Healthcare Regulation in Japan and the UK 4th Japan-UK Life Science Seminar

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Monday 26 October, 2009
Co-organiser UK Trade & Investment
Co-organiser: Asia Pacific  Technology Network

This is the fourth in the “Japan/UK Life  Science Seminar Series” organised by the UK Trade & Investment and the Asia Pacific  Technology Network.  These quarterly seminars will provide an opportunity for UK  and Japanese companies in the pharmaceutical, biotechnology  and healthcare sectors to network, develop commercial ties and understand one another’s markets better.  

Chairs

• Anil Vaidya, Sector Specialist-Biotechnology & Healthcare: Far East & Asia Pacific, UK Trade & Investment
• John T Kelly, Managing Director, Moffat Dickson Ltd

Speakers

• Alan Wenman - Medical Device Managment
  • The Japanese Medical Device Regulatory Environment
• Derval O'Carroll - Director, Real Regulatory
  • The UK Medical Device Market
• Dr Findlay Walker,Vice President and Managing Director of Daiichi Sankyo Development Ltd
  • "Becoming a Global Pharmaceutical Company: The Daiichi Sankyo Experience"

Location: Department for Business Conference Centre, 1 Victoria  Street, London, SW1H 0ET
Nearest tube stations: St James Park or Westminster
Timing: Registration at 17.30: Session at 18.00: Networking and refreshments 19.45: finish 21.00
Pricing: £20 + VAT
Dr J. Findlay Walker

Findlay Walker is a 1967 graduate in Medicine from the University of Aberdeen, Scotland. After spending several years in training and practice in the UK he joined the pharmaceutical industry, In 1977 he joined Merck and Co, Inc., where he mainly working on projects related to hypertension and atherosclerosis. He joined Sankyo Pharma Development as Senior Director of Clinical Development in April 2002. He has been Vice President and Managing Director of Daiichi Sankyo Development Ltd., in Gerrards Cross for almost three years. The office is the European head office for drug development.

Alan Wenman
Alan has worked in the medical device industry since 1976 and joined BOC Medical (Ohmeda) as a design engineer before progressing to management roles in Manufacturing and Production Engineering as well as Quality Assurance. Ohmeda specialised in oxygen delivery, anaesthesia equipment, breathing circuits, suction equipment as well as patient monitoring.

Alan subsequently joined SMS Technologies a contract design and manufacturing company specialising in medical devices. Alan was responsible for Quality, Regulatory Affairs, Production Engineering, Research and Design. The company, under Alan’s direction, obtained ISO 13485 and CE certification for a range of medical devices as well as US 510(k) approvals.

In 2000 Alan founded Medical Device Management Ltd (MDM) a consultancy company whos objective was to help clients obtain quality and regulatory approvals for Medical Devices. MDM has itself achieved Canadian as well as European approvals to ISO 13485:2003 and Alan was certified by Health Canada as an auditor for ISO 13485:2003. MDM also holds CE certificates under annex ll for a range of medical devices including Depth of Anaesthesia Monitors and has been successfully audited by BSi for compliance to the Japanese regulatory requirements.

As consultants MDM has assisted clients in obtaining ISO 9001 and ISO 13485 certification as well as CE marking for medical Devices, TGA approval, Wholesalers Dealers licences for medicinal products and FDA 510(k) approvals.

Medical Device Management is also certified by BSI to EN 13485 for consultancy services relating to Medical Devices and operates a manufacturing service for other medical device manufacturers.

As a manufacturer MDM supplies equipment worldwide including significant success in the Japanese market following the launch of the aepEX depth of anaesthesia monitor.