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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

Download Schedule
8:30

Session 1 : Introducing Regulatory Reliance

  • WHO Activities: focus on reliance – Samvel Azatyan, WHO
  • Reliance Practices and Improving Public Health – Lembit Rägo, Secretary-General, CIOMS
  • 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

  • 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

Objective: Discuss future direction of ICH and highlight   implementation activities, experience and perspectives of newer ICH Members in Asia. Presentation: ICH at 30 – implementing reforms to build the future Panel Discussion
  
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 (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

Advisory Board

Janis Bernat

Director, Biotherapeutics & Scientific Affairs IFPMA

David Jefferys

Regulatory Science Committee Chair IFPMA (more…)

Neil McAuslane

Executive Director CIRS (more…)

Lembit Rägo

Secretary General CIOMS (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 NPRA (Malaysia)

Junko Sato

Office Director of Office of International Cooperation PMDA

Samvel Azatyan

Group Lead, Regulatory Convergence and Networks Team, WHO