Attendees Registration

Opening Remark from Program co-Chair: Isao Sasaki, JPMA

Welcome speech– IFPMA Vice President: Isao Teshirogi

Key note speech (1)

Speaker: Samvel Azatyan, WHO
Regulatory System Strengthening – A global perspective
1) Good Regulatory Practices: developing principles and guidance to promote reliance, collaboration/networking and improved quality management
2) National Regulatory Authorities & Capacity Building: increasing transparency, benchmarking and establishing centers of excellence

Key note speech (2)

Speaker: Kazuhiko Mori, MHLW
Frontier Issues in Regulatory Science for Asia
Regulatory approaches on new technologies and innovative ways in drug review and proactive regulatory harmonization for Asian region

Break

Session 1

Good registration management to strengthen the product registration system in Asia – Regulator and Industry Views from APEC CoE Pilot Training –
Session Chair: John Lim, MoH Singapore/Duke-NUS CoRE

1) APEC RHSC Overview: Michelle Limoli, US FDA (10 min)

2) Product registration system in Chinese Taiwan and the training: Joyce Wang, TFDA (20 min)

3) JPMA’s activities to strengthen the registration system in Asia: Osamu Inagaki, JPMA (20 min)

4) Panel discussion (40 min)
Panelists: John Lim, Michelle Limoli, Joyce Wang, Osamu Inagaki, Junko Sato (PMDA), TS Lo (SAPI)
– future step(s) to disseminate the GRM within Asia
– how to overcome the review and submission issues to improve the registration process in Asia

Lunch

Session 2

International Council for Harmonisation
Session Chair: Petra Doerr, Swissmedic
1) Overview of the New Association
Speaker: Petra Doerr, Swissmedic (30 min)
Current ICH Membership and Observership
Communication/Stakeholder Engagement Framework and ICH Transparency Policy
ICH 2017 Work plan

2) Recent progress on ICH Guidelines
Speaker: Milton Bonelli, EMA (30 min)
Update on ICH Quality, Safety, Efficacy and Multidisciplinary Guidelines
New ICH topics / Future vision

3) ICH Training Strategy
Speaker: Michelle Limoli, US FDA (15 min)
ICH Training Strategy
Presentation of the first ICH training pilot

4) Engagement of IFPMA with ICH (15 min)
Speaker: David Jefferys, IFPMA
Role of IFPMA in ICH
IFPMA Representation in Asia

5) Q&A panel discussion: Impact in the Asian region (30 min)
Panelists: Petra Doerr, Swissmedic, Milton Bonelli, Michelle Limoli, David Jefferys, Yoonsook Lee, MFDS and Naoyuki Yasuda, MHLW/PMDA.

Break

Session 3

Global GMP Inspection Practice: Reality and Opportunities:
1) Introduction to session and speakers: Chair: Agnès Saint-Raymond, EMA (5 min)

2) GMP Inspectorates – global co-operation: Mark Birse, MHRA – UK (25 min)

3) GMP Landscape: Inspection metrics, trends, and submission support: Stephan Rönninger, EFPIA (15 min)

4) GMP Foreign Inspection: Malaysian Practice: Wan Othman Bin Wan Ismail , NPRA (15 min)

5) Q&A Panel discussion: led by Agnès Saint-Raymond, EMA Chair (25 min)

6) Key messages and Closing remarks by Chair: Agnès Saint-Raymond, EMA (5 min)
Program Day 2 (April 7, 2017)

End of Day 1

Key note speech (3)

Building a Twenty-first Century Pharmaceutical Regulatory System in China
Speaker: Chenguang Wang, Tsinghua Univ

1) To share progress/activities of China regulatory reform since last year

2) To update current discussion and debate on China DAL, Drug Administration Law and DRR, Drug Registration Regulation

3) To discuss how industry and academia can together in developing a drug regulatory system for the 21st century

Session 4

Life Cycle Management session -Reducing the Complexity of Variation Management to Enable Timely Access of Medicinal Products
Session Chair: Andrew Deavin, IFPMA

1) Introduction: Setting the scene. Andrew Deavin, IFPMA (10 min)

2) Industry view: An overview of the challenges facing industry to currently manage, approve and implement variations/changes to the registration particulars. Case studies will be used to illustrate the complexities encountered
Speaker: Sannie Chong, SAPI (25 min)

3) Regulator View: Reflections, experience and recommendations for improvements in variation management and global convergence
Speaker: Siti Aida Abdullah, National Pharmaceutical Regulatory Agency, Malaysia (25 min)

4) Panel Discussion: Discussion on the challenges and solutions to the points raised during the presentations. The following will be explored concerning reduction in complexity of variation management and the role of stakeholders including: industry; Asian Regulators and ASEAN harmonisation; and organisations such as WHO and ICH. Questions and discussion from the audience.
Chair: Andrew Deavin, IFPMA
Panelists: Sannie Chong, SAPI, David Jefferys, IFPMA, Yoshihiro Matsuda, PMDA, Siti Aida Abdullah, NPRA (30 min)

Break

Session 5

Regulatory convergence and promotion of work sharing in ASEAN
1) Introduction (Introduction by: Lo Thean Soo, SAPI) (5 min)

2) Way Forward in Addressing the Challenges with Country Specific Requirement (20 min)
Speaker: Salmah, MoH Malaysia
Topic Brief: To share current gap in implementation of ASEAN technical requirements noted from the “country specific requirement” project and the next step to close the inconsistency through joint assessment of the SIAHR project. To provide an update on WHO SIAHR (Supporting the Implementation of ASEAN Harmonized Requirements for Drug Registration) project and the ASEAN Joint Assessment initiatives.

3) Sharing Our Progress: The Upside and Downside ASEAN convergence (20 min)
Speaker: Tharnkamol Chanprapaph, ThaiFDA
Topic Brief: To share success story on ASEAN convergence and challenges arising from divergence (within ASEAN & Thailand)

4) Q&A, Panel discussion Session (30 min) (Moderated by: Jayanthi Boobalan, PhAMA)
Panelists: Salmah Bahri, MoH Malaysia, Tharnkamol Chanprapaph, ThaiFDA, Sannie Chong, SAPI, Dwiana Andayani, BPOM

Lunch

Session 6

Acceleration of the Regulatory Review Process for Innovative Medicines
Session Chair: Ian Hudson, MHRA

1) What expedited regulatory review means to patients – Kathy Gardiner, Patient Advocate (15 min)

2) The challenges and benefits in using expedited regulatory pathways, industry perspective – Alan Poirier, IFPMA (15 min)
US FDA Breakthrough Therapy Designation (TBD)
Compare and contrast US FDA BTD, EMA Priority Medicines, (PRIME) and Sakigake

3) Deep dive on MFDS legislation to support development and regulatory approval of innovative drugs – Yoonsook Lee, MFDS (15 min)

4) Impact of the new medicines approval process in Australia, regulator perspective
Expedited review and recognition of approvals in countries with comparable regulatory processes – Adrian Bootes, TGA (15 min)

5) Q&A panel discussion (Ian Hudson, MHRA, Kathy Gardiner, Patient Advocate, Alan Poirier, IFPMA, Yoonsook Lee, MFDS, Adrian Bootes, TGA, Agnes Saint Raymond, EMA) (25 min)

6) Closing remarks including wrap up of key messages (5 min)

Break

Closing panel discussion:

Overcoming regulatory hurdles in Asia
– Draw a picture of regulatory environment in Asia after 5 years –
Session Chair/co-chair: Toshi Tominaga, PMDA/Julie O’Brien, IFPMA

Summarize existing regulatory hurdles related to the ARC session topics and provide possible approaches to overcome these hurdles for future

Focus on the following session topics

Session 3: Global GMP inspection Practice

Session 4: Life Cycle Management

Session 6: Acceleration of the Regulatory Review Process for Innovative Medicines

Discuss the followings items
Overall agreement on goal image and existing regulatory hurdles
Practical proposals on each topic to overcome these hurdles
Required steps/actions for future

Summary of this session will be issued later as an Infographic
Panelists: Adrian Bootes, TGA, John Lim, CoRE/MoH Singapore, Mark Birse, MHRA, Sannie Chong, SAPI, Stephan Rönninger, EFPIA, Daisaku Sato, MHLW

Closing remark by Program co-Chair: Julie O’Brien, IFPMA

Conference Summary

End of Day 2