Category Archives: 2026 Webinar and Seminar

Global Expert Seminar: Advancing Circular Healthcare Packaging: From Regulation to Practice

Date: 1 October  2026 (Thur)

Time: 9.00 pm – 1.00 pm

Venue: Iconic Marjorie Hotel, Penang

INTRODUCTION
The transition towards a circular economy is accelerating globally, with the European Union playing a leading role through the European Green Deal and its 2050 climate neutrality ambition. Within this framework, the Packaging and Packaging Waste Regulation (PPWR), in force since 11 February 2025, establishes a new baseline for packaging, introducing requirements on recyclability, recycled content, and reuse. These developments, together with evolving standards, are reshaping how packaging is designed and assessed, including in the healthcare sector.

This session will first set the policy and regulatory landscape, highlighting how EU legislation is driving a shift towards circular design principles in healthcare packaging.
Building on this foundation, the discussion will then connect policy with practice, focusing on collaborative initiatives across the value chain. Examples such as ENKORE and HPRC will illustrate how industry is addressing key challenges, particularly around end-of-life management.

The session will further explore:

• Latest developments in EU legislation and standardization
• End-of-life considerations, including hospital waste management practices, challenges, and regulatory barriers
• Pathways to adoption, such as the role of industry consortia in enabling scalable solutions.

Overall, the objective is to bridge policy, legislation, and practice, and to identify actionable pathways to advance circular healthcare packaging in a safe, compliant, and scalable way through collaboration.

COURSE OUTLINE
1. Latest developments in EU legislation and standardization.
2. End-of-life considerations, including hospital waste management practices, challenges, and regulatory barriers.
3. Pathways to adoption, such as the role of industry consortia in enabling scalable solutions.

Global Expert Seminar: Navigating European Market Access with CE Marking & Clinical Evaluation

Date: 10 September  2026 (Thur)

Time: 9.00 pm – 5.00 pm

Venue: Olive Tree Hotel, Penang

INTRODUCTION
As the European MedTech regulatory landscape continues to evolve, staying informed on the latest regulatory developments and clinical evidence requirements is essential for manufacturers seeking access to the European market.

This seminar features two focused sessions. The first provides an overview of the latest EU regulatory updates impacting CE marking, highlighting key regulatory developments and their implications for market access. The second explores Clinical Evaluation and provides an overview of ISO 14155, covering key concepts and current expectations.

Whether you work in regulatory affairs, clinical affairs, quality assurance, research and development, or product management, this seminar offers practical insights to help you stay up to date with evolving regulatory requirements and support your organization’s European market access journey.

COURSE OBJECTIVES
After participating in the seminar, you will be able to:

• Understand the latest EU regulatory updates related to CE marking.
• Gain an overview of ISO 14155 and clinical evaluation under the EU MDR.
• Learn the key elements of a clinical evaluation report (CER).
• Understand the Notified Body expectations for clinical evidence.

COURSE OUTLINE
1. EU Regulatory Updates for CE Marking
2. Clinical Evaluation & ISO 14155 Overview
3. Clinical Evaluation under EU MDR
4. Clinical Evaluation Report (CER)
5. MDR Notified Body Expectations for Clinical Evidence

Global Expert Webinar: Advancing Healthcare Innovation: Scaling SaMD in the Era of AI & Robotics

Date: 23 September  2026 (Wed)

Time: 3.00pm – 4.30pm

Online via Zoom Webinar

WEBINAR OUTLINES:

1. The Evolution of Software as a Medical Device (SaMD): Powering Intelligent Healthcare with AI & Robotics
2. Overview of SaMD and AI in Medical Devices Certification: Requirements & Pathways
3. Best Practices and Lessons Learned for SaMD and AI Devices in the Compliance Journey
   

EVENT OBJECTIVES:

• Position SaMD as a core pillar of next-generation healthcare innovation.
• Explore how AI enhances intelligence within SaMD, enabling predictive, personalized, and real-time care.
• Highlight the role of robotics as an enabler of software-driven healthcare delivery systems.
• Address key challenges around regulation, compliance, and scalability of SaMD solutions.

EXPECTED OUTCOMES:

• Clear understanding of SaMD regulatory frameworks and certification pathways.
• Insights into global regulatory trends and expectations from a notified body perspective.
• Practical knowledge of compliance requirements and best practices.
• Awareness of common challenges and strategies to overcome them.
• Enhanced readiness to initiate or streamline SaMD certification processes.