer

Nobumasa Nakashima

Associate Executive Director PMDA (more…)

Karl Cogan

Executive Assistant Office of the Chief Executive with resposibility for managing

Choong May Ling

Chief Executive Officer Health Sciences Authority Singapore

Thierry Gastineau

Global Quality Head of Innovation, Culture and Engagement Sanofi

Parag Nagarkar

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

Marie Valentin

Technical Officer Regulatory Convergence and Networks Team WHO

Lyne Le Palaire

Quality Advocacy Leader Sanofi (more…)

Lyndall Brennan

GMP Inspector, Inspections Section Therapeutic Goods Administration

Jesusa Joyce N. Cirunay

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

Diane Wilkinson

Executive Director Global CMC Regulatory Affairs AstraZeneca

Connie Langer

Director Global Regulatory Affairs CMC Pfizer

Andrew Deavin

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

Angelika Joos

Executive Director, Global Regulatory Policy MSD

Anette Hjelmsmark

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

Sara Wang

Executive Director, Science and Regulatory RDPAC

Rosilawati Ahmad

Deputy Director NPRA (more…)

Yuki Ando

Senior Scientist for Biostatistics PMDA (more…)

Isabelle Colmagne-Poluard

GRASP Merck (more…)

Paul Mendoza

President Psoriasis Philippines (more…)

Chaitanya Koduri

Director, International Government and Regulatory Engagement USP

Joerg Garbe

Global Quality Manager & Policy Lead Roche

Lisa Kerr

Head of the Therapeutic Goods Administrations Laboratories Branch TGA

Mike Saleh

Director Regional Regulatory Advisor for Russia/Turkey/East Europe/ EEU/ AFME CMC