SG PDA: Regulatory Workshop (Drug-Device Combination Products)

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About this Event

PDA Drug Device Combinations Regulatory Affairs Workshop is a workshop organized by PDA Singapore chapter to share best practices amongst industry professionals in the RA industry.

Agenda

🕑: 10:30 AM - 11:00 AM
Opening
Host: Samuel Tan (Novartis - PDA SG Chair), Crystal Lau (MSD)
🕑: 11:00 AM - 11:45 AM
Comparison of Reference HA Requirements & Framework for Combination Products
Host: Yu Liang (MSD)
🕑: 11:45 AM - 12:30 PM
Advancing Combination Products Development: Lessons from FDA GLP-1 Submissions
Host: Hendri Harmoko (BD)

Info: The global surge in GLP-1 therapies has placed disposable pens and auto-injectors under intensified regulatory scrutiny. This session translates recent US FDA queries on liraglutide and semaglutide ANDA submissions into actionable guidance for combination product developers.

Framed by the 21 CFR Part 4 Streamlined Approach, Dr. Harmoko will address the five gap areas FDA most often flags: comparative device performance data against the RLD, post-shipping and environmental testing, realistic data-driven specifications, complete risk and CAPA documentation, and Comparative Use Human Factors studies with aligned IFU/labeling.

🕑: 01:00 PM - 01:30 PM
ISO 13485 Expectations at Manufacturing Sites
Host: Miang Tanakasemsub (J&J)
🕑: 01:30 PM - 02:00 PM
Implementing a Risk-Based QMS: Harmonizing ISO 13485 and MDSAP Requirements
Host: Jocelyn Reyes

Info: Demystifying the Overlap: How to seamlessly map MDSAP (Medical Device Single Audit Program) requirements directly into your existing ISO 13485:2016 framework.
Practical Risk Integration: Key strategies for embedding risk management throughout your QMS without creating administrative gridlock.
The Multi-Jurisdiction Playbook: How Management Reps and QA leaders can leverage a single audit to satisfy diverse global regulatory expectations.

🕑: 02:15 PM - 02:45 PM
Lifecycle Management - Case Study
Host: Rama Sethuraman (Roche)

Info: This presentation will cover the life cycle management of Device-Drug combination products. This will include Pre-market submission requirements, essential requirements for safety and performance and the concepts of risk assessment under the Quality Management System (i.e., ISO 13485).

🕑: 02:45 PM - 03:15 PM
Notified Body Opinion Experience from The Industry
Host: Mike Wallenstein (Luminance Health)
🕑: 03:15 PM - 03:45 PM
Registration in EU Case Study: Pre-filled Syringe
Host: Hakima Bouslama (Efor)
🕑: 03:45 PM - 04:15 PM
Panel Discussion with Audience
Host: Speakers & Srinivasan N. Kellathur (Roche) as moderator
🕑: 04:15 PM - 04:30 PM
Closing Remarks
Host: Samuel Tan (Novartis - PDA SG Chair), Crystal Lau (MSD)