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)

Info: This presentation provides a comparative overview of regulatory frameworks for drug–device combination products across major markets, including the United States and the European Union, alongside key Asia-Pacific (APAC) jurisdictions. It aims to provoke discussion on best practices within a diverse and evolving global landscape, and to explore an optimal, efficient regulatory framework for these products in APAC.

🕑: 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.3485 Expectations at Manufacturing Sites: Drug–Device Combination Products
Host: Miang Tanakasemsub (J&J)

Info: This presentation will offer a strategic and forward-looking perspective on how quality management systems must evolve to support the increasing complexity of combination product manufacturing. Beyond outlining core expectations across design transfer, production controls, supplier oversight, and process validation, it will examine how organisations can effectively integrate pharmaceutical and medical device quality frameworks to enable consistent, compliant, and scalable operations. The session will further explore emerging regulatory expectations and inspectional trends, highlighting common systemic gaps and the broader implications for leadership accountability, governance, and cross-functional alignment. Drawing on real-world insights, it will provide practical considerations and best practices for building resilient, inspection-ready manufacturing systems that not only meet compliance requirement but also drive operational excellence and patient-centric outcomes.

🕑: 01:30 PM - 02:00 PM
Implementing a Risk-Based QMS: Harmonizing ISO 13485 and MDSAP Requirements
Host: Jocelyn Reyes (TUV)

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
First Notified Body Opinions Under Article 117
Host: Mike Wallenstein (Luminance Health)

Info: The first wave of Notified Body Opinions under Article 117 has reshaped expectations for integral drug–device combination products in Europe. Early experience has shown that many sponsors underestimated the depth of MDR evidence required for the device constituent part, particularly in relation to GSPR conformity, risk management, human factors, and technical documentation structure. The speaker will share his experience related to deliverables, timing and costs related to Notified body opinions.

🕑: 03:15 PM - 03:45 PM
Registration in EU Case Study: Pre-filled Syringe
Host: Hakima Bouslama (Efor)

Info: In an EU environment, pre‑filled syringes are framed as Category‑1, integral drug–device combinations: authorized as medicinal products under 2001/83/EC/726/2004, while demonstrating MDR Annex I GSPR compliance for the syringe. Article 117, EMA/NCA–notified body collaboration, and robust, harmonized technical documentation for both drug and device components are central to a credible, approval‑ready development and registration strategy.

🕑: 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)