Japan Quality

Japan Quality

Heidelberg, Germany

Course No 9257


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Oliver Grosche, Elanco Animal Health
Dr Josef Hofer, EXDRA GmbH
Silke Mainka, Anwaltskanzlei Mainka
Werner Pelz, Carl Edelmann
Dr Armin Schweiger, Bayer Pharma AG

Objectives

It is the aim of this conference to point out which measures pharmaceutical companies and suppliers can take today so that the manufactured products achieve "Japan Quality" and can thus compete on the Japanese market. Among them are the sensitisation for "cosmetic" defects or the use of additional visual inspections.

This conference also gives an introduction to the cultural differences between Europe and Japan (Japanese mindset and behaviour, effective communication with Japanese business partners, precautions to avoid misunderstandings).

Furthermore, the general pharmaceutical bases (pharmaceutical legislation and authorities in Japan, Japanese Pharmacopoeia, GMP requirements in Japan) are presented, and the registration of medicinal products for a marketing authorisation in Japan is discussed.

Background

All pharmaceutical companies that deliver their products (starting materials, bulk and intermediate products as well as finished products) to Japan for the first time are familiar with the situation that the recipients and the customers of the market there complain about the delivered goods even though these products meet the agreed specifications. Soon it becomes clear that Japanese customers attach much more importance to the visual/outward appearance of goods than the average European or North American customer. The pharmaceutical environment has coined the term "Japan Quality" to describe this phenomenon.

Target Group

This conference is addressed to executives and employees from the pharmaceutical and its supplier industries who work in the fields of Regulatory Affairs, Research & Development, Quality Assurance, Quality Control or production and are involved in the manufacture and distribution of products for the Japanese market.

Programme

Regulatory Management for Japan
Management of Japan – specific requirements in Marketing Authorisation Procedures
Establishment of Regulatory Documentation for and from Japan, International Challenges
Japanese oriented Organisation and Structures in Drug Regulatory Affairs
Dr Josef Hofer

Regulatory Requirements in Japan
Japanese Pharmaceutical Authorities
Development of Japanese Pharmaceutical Law
Japanese System of Law
Revised Pharmaceutical Affairs Law (r-PAL)
GMP Regulations in Japan (J-GMP)
Dr Josef Hofer

Information on Cultural Differences between Europe and Japan
Country information
Japanese culture and mentality
General market behavior
Pharmaceuticals in Japan
Dr Oliver Grosche

Communication and Decision-Making Processes in Japanese Companies
High Context Culture
Communication Behaviour
Strength and Weaknesses
Silke Mainka

Legal Aspects from a Contract Manufacturer’s Point of View
Contractual situations
Impact of regulatory and other requirements on quality agreements
Mitigation of legal risks in supply agreements
Silke Mainka

How to Achieve „Japan Quality“ in a Pharmaceutical Company?
Product: customization to Japanese market
Process: continuous improvement using Kaizen, LeanSixSigma
Communication: awareness raising for Japanese business style
Dr Lars Sukowski

Specific Japan-Requirements Regarding Analytical Testing

Part I: General Overview
Pharmacopoeias in Japan (JP, JPE, JPC, JPED)
JP requirements on APIs and excipients
Specific requirements for analytical methods (method description, test procedure, method validation, specific Test methods)
Harmonisation

Part II: Dissolution Testing – A Key Analytical Tool for Product Performance and Bioequivalence
Regulatory background for dissolution testing
Standard experimental setup for Japan
Method development for new products
Method development for formulation changes
Comparison of product performance (Generics)
Dr Oliver Grosche

"Quality for the Japanese Market" - The Special Requirements for Secondary Packaging Material
General expectations to folding cartons and inserts
Defect evaluations of printing and finishing issues
Development of a defect list specification
Strategy of the packaging material producers
Realisation in the daily practice
Conclusions
Werner Pelz

„Japan Quality“ – Specific Requirements for Oral Solid Dosage Forms
Typical defects and their potential origin; defect classification from a Japanese point of view
Organisational measures in a multi purpose production environment
Potential improvement measures to minimize defect occurence
Opportunities and limitations associated with the use of automated inspcetion machines
Dr Armin Schweiger

„Japan Quality“ – Specific Requirements for
Liquid/Sterile Dosage Forms (Parenterals)
Case studies within Parenterals manufacturing
Implemented measures in aseptic production
Increasing requirements for primary packaging materials
Technical innovations in a brand new facility: Parenterals Production Kaiseraugst
Dr Lars Sukowski

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