Japan Quality

Japan Quality

Heidelberg, Germany

Course No 15460


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, Law Firm Mainka


Werner Pelz, Carl Edelmann

Dr Lars Sukowski, F. Hoffmann-La Roche

Dr Markus Wirges, 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
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)
Information on Cultural Differences between Europe and Japan
  • Country information
  • Japanese culture and mentality
  • General market behaviour
  • Pharmaceuticals in Japan
Communication and Decision-Making Processes in Japanese Companies
  • High Context Culture
  • Communication Behaviour
  • Strength and Weaknesses
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
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
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)
"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
„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 occurrence
  • Opportunities and limitations associated with the use of automated inspection machines
„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

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