The Emergo Team in Asia Pacific
Emergo Group maintains its offices throughout North and South America , the Asia Pacific region, Europe and the Middle East. Shown below is a selected list of consultants and employees based in our offices in Australia and Japan.
AUSTRALIA
SKALSKY Ph.D, Mike - Director, Emergo Australia (Sydney)
Mike serves as Director of Emergo Australia in Sydney. He brings many years of experience in the medical devices industry, helping companies to develop their products as well as formulating market entry and business development programs. He has intimate knowledge of the medical technology product development and commercialization process having taken several device products from concept through clinical trials and regulatory approval. Mike also serves as the primary liaison between Emergo's Sponsor representation clients and the Therapeutic Goods Administration (TGA) in Canberra. He is frequently in contact with the TGA and often assists Emergo clients with regulatory, quality assurance, classification and registration issues. Education: MBA (Exec), Australian Graduate School of Management, University of New South Whales (UNSW); Postgraduate Diploma in Management, Australian Graduate School of Management, UNSW; Certificate in Project Management, Australian Institute of Management; PhD in Chemical/Biomedical Engineering, UNSW; BE in Honours I Chemical Engineering, UNSW.
JAPAN
AONO Ph.D, Hiroyuki - Senior Consultant, IVD Devices (Tokyo)
With more than three decades of experience in regulatory affairs and quality assurance, Dr. Aono brings a wealth of knowledge to Emergo clients selling international markets, especially Japan. Prior to joining Emergo, Dr. Aono was a Senior Regulatory Consultant in the medical device and IVD consulting division of KPMG in Tokyo where he assisted clients with submissions to the Japanese PMDA. Before KPMG, Dr. Aono was with Hitachi Medical Systems where he managed quality system compliance and auditing for the medical division. Much of Dr. Aono's career was spent with Tokoyama, a respected Japanese manufacturer of IVD chemical reagents. Among other things, he ensured that Tokoyama's quality management system was in compliance with the Pharmaceutical Affairs Law (PAL), performed numerous audits and was heavily involved in many technology transfer projects for the company. In addition to his vast knowledge of Japanese regulations, he is also very familiar with European CE Marking for IVD products.
CHUJO, Atsushi - Quality Assurance & Regulatory Affairs (Tokyo)
Atsushi Chujo is a Specialist in the Emergo Japan K.K. office in Tokyo. Prior to joining Emergo, he was with the medical device consulting division of KPMG in Tokyo, assisting Japanese medical device manufacturers with regulatory and quality assurance issues. Mr. Chujo brings Emergo Japan an extensive knowledge of biologics and holds a Masters Degree in the area. Prior to joining Emergo, he spent one year working on vaccines for a well known international pharmaceutical company and three years with Regenerative Medical Products, a manufacturer of human cell tissue products used during eye surgery. His role at Regenerative Medical Products was to maintain the quality control and he brings his knowledge of biologics, manufacturing, regulatory and quality control issues to the Emergo Japan team.
HASEGAWA, Tomoki - Director, Clinical Management Service / DMAH Service Division (Tokyo)
Tomoki Hasegawa oversees Emergo Japan's DMAH and clinical trial management services. He has significant experience in the medical device and IVD industry, gained from previous work at Baxter, Tyco Healthcare, Maque and Third Wave Japan. During that time, Tomoki held managerial positions, including qualified general manager, quality manager and safety manager according to Japanese PAL. Tomoki is also a licensed registered pharmacist. Education: Master of MOT (Management of Science and Technology), Tokyo Science of University; BA in Pharmacy, Gifu Pharmaceutical University.
ITAGAKI, Minako - Administrative Assistant (Tokyo)
If you call the Japan office, Minako Itagaki is likely the first voice you will hear. Prior to joining Emergo Japan, she worked at a French printing device manufacturer and handled trading work, including ordering and customs clearance. She also worked at a polizer trading company as an assistant of foreign sales affairs. Education: BA in Foreign Languages, Kanda University of International Studies.
MAKABE, Yuichi - Director & Chief Operating Officer, Emergo Japan (Tokyo)
Yuichi Makabe has a long history in the medical devices industry and is especially knowledgeable in the areas of orthopedics and dental products. Prior to becoming the COO of the Emergo Japan K.K. office in Tokyo, Mr. Makabe oversaw the compilation of Japanese Pre-Market Approval, Certification and Submission documents for the medical device consulting division of KPMG in Tokyo. His experience at KPMG was preceded by more than 25 years working for an orthopedics and dental devices manufacturer in Tokyo where he managed sales, marketing and regulatory affairs. During his career, Mr. Makabe has successfully obtained PMDA approval for many medical devices, including several high risk devices. Today, he provides guidance to the Emergo Japan consulting team, offers senior consulting support to Emergo Japan clients and oversees the day to day operations of the Tokyo office.
MIYAHARA, Michiharu - President & CEO, Emergo Japan (Tokyo)
Michiharu Miyahara is the President and CEO of Emergo Japan K.K. in Tokyo and oversees all operations in the country. Mr. Miyahara has more than 20 years of experience with quality assurance and regulatory issues facing medical device manufacturers selling in Japan. Mr. Miyahara was the Director of the Regulatory Affairs and Quality Assurance Advisory Service Group consulting division of KPMG in Tokyo, a division he started within KPMG in 1995 and became the leading consulting firm in Japan. On October 1, 2008, this KPMG division merged with Emergo Japan which Mr. Miyahara now spearheads.
SAITO, Noriko - Senior Consultant, Regulatory Affairs, Medical Devices (Tokyo)
Noriko Saito has many years of regulatory consulting experience at a Japanese legal consulting firm and has assisted numerous medical device companies. Prior to joining Emergo Japan, Noriko worked at Philips Medical Systems and AZE Ltd., specializing in medical imaging systems. She also has experience with translating technical documents for medical devices and clinical data. Education: English Literature, Waseda University; University of California Berkeley for studying English.
SAKAMAKI, Aika - IVD Specialist, Regulatory Affairs (Tokyo)
Aika Sakamaki assists with medical device registrations and clinical trial management projects. As a registered pharmacist, Aika brings to Emergo Japan significant experience in the medical field through her previous work in hospitals. Education: BA in Pharmacy, Hoshi University.
TASAKI, Kiyoshi - Senior Consultant, Japanese Quality Assurance (Tokyo)
Kiyoshi Tasaki is based in the Emergo Japan office in Tokyo and brings a wealth of medical device quality system management experience to the Emergo team. Prior to joining Emergo Japan, he spent several years with the medical device consulting division of KPMG in Tokyo. His experience at KPMG was preceded by nearly eight years working on ISO quality system implementation and management for large building maintenance services company. Mr. Tasaki is a licensed international quality systems auditor certified by the JRCA and is very knowledgeable about Japan quality systems regulations, ISO 13485 and GMP. He also prepares technical documentation and plays an active role in obtaining new device approvals and certifications from the Japanese Pharmaceutical & Medical Devices Agency (PMDA) and local prefectural governments in Japan.
YASHIRO, Kenji - Senior Consultant, Japanese Regulatory Affairs (Tokyo)
With a background in engineering and experience in medical device distribution, Kenji Yashiro has been exposed to many facets of the medical device manufacturing and sales process, from device conception to final distribution to the end user. He uses this experience for the benefit of Emergo clients wishing to enter the Japanese market. Based in Emergo's office in Tokyo, Mr. Yashiro spent nearly two years with KPMG's medical device consulting division in Tokyo. His prior experience as a design, process and quality engineer at one of Japan's most respected manufacturers of sterile needles and catheters gave him an in-depth understanding of the manufacturing and quality control process. He also spent time working for a medical device distributor specializing in respiratory, digestive surgery and fertility treatment products. In his role as a Senior Consultant with Emergo Japan, Mr. Yashiro assists clients with Japanese Pre-Market Application (PMA) preparation and other quality assurance and regulatory issues.
