This Live Online Training 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.
Objectives
The purpose of this Live Online Training is to provide an overview on measures pharmaceutical companies and suppliers can take in order to achieve "Japan Quality" for their products.
The general pharmaceutical principles (pharmaceutical legislation and authorities in Japan, Japanese Pharmacopoeia, GMP requirements in Japan) as well as current developments will be presented and the registration of medicinal products for a marketing authorisation in Japan will be discussed.
Background All pharmaceutical companies that deliver their products to Japan for the first time are familiar with the situation that the recipients and the customers of the market complain about the delivered goods even though these products meet the agreed specifications.
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 phrase "Japan Quality" to describe this phenomenon.
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)
Specific Japan Requirements Regarding Analytical Testing
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
„Japan Quality“ – Requirements and Solutions for Oral Solid Dosage Forms
Typical defects and their potential origin
Defect classification from a Japanese point of view
Technical optimizations to minimize defects
Operational optimizations to minimize defects
„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
Strategies to reduce unnecessary rejects in visual inspection
„Quality for the Japanese Market“ – The Special Requirements for Secondary Packaging Materials
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
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT) ECA Members € 1,090 APIC Members € 1,190 Non-ECA Members € 1,290 EU GMP Inspectorates € 645 The fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Contacts: Questions regarding Content: Ms Sarah Schmidt (Operations Director), +49(0) 62 21/84 44 16, s.schmidt@concept-heidelberg.de
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