Fxtrans:Best Practices for translating Japanese regulatory submissions

Many medical device companies doing business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that U.S.-based companies often do not know exactly what was submitted to the government, which can have serious implications.

For more Information please click:Fxtrans Japanese Regulatory Submissions

EXTEDO:The latest from the FDA: “Preparing for the New Module 1and Validation Criteria - Webinar

In this webinar attendees will learn what they need to do in order to prepare for the new Module 1 and Validation Criteria updates being issued by the FDA. The eCTD Validation Criteria includes additions and deletions of error codes. The Module 1 updates are based on a history of eCTD submissions dating back to 2003.

Join us on May 12, 2011 as we discuss the following topics:

The benefits of going electronic.
How to check if your eCTD submission is valid
Review of new and removed error codes
Review of Module 1 changes
Overview of new file formats and media types
Grouped submissions
Tips to prepare for the upcoming changes

For more information Please Click: EXTEDO eCTD Webinar

Analyst Report: Recent Uptick in NDA/BLA Refuse-to-File Letters Signals Changes at FDA

Analyst Report Suggests Recent Uptick in NDA/BLA Refuse-to-File Letters Signals Changes at FDA - By Kurt R. Karst

A recent report from Leerink Swann LLC analyst Howard Liang, Ph.D. suggests that what appears to be a recent increase in the number of Refuse-to-File (“RTF”) letters issued by FDA to NDA and BLA sponsors – some of which are large, experienced biotech companies – might signal both a greater willingness from FDA to issue such decisions, and therefore a higher filing threshold, and that filing decisions are no longer non-events.

For more Information please click: FDA LAW Blog- Analyst Report

eCTDconsultancy: Principles of the new EU Variation Regulation - SlideShare by Hans Van Bruggen

eCTDconsultancy: Principles of the new EU Variation Regulation - SlideShare by Hans Van Bruggen.

For More Information Please Click: SlideShare eCTD

eCTDconsultancy: How to handle Grouping and Worksharing in EU eCTD Submissions - SlideShare by Hans Van Bruggen

eCTDconsultancy: How to handle Grouping and Worksharing in EU eCTD Submissions - SlideShare by Hans Van Bruggen


Fore More Information Please Click: SlideShare eCTD

Exalon:EU Additional data Requirements for new applications in MRP/DCP

The Co-ordination Group for Mutual Recognition and Decentralized Procedure - Human (CMD(h)) has released an updated version (Rev 6, April 2011) of the table listing additional data that is requested by EU Member States for new application in the MRP or DCP. Data listed concerns documents and information that is not stated in the current EU legislation, Volume 2B and/or in the EEA approved Guidelines / Recommendations.

For More Information please click: Exalon EU Addtional Data Requirements for MRP/DCP

eCTD Tips: Making Text “Hyperlink Blue” in Word 2010

Making Text “Hyperlink Blue” in Word 2010

My company recently upgraded from Microsoft Office 2003 to Microsoft Office 2010. Overall, the upgrade has been great, but we have encountered a couple of issues that have impacted our eCTD submissions.

One minor, but annoying, issue is that the color we’ve all come to know as “hyperlink blue” is no longer one of the default option in the font color picker. We ask our authors to identify the text to create all internal hyperlinks as they go, and to identify text to be externally hyperlinked by turning it “hyperlink blue.” Since “hyperlink blue” is no longer a default option for them to select, I’ve been receiving documents with varying shades of blue, depending on which of the default options they chose. This isn’t a problem that could cause a submission to be rejected, but it is a concern for those of us who want to ensure that the FDA reviewers are presented with a consistent look for every document in a submission.

Fore More Information please click: eCTD Tips:Making Text “Hyperlink Blue” in Word 2010

The eCTD Summit: EDMS/Publishing Integration: The Optimal Approach

EDMS/Publishing Integration: The Optimal Approach

This entry was written by Kathie Clark, former Director of Professional Services at GlobalSubmit.

Most Tier I and Tier II sponsors maintain their submission documents in an electronic document management system (EDMS). It’s obvious that software that creates electronic (or paper) submissions must work with the documents managed in the EDMS. But what is not so obvious is the optimal integration between an EDMS and a publishing tool.

For More Information Please click: The eCTD Summit EDMS

CDISC:Amendment 1 to the Study Data Tabulation Model (SDTM) v1.2 and the SDTM Implementation Guide: Human Clinical Trials V3.1.2 Open for Public Review

Amendment 1 to the Study Data Tabulation Model (SDTM) v1.2 and the SDTM Implementation Guide: Human Clinical Trials V3.1.2 Open for Public Review

The Submissions Data Standards Team is pleased to release this amendment for public review.

This document includes additional variables related to human clinical trials added at the request of FDA CDER and is being posted for comment and for trial use in advance of the next formal release of the SDTM and SDTMIG. Please provide review comments using the spreadsheet provided below by 26 May 2011.

For more information please click: CDISC SDTM

Exalon: EMA releases updated distribution requirements and address list for PSURs

An updated list of addresses and distribution requirements for Periodic Safety Update Reports (PSURs) has been released today by the European Medicines Agency.

Fore more information click: Exalon:EMA PSUR Update

"ICH at 20" ICH's Focus on main achievements over the last 20 years, especially CTD/eCTD

DIA Global Forum Article - "ICH at 20" focus ICH's main achievements over the last 20 years, especially CTD/eCTD.

Fore more Information please click : ICH eCTD

RAPS: Advanced eCTD Submissions (A Interactive workshop)

RAPS: Advanced eCTD Submissions (A Interactive workshop)

Hyatt Regency Long Beach
Long Beach, CA
20–22 July 2011

For more information please click RAPS eCTD

New CDER Data Standards Program web page on the FDA site

New CDER Data Standards Program web page on the FDA site

For more information please click: FDA CDER Data Standards

Preparing for the New Global Requirements for eCTD and Regulated Product Submissions Mastering the Tools and Strategies

Preparing for the New Global Requirements for eCTD and Regulated Product Submissions
Mastering the Tools and Strategies

Tuesday, May 24 - Wednesday, May 25, 2011

Radisson Hotel Boston
200 Stuart St.
Boston, MA 02116
Toll Free: (800) 395-7046
+1 (617) 482-1800
www.radisson.com/bostonma
Room rate: $190.00 plus 14.45 percent tax
Reservation cut-off date: May 3, 2011

For More Information please click: eCTD Workshop

eCTD Tips: Metadata for a Drug Product that is Referenced but not Included?

Recently, I’ve been working on an eCTD IND that includes three drug products, A, B, and C. Drug product A is the sponsor’s own product, and so we included the appropriate metadata for this product along with the necessary documents in Module 3.2.P. However, drug products B and C are proprietary products of other manufacturers. These two drug products are incorporated into the IND via the right of reference to their respective DMFs.

For More Information please click : eCTD Tips Metadata

GlobalSubmit: The Most Common Study Tagging File Error Question

when working with the Study Tagging Files XML which is a very common area of confusion for most people new to eCTD and XML in general. I have spent a lot of time creating the XML for sequences by hand, and have examined sponsors’ XML to determine the location of the error. Because of these experiences, I thought it would be beneficial to discuss the basic structure of the index.xml, stf.xml, and the single most common question I receive related to the STF which is, “Why am I seeing errors 1952, 1953 and are these the same error?”

For more information please click GlobalSubmit: The Most Common Study Tagging File Error Question

Global Submit: Free White Paper - Understanding High Severity Level eCTD Errors

It may often seem like there are more questions than answers, such as “What is a high severity level error?” and “How can I correct it?” GlobalSubmit address these questions and more in our FREE white paper: Ensuring eCTD Quality: Specifications for eCTD Validation Criteria.

For More Information Please click the weblink Global Submit: Free White Paper

ExL Pharma: Regulatory Information Management Conference

ExL Pharma: Regulatory Information Management Conference

For more information please click ExL Pharma Conference

nextdocs: Regulatory Document Management with Microsoft SharePoint 2010 Webinar

Nextdocs: Regulatory Document Management with Microsoft SharePoint 2010 Webinar

Fore more Information Please click Webinar

Training Course for eCTD Submissions in Switzerland

Since January 2010, Swissmedic accepts electronic-only submissions in eCTD-format. This course will
offer insight into the compilation of the eCTD, share experience and best practice gained during eCTD
submissions in Switzerland, and the eCTD review process. The focus will be on practical experience
gained in preparing and submitting eCTDs to Swissmedic.

Location:
Hotel Ambassador & Spa
Seftigenstrasse 99
3007 Bern
Switzerland

Date(s) And Time(s):
Jun 16 2011 8:00AM - Jun 16 2011 5:30PM

For More Information Please Click: eCTD Training

Considerations in application outsourcing and use of eCTD: Conference in Japan April 18, 2011

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

FIMEA Announced No Need of Paper copies for electronic submissions

The Finnish Medicines Agency Fimea announced today that the Agency started to accept electronic submissions for new applications as well as variations and renewals without requesting further printed copies on 1st April, 2011.

For More Information please click FIMEA e-Submissions

Training Course on Building the eCTD - Practical Solutions to Compile Electronic Submissions in France

Training Course on Building the eCTD - Practical Solutions to Compile Electronic Submissions in France

For More Information Please click DIA:eCTD in France

EMA: Status Summary of EURS - April 2011

The EMA is using since November 2010 EiY release 2.8.1.52 HF6 from Extedo in production. This version of EURS has proved to be stable and no major problems have been reported since last November.

For More Information Please click  EMA:EURS

CDISC SDTM Draft Oncology Domains Open for Public Review

The Oncology Sub Team of the CDISC Submission Data Standards (SDS) Team is pleased to release three new SDTM-based domains for public review. The domains have been created with input from FDA, NCI, sponsor companies, CROs, and imaging specialists.

For More Information Please Click CDISC SDTM 

Kind Regards

Shakul.