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Date

February 12-13 2020

Location

ALOFT KUALA LUMPUR SENTRAL HOTEL, KUALA LUMPUR, MALAYSIA

Conference Schedule / draft

Attendee Registration

Welcome Remarks by Advisory Board Co-Chairs

Robust Regulatory Frameworks as a Pillar of Universal Health Coverage (UHC)

Regulatory System Strengthening in Malaysia

Coffee / Tea Break

Patients’ Perspectives on Regulatory Reliance – A Moderated Panel Session

Why are patient engagement and advocacy efforts  important and how can regulatory efficiency be linked to improved health outcomes/UHC - A armchair discussion with Ratna Devi (IAPO Board member).

WHO Regulatory Systems Strengthening Activities: Focus on Reliance

Good regulatory and reliance practices; Global benchmarking process; Support to Regional Regulatory Initiatives (ASEAN)

Tools to Facilitate Regulatory Reliance & Review – Assessment reports, WHO CPP Scheme, GMP Inspections

Presentations on Reliance practices and improving public health / work-sharing / tools for implementation of reliance pathways / industry case study / interactive Panel discussion

Lunch & Learn Session (Optional)

Regulation of Cell & Gene Therapies- An Industry Perspective
  • Brief introduction to Cell and Gene Therapies
  • Unique challenges regarding R&D and Production
  • Current regulatory landscape and barrier
  • Interactive discussion and Audience Q&A

Special Session & Conference Highlight

The role of ICMRA in regulatory strengthening and convergence & Asia Training Center for Pharmaceutical and Medical Devices Regulatory Affairs (PMDA-ATC)

Session 2: Fostering Systems Strengthening and Regulatory Convergence

Presentations on the OpERA Initiative / Regulatory convergence in APEC / Industry Best Practices / Interactive Panel Discussion and audience Q&A

Coffee / Tea Break

Session 3: Focus on Pharmacovigilance

Presentations on What is Smart Safety Surveillance / Pilot experience / Industry Perspective / Discussion

Day 1 Wrap-up

Networking Reception

Location : Aloft Sentral Hotel Ballroom

Attendee Registration

Welcome Remarks by Advisory Board Co-Chairs

Robust Regulatory Frameworks as a Pillar of Universal Health Coverage (UHC)

Regulatory System Strengthening in Malaysia

Coffee / Tea Break

Session 1 : Introducing Regulatory Reliance

Patients’ Perspectives on Regulatory Reliance – A Moderated Panel Session

Why are patient engagement and advocacy efforts  important and how can regulatory efficiency be linked to improved health outcomes/UHC - A armchair discussion with Ratna Devi (IAPO Board member).

WHO Regulatory Systems Strengthening Activities: Focus on Reliance

Good regulatory and reliance practices; Global benchmarking process; Support to Regional Regulatory Initiatives (ASEAN)

Tools to Facilitate Regulatory Reliance & Review – Assessment reports, WHO CPP Scheme, GMP Inspections

Presentations on Reliance practices and improving public health / work-sharing / tools for implementation of reliance pathways / industry case study / interactive Panel discussion

Lunch & Learn Session (Optional)

Regulation of Cell & Gene Therapies- An Industry Perspective
  • Brief introduction to Cell and Gene Therapies
  • Unique challenges regarding R&D and Production
  • Current regulatory landscape and barrier
  • Interactive discussion and Audience Q&A

Special Session & Conference Highlight

The role of ICMRA in regulatory strengthening and convergence & Asia Training Center for Pharmaceutical and Medical Devices Regulatory Affairs (PMDA-ATC)

Session 2: Fostering Systems Strengthening and Regulatory Convergence

Presentations on the OpERA Initiative / Regulatory convergence in APEC / Industry Best Practices / Interactive Panel Discussion and audience Q&A

Coffee / Tea Break

Session 3: Focus on Pharmacovigilance

Presentations on What is Smart Safety Surveillance / Pilot experience / Industry Perspective / Discussion

Day 1 Wrap-up

Networking Reception

Location : Aloft Sentral Hotel Ballroom

Session 4: ICH in Asia

Presentation on Implementing reforms to build the future followed by an interactive panel discussion and audience Q&A

Coffee / Tea Break

Session 5: Supporting Regulatory Convergence in Asia

Presentations on Regulatory Convergence in APEC / best practices in the ASEAN region & future convergence plans / interactive panel discussion / audience Q&A

Lunch & Learn Session (Optional)

WHO post approval change guidance and ICH Q12 Principles - an Industry perspective

Session 6: Supporting Regulatory Convergence for Vaccines in Asia

Presentations on Vaccine Registration Harmonisation proposals / lot release testing in country for vaccines / Network of NCLs / interactive panel discussion /audience Q&A

Session 7: Innovative Solutions for a Safer Supply Chain

Presentations on new solutions to label, veriy, track and trace pharmaceutical products through the entires supply chain and the importance of interoperability and scalable, step-wise implementation, followed by an interactive panel discussion and audience Q&A

Conference Wrap-up and Interactive Discussion on 10th ARC Recommendations & Outcomes

Closing Remarks

IFPMA / PhAMA

Session 4: ICH in Asia

Presentation on Implementing reforms to build the future followed by an interactive panel discussion and audience Q&A

Coffee / Tea Break

Session 5: Supporting Regulatory Convergence in Asia

Presentations on Regulatory Convergence in APEC / best practices in the ASEAN region & future convergence plans / interactive panel discussion / audience Q&A

Lunch & Learn Session (Optional)

WHO post approval change guidance and ICH Q12 Principles - an Industry perspective

Session 6: Supporting Regulatory Convergence for Vaccines in Asia

Presentations on Vaccine Registration Harmonisation proposals / lot release testing in country for vaccines / Network of NCLs / interactive panel discussion /audience Q&A

Session 7: Innovative Solutions for a Safer Supply Chain

Presentations on new solutions to label, veriy, track and trace pharmaceutical products through the entires supply chain and the importance of interoperability and scalable, step-wise implementation, followed by an interactive panel discussion and audience Q&A

Conference Wrap-up and Interactive Discussion on 10th ARC Recommendations & Outcomes

Closing Remarks

IFPMA / PhAMA

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

Regulatory Consultant 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

Sarah Adam

Senior Manager for Regulatory and Scientific Affairs IFPMA

Advisory Board

Director, Biotherapeutics & Scientific Affairs IFPMA

Regulatory Science Committee Chair IFPMA

Executive Director CIRS

Secretary General CIOMS Lembit Rägo MD, PhD was born in Tartu, Estonia, in

Executive Director, Duke-NUS Senior Advisor, MOH  

Board Member IAPO (International Alliance of Patients Organizations)

Adjunct Professor & ICMRA Vice Chair TGA / ICMRA

Director NPRA (Malaysia)

Office Director of Office of International Cooperation PMDA

Group Lead Regulatory Networks and Harmonization [RNH] Regulatory Systems Strengthening [RSS] WHO

Venue

Hotel and Travels

Travel & Visa Information :

UPDATE: Participants are advised to carefully read WHO’s advice for international travel and trade in relation to the outbreak of pneumonia caused by a new coronavirus in China before making any travel arrangements. Please monitor the situation closely.

Most nationalities can enter in Malaysia without a visa for stays of up to a month.

Before traveling, make sure you are aware of what are the current requirements for your country and what type of visa, if any, you will need.

Invitation letters can be sent upon request. Should you need any additional VISA information, you can contact events@phama.org.my

 

Hotels:

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Le Méridien Kuala Lumpur
2 Jalan Stesen Sentral, Kuala Lumpur Sentral
Kuala Lumpur, 50470 Malaysia

hilton

Hilton Kuala Lumpur
3, Jalan Stesen Sentral
Kuala Lumpur, 50470 Malaysia

360927a_hb_a_002

Ascott Sentral Kuala Lumpur
No. 211, Jalan Tun Sambanthan
Kuala Lumpur, 50470 Malaysia

219877405

Alila Bangsar Kuala Lumpur
 58, Jalan Ang Seng, Brickfields
50470 Kuala Lumpur

24825_394850332560_7287495_n-848x494

Hotel Sentral Kuala Lumpur
No 30, Jalan Thambypilla Brickfields
50470 Kuala Lumpur