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Biotherapeutics

 

 

2019 APEC Harmonization Center Biotherapeutics Workshop

Biotherapeutics Roadmap 2012-2019: Gap Analysis and Assessment of Progress Made Towards Convergence

 

DRAFT v. July 19, 2019

September 3-4, 2019 (COEX Conference Room 300) | Seoul, Republic of Korea

The Biotherapeutics Roadmap was developed in 2012 with a goal to bringing into convergence the regulatory systems of APEC economies in the biotherapeutics space by 2020. Over the past 7 years, the APEC RHSC at the recommendations set forth in the Roadmap, hosted several workshops to assess the biotherapeutics regulatory gaps in the region; identified guidances that if implemented, would minimize these gaps; developed a curriculum for biotherapeutics; identified a Center of Excellence to train regulators; and developed key performance indicators to assess convergence. Now, in 2019, just one year away from the target goal of 2020, the APEC RHSC will recap the region’s progress towards that goal and envision the Roadmap beyond 2020

 

Time Topic
[Day 1]September 3, 2019
09:00-09:30 Arrival, Registration, and Networking
Welcome and Introduction
09:30-09:40 Opening Remarks AHC Director
Welcoming Remarks Roadmap Champion
Introductory: APEC RHSC 2020 Vision and the Accomplishment

Overview of RHSC 2020 Vision and the Strategic Apporaches; Share the results of the joint AHC-LSIF project to track key performance indicator (KPIs) measuring progress towards regulatory convergence in APEC region.

09:40-10:10 APEC RHSC 2020 Vision and the Strategic Apporaches RHSC
10:10-10:40 APEC Progress Towards Regulatory Convergence
Results from tracking the Key Performance Indicator(KPIs) and measuring progress towards regulatory convergence among APEC economies.
AHC
10:40-11:00 Group Photo & Break
Session I: APEC RHSC Biotherapeutics Roadmap

Overview of the Biotherapeutics roadmpa; Highlight major outcomes from the past 7 years' of roadmap activities including CoEs

11:00-11:30 Overview and History of the Biotherapeutic Roadmap
Roadmap Vision 2020, highlight the roadmamp activities in the past
MFDS
11:30-12:00 Center of Excellence (CoE)
Practical approach to build capacity in real world, sucessess and lessons learned
12:00-13:30 Lunch
Session II: Global Impacts of the APEC RHSC Biotherapeutics Roadmap

The impact from the work of Biotherapeutics Roadmap in development and adapation of the global guidelines as well as leveraging initial concept of regulatory capacity-building

Chair: TBD

13:30-16:50 1. WHO guideline of the Life Cycle Management for the Biologics
2. ICH guideline
   - Industry perspectives of how convergence and alignment to ICH guidelines has
     progressed in the past 10 years
3. Other global outreach efforts
16:50-17:00 Wrap Up for Day1
[Day 2] September 4, 2019
Session III, Part A: Evolving the APEC Biotherapeutics Roadmap

Considerations for broadening scope of work areas in Biotherapeutics and Emerging Technologies PWA

Chair: TBD

09:30-12:00 1. 3D hybrid Bio printing Technology for Artiicial Organ regeneration
2. Drug-binding clone antibodies
3. Medical device coated with drug/biologicals
   1) drug/biological product delivered with a device
   2) drug/biological product use in tandem with a software
12:00-13:30 Lunch
Session III, Part B: Evolution of the APEC Biotherapeutics Roadmap

Working together with other PWAs and navigating the overlap

Chair: TBD

13:30-15:00 1. Risk Management Plan
2. CMC & GMP Inspection
3. MRCT
4. PV
Session IV: [Panel Discussion] Pre-assessment of the APEC regulatory convergence in Biotherpaeutics
 

Moderator: TBD

15:00-16:00 [Panel Discussion] Real-time survey on Biotherapeutics regulatory status with the APEC regulatory authorities
16:00-16:20 Wrap up: Highlight of the workshop and next steps
16:30-16:45 Closing Remark AHC Director