We are delighted to see your interest in Freyr’s Webinar Series (FWS). The webinar on, “ASEAN Regulatory Strategy: Medical Devices”, is scheduled on March 10, 2021, for AMR, EU & ROW regions.

What Is It All About?

Medical devices organizations willing to launch their products in ASEAN geographies have to walk through stringent regulations. As different markets have varied Regulatory requirements and constantly changing medical device regulations, organizations tend to face Regulatory roadblocks. However, following an effective country or region-specific Regulatory strategy is the driving force for a compliant market-entry and will avoid high Regulatory costs, far stretched timelines, unexpected product changes and operational challenges. Why do organizations need a Regulatory strategy? What are the ASEAN Medtech and Regulatory market scenarios?

To help you understand the ASEAN Regulatory strategy, Freyr brings you a comprehensive webinar on:

ASEAN Regulatory Strategy:
Medical Devices

March 10, 2021

Duration - 45 Minutes

Join the Webinar at your Convenient Time

For AMR and EU Regions

10:00 AM EST | 4:00 PM CET

For RoW Region

11:30 AM IST

Host

Rahul Verma

Senior Manager, Regulatory Strategy

Rahul Verma is a Regulatory professional with over 8+ years of experience in Life Sciences industry and with a focus on strategic Regulatory and Business analysis of domestic and global markets. His core strength lies in executing strategic projects for global medical device clients and to support their Regulatory and product development decisions. With diverse Regulatory expertise, Rahul has supported numerous clients to achieve their global access and market-entry goals, with tactical and strategic solutions.

Presenter

Zulkhurnain Utar

Associate Director, RA

Zulkhurnain Utar is a professional Regulatory Subject Matter Expert, with more than 15 years of experience in regional Regulatory affairs and solutions in various regulated industries, including, medical devices/ pharmaceuticals/ consumer products. Besides having an extensive Research & Development experience, particularly in preclinical toxicology, he is competent and knowledgeable in FDA’s Quality Systems Regulations, EU Medical Device Regulations (MDR 2017/745 & IVDR 2017/746, MDD 93/42/EEC), QMS ISO 13485, ISO 14971 Medical Devices Risk Management, Conformity Assessment & CE Marking, Biocompatibility Testing ISO 10993, HACCP and Codex Alimentarius for food, Good Clinical Practice (GCP) and GHS for chemicals.

In this webinar, our in-house Regulatory experts – Zulkhurnain Utar, Associate Director, RA - Malaysia and Rahul Verma, Senior Manager, Regulatory Strategy, will elaborate on:

  • Why Regulatory strategy must be part of corporate strategy?
  • ASEAN Medtech Market and Regulatory scenario
  • Factors influencing ASEAN Regulatory strategy
  • Importance of country-specific Regulatory connect
  • Freyr’s strategic framework
  • Merging compliance with cost-effective strategic approach (includes, clinical, testing and QMS components)
  • Key takeaways from the session

Given the keynotes and with due respect to your busy schedule, we really look forward to seeing you in the webinar. Register now! Stay informed. Stay compliant.