SUPPLYING JAPAN ~
INSPECTION READINESS

Conference Date: 11-12 May 2009
Conference Ref: M5-6309
Fee: £1240 + VAT
Venue: The Cavendish Hotel, London

The Japanese Pharmaceutical Market is the second largest individual market in the world with a value of US $ 58.5 Billion. Recent changes in the Pharmaceutical Affairs Law (PAL) have facilitated direct supply by international Pharma companies. This combined with a lack of availability of many leading international products, creates an opportunity for companies wishing either to improve their market share or to supply Japan for the first time. 

The Japanese Authorities never used to inspect pharma facilities outside of Japan. With the revision of the PAL this changed: 

• Overseas Pharma Production Facilities are now subject to the same inspection requirements as Japanese based facilities.
• An Inspection is likely to be triggered by a change in an existing submission or by making a submission for a new product
• Are you prepared?
• Do you know what the PMDA expectations are both prior and during inspections?
• Do you know when and how you will receive both the informal and formal inspections findings?
• Do you know the requirements and time scales for your response following any observations made?

This seminar will provide you with:

• An overview of the PMDA inspection requirements.
• Guidance as to likely inspection targets, management of the inspection itself and how to follow up.
• Details of industry experience with PMDA inspections common areas of failure and what you can do to avoid them