10th Asia Regulatory Conference

Date

4 - 5 November

Location

ALOFT KUALA LUMPUR SENTRAL HOTEL, KUALA LUMPUR, MALAYSIA

Conference Schedule / draft

Download Draft Schedule

Day 01
12.02.2020
Day 02
13.02.2020

Keynote Speeches
Session 1: Introducing regulatory reliance
Session 2: Fostering systems strengthening and regulatory convergence
Session 3: Focus on Pharmacovigilance
Full Day

08:00 - 09:00

Attendee Registration

09:00 - 09:20

Welcome Remarks by Advisory Board Co-Chairs

10:00 - 10:30

Coffee / Tea Break

10:30 - 13:00

Session 1 : Introducing Regulatory Reliance

Session Chair: Greg Perry, Assistant Director General, IFPMA

13:15 - 14:00

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

14:00 - 14:30

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)

14:30 - 15:30

Session 2: Fostering Systems Strengthening and RegulatoryConvergence

Session Chairs: Yasuhiro Fujiwara, PMDA& David Jefferys, IFPMA

15:30 - 16:00

Coffee / Tea Break

16:00 - 17:30

Session 3: Focus on Pharmacovigilance

Chair: Raj Long, Deputy Director, Integrated Development Global Health,Bill & Melinda Gates Foundation

17:30 - 17:45

Day 1 Wrap-up

18:30 - 20:00

Networking Reception

Location : Aloft Sentral Hotel Ballroom

08:00 - 09:00

Attendee Registration

09:00 - 09:20

Welcome Remarks by Advisory Board Co-Chairs

10:00 - 10:30

Coffee / Tea Break

10:30 - 13:00

Session 1 : Introducing Regulatory Reliance

Session Chair: Greg Perry, Assistant Director General, IFPMA

13:15 - 14:00

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

14:00 - 14:30

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)

14:30 - 15:30

Session 2: Fostering Systems Strengthening and RegulatoryConvergence

Session Chairs: Yasuhiro Fujiwara, PMDA& David Jefferys, IFPMA

16:00 - 17:30

Session 3: Focus on Pharmacovigilance

Chair: Raj Long, Deputy Director, Integrated Development Global Health,Bill & Melinda Gates Foundation

15:30 - 16:00

Coffee / Tea Break

17:30 - 17:45

Day 1 Wrap-up

18:30 - 20:00

Networking Reception

Location : Aloft Sentral Hotel Ballroom

Session 4: ICH in Asia
Session 5: Supporting Regulatory Convergence in Asia
Session 6: Supporting Regulatory Convergence for Vaccines in Asia
Session 7: Supply Chain
Full day

08:30 - 10:00

Session 4: ICH in Asia

Session Chair: Sharon Olmstead, IFPMA

10:00 - 10:30

Coffee / Tea Break

10:30 - 12:00

Session 5: Supporting Regulatory Convergence in Asia

12:15- 13:00

Lunch & Learn Session (Optional)

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

13:00 - 14:00

Session 6: Supporting Regulatory Convergence for Vaccines in Asia

Session Chair: Mic McGoldrick, IFPMA VSRWG

14:00 - 15:00

Session 7: Innovative Solutions for a Safer Supply Chain

Session Chair: Greg Perry, IFPMA

15:00 - 15:45

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

15:45 - 16:00

Closing Remarks

IFPMA / PhAMA

08:30 - 10:00

Session 4: ICH in Asia

Session Chair: Sharon Olmstead, IFPMA

10:00 - 10:30

Coffee / Tea Break

10:30 - 12:00

Session 5: Supporting Regulatory Convergence in Asia

12:15- 13:00

Lunch & Learn Session (Optional)

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

13:00 - 14:00

Session 6: Supporting Regulatory Convergence for Vaccines in Asia

Session Chair: Mic McGoldrick, IFPMA VSRWG

14:00 - 15:00

Session 7: Innovative Solutions for a Safer Supply Chain

Session Chair: Greg Perry, IFPMA

15:00 - 15:45

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

15:45 - 16:00

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

Janis Bernat

Director, Biotherapeutics & Scientific Affairs IFPMA

David Jefferys

Regulatory Science Committee Chair IFPMA

Neil McAuslane

Executive Director CIRS

Lembit Rägo

Secretary General CIOMS

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

Director NPRA (Malaysia)

Junko Sato

Office Director of Office of International Cooperation PMDA

Samvel Azatyan

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:

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

Hotel Website

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

Hotel Website

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

HOTEL WEBSITE

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

HOTEL WEBSITE

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

HOTEL WEBSITE