Considerations in application outsourcing and use of eCTD And consider issues that the discussion of outsourcing criteria Considerations in application outsourcing and use of eCTD
Seminar explains the advantages and disadvantages of outsourcing and in-house!Sign up for seminarsOverview
In this seminar, eCTD explain the basis of the considerations and benefits of outsourcing to external contractors, will explain the process of approval based on preliminary application.Sun ConferenceApril 18, 2011 (Mon) 13:00 - 16:30Audience
* ECTD support personnel
* ECTD compliant when in-house, who want to understand the point of outsourcing isolation
* ECTD related technicians, developers
Knowledge acquisition
* ECTD Basics
* ECTD in-house and outsourced benefits and disadvantages
* ECTD point when you outsource
* ECTD preparation needed to apply
Regulation-related regulations
* Food Review No. 3, 0707 from Mr. Drug Administration Pharmaceutical and Food Safety Bureau Ministry of Health review (July 7, 2009)
"The electronic Common Technical Document Specification (Version 3.2.2)"
No. 0401022 * Development of Ministry of Health, pharmaceutical and food diet drug director Satoshi Tooru (April 1, 2005)
"On the use of electromagnetic records and electronic signatures in the application pertaining to such approval or authorization of pharmaceutical products"
Program
If you make eCTD filing an NDA application, filing the attached document (CTD) of the attachment by eliminating the third part of the fifth, in the pharmaceutical industry has had great benefits but, eCTD to make itself one is a challenge. This eCTD generation, may be commissioned to conduct our own in-house and external.Each merit, but disadvantages in this course is to explain the process to approval based on preliminary considerations apply to the benefits of outsourcing and external contractors mostly.The commentary will also consider other matters that require minimal in-house.
1. ECTD and
1. ECTD History
2. ECTD Configuration
3. ECTD creating
4. ECTD Regulatory Considerations in the Application
2. ECTD creation and outsourcing of its own
1. ECTD to prepare for the introduction
2. To create its own advantages and disadvantages of outsourcing
1. Pros and Cons of approval
2. Advantages and Disadvantages of non-approval
3. Factor in deciding their own creation and outsourcing
4. Considerations when outsourcing
5. Considerations when outsourcing
3. ECTD preparation for the application
1. Materials (documents) prepared in the preparation
2. Materials (documents) prepared in the management
3. ER / ES to support
4. Support in the organizational structure
5. Other Considerations
* Exchange business cards Q & A
Lecturer
Janssen (Ltd.) Director of Regulatory Affairs Division,Subcommittee head computerized information for Drug Evaluation Committee before the Japan Pharmaceutical Manufacturers AssociationJapan Pharmaceutical Manufacturers Association before the project board ICH Topic M2 ReaderPublic Wear NPO Organization (MIST) CouncilMr. Adati TakeshiCareer
Pharmacist, MBA.After graduating from the Faculty of Pharmaceutical Sciences, Kanazawa University, he joined the pharmaceutical industry investment in the laboratory, a researcher engaged in analytical chemistry.In addition to research activities during this analysis LIMS (Laboratory Information Management System) also deals with construction.Then transferred to pharmaceutical business development, including foreign pharmaceutical companies undertake the review of new drug approval for about 15 years.Also, during this period, safety and operations also experienced post-marketing surveillance.Industry activities, the former Committee on ESMI Japan Pharmaceutical Manufacturers Association (now Electronic Information Division) engaged in various activities in the eCTD for the introduction of a national.The NPO also wear Organization who is also a public director.Isao Makoto on the subject, etc.
* ECTD Japanese Local Guidance: 5th Annual Workshop in Japan for Medical Information Processing DIA, 2004
Intermediate study of electronic standards * Japan Pharmaceutical Manufacturers Association, Information Management Division the opportunity to co-University Hospital in Takamatsu, 2008
* Current standards for electronic document management in clinical trials, 3rd MIST Symposium, 2008
* Current state of electrons in the pharmaceutical industry 4th MIST Symposium, 2008
* Direction of Computerization in Pharmaceutical Development; The 6th Annual Japan DIA Meeting 2009
Electronic and other drug development, eCTD many lectures on the relationshipSpecial discounts for several people simultaneously take
* Per person if two people participated in 7,350 yen discount
* Per person discount when participating in three 10,500 yen (limited to the same corporation)
VenueShinko KaikanShibakouen 3-5-8, Minato-ku
Floor Room No. 6 6D-3Sponsored byScience & Technology Co., Ltd.Payment, whether or not to cancel, thank you to always check before you apply.Contact UsInquiries about this seminar, thank you from the tech-seminar.jp inquiry.(Contact us directly to the organizer Please refrain.)Fees (tax included)Solo: 42,000 yenSeveral people: 34,650 yenSign up for seminarsPresentation order program are subject to change. Please note.
* CTD (Common Technical Document)
* Drugs
Relevant seminars / relevant publicationsMotomu Kaname differences based on very efficient 3 CMC expertise to create the required application materials and information containedPharmacokinetics ("F" section) and ensure data in the study to ensure reliability of test methods QC · QA / TimingNDA dossier for creating data / assurance and testing to ensure reliability check method QC · QA / TimingPharmacology study ("E" section) to ensure reliability and assurance in check method QC · QA / TimingQuality ("b", "C" section) to ensure high reliability of the test method QC · QA check / TimingBased on drug GMP ~ 3-pole responseTrial QC / QA ~ GCP Taking into account the assessment of suitability issues identified -DMF and thorough comparison of the three regions of CTD M3 shown how to reflect the relevance of preparationCTD clinical study report on the minimum you need to know to create knowledge and statisticsAntibody (bio) pharmaceutical expertise CMC / review the application and the matters inquired into the actual response
For More information in Japanese Language Please Click : Japan eCTD
Seminar explains the advantages and disadvantages of outsourcing and in-house!Sign up for seminarsOverview
In this seminar, eCTD explain the basis of the considerations and benefits of outsourcing to external contractors, will explain the process of approval based on preliminary application.Sun ConferenceApril 18, 2011 (Mon) 13:00 - 16:30Audience
* ECTD support personnel
* ECTD compliant when in-house, who want to understand the point of outsourcing isolation
* ECTD related technicians, developers
Knowledge acquisition
* ECTD Basics
* ECTD in-house and outsourced benefits and disadvantages
* ECTD point when you outsource
* ECTD preparation needed to apply
Regulation-related regulations
* Food Review No. 3, 0707 from Mr. Drug Administration Pharmaceutical and Food Safety Bureau Ministry of Health review (July 7, 2009)
"The electronic Common Technical Document Specification (Version 3.2.2)"
No. 0401022 * Development of Ministry of Health, pharmaceutical and food diet drug director Satoshi Tooru (April 1, 2005)
"On the use of electromagnetic records and electronic signatures in the application pertaining to such approval or authorization of pharmaceutical products"
Program
If you make eCTD filing an NDA application, filing the attached document (CTD) of the attachment by eliminating the third part of the fifth, in the pharmaceutical industry has had great benefits but, eCTD to make itself one is a challenge. This eCTD generation, may be commissioned to conduct our own in-house and external.Each merit, but disadvantages in this course is to explain the process to approval based on preliminary considerations apply to the benefits of outsourcing and external contractors mostly.The commentary will also consider other matters that require minimal in-house.
1. ECTD and
1. ECTD History
2. ECTD Configuration
3. ECTD creating
4. ECTD Regulatory Considerations in the Application
2. ECTD creation and outsourcing of its own
1. ECTD to prepare for the introduction
2. To create its own advantages and disadvantages of outsourcing
1. Pros and Cons of approval
2. Advantages and Disadvantages of non-approval
3. Factor in deciding their own creation and outsourcing
4. Considerations when outsourcing
5. Considerations when outsourcing
3. ECTD preparation for the application
1. Materials (documents) prepared in the preparation
2. Materials (documents) prepared in the management
3. ER / ES to support
4. Support in the organizational structure
5. Other Considerations
* Exchange business cards Q & A
Lecturer
Janssen (Ltd.) Director of Regulatory Affairs Division,Subcommittee head computerized information for Drug Evaluation Committee before the Japan Pharmaceutical Manufacturers AssociationJapan Pharmaceutical Manufacturers Association before the project board ICH Topic M2 ReaderPublic Wear NPO Organization (MIST) CouncilMr. Adati TakeshiCareer
Pharmacist, MBA.After graduating from the Faculty of Pharmaceutical Sciences, Kanazawa University, he joined the pharmaceutical industry investment in the laboratory, a researcher engaged in analytical chemistry.In addition to research activities during this analysis LIMS (Laboratory Information Management System) also deals with construction.Then transferred to pharmaceutical business development, including foreign pharmaceutical companies undertake the review of new drug approval for about 15 years.Also, during this period, safety and operations also experienced post-marketing surveillance.Industry activities, the former Committee on ESMI Japan Pharmaceutical Manufacturers Association (now Electronic Information Division) engaged in various activities in the eCTD for the introduction of a national.The NPO also wear Organization who is also a public director.Isao Makoto on the subject, etc.
* ECTD Japanese Local Guidance: 5th Annual Workshop in Japan for Medical Information Processing DIA, 2004
Intermediate study of electronic standards * Japan Pharmaceutical Manufacturers Association, Information Management Division the opportunity to co-University Hospital in Takamatsu, 2008
* Current standards for electronic document management in clinical trials, 3rd MIST Symposium, 2008
* Current state of electrons in the pharmaceutical industry 4th MIST Symposium, 2008
* Direction of Computerization in Pharmaceutical Development; The 6th Annual Japan DIA Meeting 2009
Electronic and other drug development, eCTD many lectures on the relationshipSpecial discounts for several people simultaneously take
* Per person if two people participated in 7,350 yen discount
* Per person discount when participating in three 10,500 yen (limited to the same corporation)
VenueShinko KaikanShibakouen 3-5-8, Minato-ku
Floor Room No. 6 6D-3Sponsored byScience & Technology Co., Ltd.Payment, whether or not to cancel, thank you to always check before you apply.Contact UsInquiries about this seminar, thank you from the tech-seminar.jp inquiry.(Contact us directly to the organizer Please refrain.)Fees (tax included)Solo: 42,000 yenSeveral people: 34,650 yenSign up for seminarsPresentation order program are subject to change. Please note.
* CTD (Common Technical Document)
* Drugs
Relevant seminars / relevant publicationsMotomu Kaname differences based on very efficient 3 CMC expertise to create the required application materials and information containedPharmacokinetics ("F" section) and ensure data in the study to ensure reliability of test methods QC · QA / TimingNDA dossier for creating data / assurance and testing to ensure reliability check method QC · QA / TimingPharmacology study ("E" section) to ensure reliability and assurance in check method QC · QA / TimingQuality ("b", "C" section) to ensure high reliability of the test method QC · QA check / TimingBased on drug GMP ~ 3-pole responseTrial QC / QA ~ GCP Taking into account the assessment of suitability issues identified -DMF and thorough comparison of the three regions of CTD M3 shown how to reflect the relevance of preparationCTD clinical study report on the minimum you need to know to create knowledge and statisticsAntibody (bio) pharmaceutical expertise CMC / review the application and the matters inquired into the actual response
For More information in Japanese Language Please Click : Japan eCTD
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