Supplying Medicines to Japan - Are you ready for a PMDA Inspection? Japan is now the 4th most Prolific Inspectorate Outside its own Borders

About this Course

INTRODUCTION

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
• Japan’s PMDA is now the 4th most active inspectorate outside its own borders. Only US FDA /EMA & Brazil make more overseas inspections

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.

WHO SHOULD ATTEND

This seminar will be of benefit to all personnel for whom Japan is important and includes the following work areas:

• Manufacturing
• QA of Drug Products or APIs
• Rationalisation and Site Transfer
• GMP Compliance
• Regulatory Affairs
• Project Planners
• Auditing of own Supplier Activities
• Logistics Interfaces

TOPICS TO BE COVERED AT THIS MEETING:

• Supply to Japan -Why is it so Difficult?
• The Mutual Recognition Agreement (MRA) Between Japan and the EU
• Revision of the Pharmaceutical Affairs Law (PAL)
• Preparing to Pass a PMDA Inspection
• Industry Inspection Experience
• What PMDA are Looking for in Theory and in Practice

Are you aware that:

• Japanese Foreign Inspections have Dramatically Increased in Number
• Even Products Covered by the MRA are Being Inspected
• If you Haven’t yet been Inspected by PMDA, you will be soon
• Japan Sees Quality Differently
• It is Really Important to Know What is in Your Application Form

Speaker:
Malcolm Holmes Pharmaceutical Quality / GMP Consultant, UK

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