Target Group
Objectives
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
- 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
- Japanese pharmaceutical authorities
- Development of Japanese pharmaceutical law
- Japanese system of law
- Revised pharmaceutical affairs law (r-PAL)
- GMP regulations in Japan (J-GMP)
- 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
- Typical defects and their potential origin
- Defect classification from a Japanese point of view
- Technical optimizations to minimize defects
- Operational optimizations to minimize defects
- Case studies within Parenterals manufacturing
- Implemented measures in aseptic production
- Increasing requirements for primary packaging materials
- Strategies to reduce unnecessary rejects in visual inspection
- 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
Questions regarding Organisation:
Ms Manuela Luckhaupt (Organisation Manager), +49(0) 62 21/84 44 66, luckhaupt@concept-heidelberg.de
Date & Time
This training/webinar cannot be booked. Send us your inquiry by using the following contact form.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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