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10th Asia Regulatory Conference

8H30-10H30 CET/15H30–17H30 MYT: 3-6 November 2020

Date

3-6 November

Platform

Virtual Zoom Meeting

Conference Schedule

Conference Summary Report
8:30

Session 1 : Introducing Regulatory Reliance

  • WHO Activities: focus on reliance – Samvel Azatyan, WHO
  • Worksharing on Medicines Evaluation: the ACSS experience – John Skerritt, Adjunct Prof John Skerritt, Deputy Secretary for Health Products Regulation, Department of Health, Australia -
  • Industry Perspectives on Regulatory Reliance – Nevena Miletic (Roche) on behalf of IFPMA
  • Interactive Q&A Session
  

Session 2 : Moderated Panel Discussion

  • Patients Perspectives on Regulatory Reliance and Why Patient Engagement is Important - Ratna Devi, IAPO Board Member & Ranjit Kaur, Breast Cancer Welfare Association Malaysia
  
10:15

Session 3: Final Interactive Q&A for all Panellists

 
  
08:30

Session 1: Presentations & Panel Discussion

Keynote Speaker:
  • Role of ICMRA in Regulatory Strengthening and Convergence & Asia Training Center for Pharmaceutical and Medical Devices Regulatory Affairs - Dr. Yasuhiro Fujiwara (PMDA, ICMRA Vice-Chair)
Session 1:
  • Regulatory System Strengthening for Health Products in Asia – John Lim founding Executive Director of the Centre of Regulatory Excellence (CoRE) Duke-NUS
  • Progressing regulatory reliance in the Asia region by identifying efficient regulatory processes (OpERA Initiative) – Neil McAuslane, Director of the Center for Innovation in Regulatory Science (CIRS)
  • Best Practices – How Can the Pharmaceutical Industry Engage & Establish Dialogue with Various Coalitions and Collaborations – Dora Lau (Pfizer) on behalf of IFPMA
  
10:15

Session 2: Final Interactive Q&A for all Panellists

  
8:30

Session 1 : ICH in Asia

Keynote:
  • ICH at 30 – implementing reforms to build the future – Junko Sato, Office Director of Office of International Cooperation, MHLW/PMDA, MHLW/PMDA representative on ICH Management Committee
Moderated Panel Discussion:
  • Moderator: Angelika Joos – (MSD), IFPMA representative on ICH Management Committee, on behalf of IFPMA
  • Junko Sato - Office Director of Office of International Cooperation, MHLW/PMDA, MHLW/PMDA representative on ICH Management Committee
  • Hironobu Hiyoshi – Chair, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), JPMA Delegate to ICH Management Committee
  • Nihan Burul Bozkurt – Head of Clinical Trials Department, ICH Coordinator of TITCK, Turkey
  • David Jefferys - (Eisai), IFPMA Regulatory Science Committee Chair, on behalf of IFPMA
  • Pär Tellner - Director, Regulatory, Drug development and Manufacturing, EFPIA, EFPIA representative on ICH Management Committee
Audience Q&A
  
08:30

Session 1 : Agile Regulation for Supply Chain Management

Presentations
  • Supply chain management during COVID: Triggers for disruption & mechanisms in place to overcome them – Anthony McDonnell, Center for Global Development
  • The Importance of Agile In-country Quality Control Requirements – Barbara Allen (Eli Lilly) on behalf of IFPMA
  • Vaccine Registration Harmonization proposals & impact to other products in Asia – Samir Desai (President & Head, BU Biologics, Zydus Cadila) on behalf of DCVMN
  • COVID-19 Vaccines & Batch Release: Building on existing platforms to facilitate reliance during a pandemic – Ute Anna Rosskopf, WHO
  
9:30

Session 2: Moderated Panel Discussion and Q&As

Moderated Panel Discussion (25min)
  • Supply chain post-COVID – what “new normal” could look like
  • Implementation of digital solutions moving forward
 

Final Interactive Q&A for all Panelists (15min)

 

Wrap up & Final Remarks

  

Program Committee

Manabu Yanagisawa

Director Global Scientific and Regulatory Affairs Japan Pharmaceutical Manufacturers Association (JPMA)

Sannie Chong

Asia Pacific Technical Regulatory Policy Roche Singapore Technical Operations

Mic McGoldrick

Global CMC Policy Merck Sharp & Dohme Corp.

Janice Tan

Head of Regulatory Affairs Novartis Malaysia

Jayanthi Boobalan

Head of Regional Regulatory Hub, Global Regulatory Affairs International, Asia Pfizer Inc.

Alice (Seat Mee) CHEE

Executive Officer Pharmaceutical Association of Malaysia (PhAMA)

Janis Bernat

Director, Biotherapeutics & Scientific Affairs IFPMA

Sergio Cavalheiro Filho

Assistant Manager, Regulatory Affairs, IFPMA

Mümün Gencoglu

Manager, Regulatory Affairs IFPMA (more…)

Sarah Adam

Senior Manager for Regulatory and Scientific Affairs IFPMA

Greg Perry

Assistant Director General IFPMA   (more…)

Advisory Board

Janis Bernat

Director, Biotherapeutics & Scientific Affairs IFPMA

David Jefferys

Regulatory Science Committee Chair IFPMA (more…)

Neil McAuslane

Executive Director CIRS (more…)

John Lim

Executive Director, Duke-NUS Senior Advisor, MOH

Ratna Devi

Board Member IAPO (International Alliance of Patients Organizations)

John Skerritt

Adjunct Professor & ICMRA Vice Chair TGA / ICMRA

Datin Dr. Faridah Aryani Md. Yusof

Senior Director of Pharmaceutical Services, Ministry of Health, Malaysia NPRA (Malaysia)

Junko Sato

Office Director of Office of International Cooperation PMDA

Samvel Azatyan

Group Lead, Regulatory Convergence and Networks Team, WHO

 

Speakers

David Jefferys

Regulatory Science Committee Chair IFPMA (more…)

Neil McAuslane

Executive Director CIRS (more…)

John Lim

Executive Director, Duke-NUS Senior Advisor, MOH

Ratna Devi

Board Member IAPO (International Alliance of Patients Organizations)

John Skerritt

Adjunct Professor & ICMRA Vice Chair TGA / ICMRA

Datin Dr. Faridah Aryani Md. Yusof

Senior Director of Pharmaceutical Services, Ministry of Health, Malaysia NPRA (Malaysia)

Samvel Azatyan

Group Lead, Regulatory Convergence and Networks Team, WHO

Nevena Miletic

Global Regulatory Policy Group in F. Hoffmann-La Roche

Anthony McDonnell

Senior Policy Analyst CGD (more…)

Barbara M. Allen, PhD

Senior Director, Global Quality External Engagement Eli Lilly and Company

Hironobu Hiyoshi, PHD

Chair, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA) JPMA Delegate to

Dora Lau

Regional Regulatory & Clinical Trials Operations Manager at Global Regulatory Affairs

Yasuhiro Fujiwara, M.D., PHD

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)

Ranjit Kaur MSc.

President Breast Cancer Welfare Association Malaysia

Pär Tellner

Director Regulatory Affairs (European Federation of Pharmaceutical Industries and Associations)

Dr Hasenah Ali

Director of the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health

Nihan Burul Bozkurt

Head of Clinical Trials Department, ICH Coordinator of TITCK, Turkey

Samir Desai

President & Head, BU Biologics, Zydus Cadila

Ute Anna Rosskopf

WHO (more…)