Medical Device Regulatory Updates For Major Markets & Clinical Trials For IVD

Fiametta S. Soenardi, Senior Consultant / Chief of Operations, Sixmurs Group Fiametta S. Soenardi has more than total of 20 years of experience in Quality Assurance, Quality Systems, Manufacturing and Regulatory Affairs. She holds a Bachelor Degree in Food Technology from Bogor Agricultural University, Indonesia and MBA from Prasetiya Mulya Busines School, Indonesia. Fiametta has previously worked for Procter & Gamble Indonesia, where she took care of QA, Quality System and Production and subsequently transferred to the position of Technical External Relations at PT Procter & Gamble Home Products Indonesia during her 10 years of service. After Procter & Gamble, Fiametta joined PT Johnson & Johnson Indonesia (Medical Division) as Regulatory Affairs Manager and she held the position of Associate Director, Regulatory Strategy and Policy for Pakistan & ASEAN. She left J&J to start up Sixmurs Group of Companies, which provides end-to-end value chain service for healthcare businesses (covering pharmaceutical, dietary supplements, medical device, cosmetics and household devices) who wish to enter ASEAN countries. As Chief of Operations in the Group , she is involved in managing healthcare products commercialization and launching, starting from managing approval for clinical evaluation (including First in Man Study) up to the point of importation.
Eric Lam, Regulatory & Compliance Director, QARA Consultancy Ltd Eric has more than 20 years of working experience in the regulatory field in China. He spent 14 years on product compliance and another 8 years on medical device and food contact regulatory compliance in the Asia Pacific region. Prior to setting up his company (QARA Consultancy Ltd), Eric has worked in various Multinational Companies (MNCs) to support the regulatory approvals for access to China. Mainly focus on medical devices like thermometer and Blood Pressure Monitor. Success +50 medical device projects registration in AP, +10 medical device projects for CFDA. Eric’s has a BSc (Hons) in Industrial Quality Management.
Danielle Giroud, Founder, MD-Clinicals, Lausanne-Beijing With over 25 years of experience, Ms. Giroud is founder and senior faculty board member of the World Medical Device Organization (WMDO), an independent professional organization dedicated exclusively to serving the professional development and educational needs of medical device professionals from around the world. Since 2013, Mrs. Giroud also founded MD-CLINICALS, a 100% medical device dedicated Clinical Research Organization with main activities in the Asia Pacific, South American, European and Middle East countries. Serving medical device manufacturers from around the globe with high quality clinical research and regulatory services and supporting them getting their products to the target markets. Ms. Giroud is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe. She is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO 14155 as well as liaison with the EU Commission - CIE (Clinical Investigation and Evaluation) task force.
Hwee Ee Tan, Principal Consultant/Director, DH RegSys Pte Ltd HweeEe has more than 25 years of experience in the medical device industry and worked in manufacturing as Engineer and also in Senior Management roles in QA / RA. She also worked as a Consultant in a Pharma/Device consultancy company. In 2010, HweeEe founded DH RegSys Pte Ltd to provide advisory services to the medical device industry with focus on Regulatory Affairs and Quality Management Systems. During the past few years, the consultancy services have expanded to include providing regulatory support for medical device clinical trials in China and the region. HweeEe provides training on both Regulatory and QMS (eg ISO13485 and compliance to 21CFR Part 820). She is a member of Asian Harmonization Work Party (AHWP); Working Group 6 (WG6) Quality Management Systems: Audit & Assessment.