Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Abbreviated New Drug Application (ANDA) Submission:
Introduction
Basic Generic Drug Requirements
Goals of ANDA
Basis of ANDA Submission
ANDA Forms and Submission Requirements
ANDA Review Process
CTD Triangle
Electronic Submissions
Checklist for ANDA submission (Module 1 to Module 5)
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
Abbreviated New Drug Application (ANDA) Submission:
Introduction
Basic Generic Drug Requirements
Goals of ANDA
Basis of ANDA Submission
ANDA Forms and Submission Requirements
ANDA Review Process
CTD Triangle
Electronic Submissions
Checklist for ANDA submission (Module 1 to Module 5)
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
USUGM 2014 - Jinling Sui (Flately Discovery): Building the Bioinformatic Pla...ChemAxon
Building a suitable bioinformatic platform for small molecule R&D with high throughput screening (HTS) is challenging for a small biotech startup with limited experiences and resource. At Flatley Discovery Lab, we started with desktop-based data process and library management applications in our initial chemical library build-up and HTS data processing. We have grown into an Oracle-based system, and implemented additional commercial packages on the platform. The system is designed and tailored to meet exactly the need of our biologists and chemists. With desktop-based component remains to be the front end for HTS raw data processing and data QC, advanced data analysis and visualization tools are introduced to support our SAR and lead development efforts. In only a few years since its inception, Flatley Discovery Lab has discovered several exciting CFTR modulators in the development pipeline toward a new and efficacious treatment for Cystic Fibrosis.
Lifesciences IT - 2011 YearbookSummaryGBI Research's research, 'Lifesciences IT - 2011 Yearbook" provides key data, information and analysis on Lifesciences \IT that is being implemented by pharmaceutical companies. GBI Research expects that information technology (IT) in the lifesciences industry will become a trendsetter, helping pharmaceutical companies mitigate current and evolving industry challenges. IT solutions utilized in the value chain of pharmaceutical companies help them to operate effectively and efficiently. GBI expects an increase in the adoption of IT by pharmaceutical companies looking to remain competitive in the market place. The Lifesciences industry is pressurized by various challenges such as declining Return on Investment (ROI) on R&D investments, entry of generics and layoffs. These factors are responsible for the lifesciences companies to invest in information technology solutions. Pharmaceutical companies have found that experimental techniques are costly, time-consuming, and involve the use of large numbers of animals for testing and are adapting to computerized combinatorial chemistry applications. Pharmaceutical Companies are increasingly adopting e-clinical trial solutions in the drug development phase. Cutting down clinical trial cost is the driving motivation for the adoption of e-clinical trial solutions. Services offered by IT companies in clinical data management are costly but have been proved to save cost for the companies in the long run. CTMS and EDC will attract the highest investments in the future followed by data mining, electronic submission tools and RFID. Outsourcing helps a pharmaceutical company to reduce costs by 30-35% and this is one of the main reasons why pharmaceutical companies outsource non-core R&D operational work to IT companies. When selecting a country to outsource clinical data management work, building the required competencies to tackle client requirements has gained a higher importance than the cost advantage it provides. The predictive analytics helps a company view beyond the sales volume in to real time prescribing patterns, as a behavior of continuum. This also helps the company to follow the evolving niche buster model. Many pharmaceutical companies have increased satisfaction levels from their customers in 2008. In 2004, 50% of the physicians were satisfied on the current number of calls. However, satisfaction levels have increased in 2008 with more than 57% of the physicians in the US satisfied with the current number of calls. The increase in satisfaction levels was directly proportional to the decrease of sales force in the US. It is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research's team of industry experts.ScopeThe scope of this report includes - - Analysis of the leading segments in the Lifesciences IT market - Key drivers and barriers that have a significant impact on the Lifesciences IT market. - Competitive benchmarking of leading companies in the market. - Key M&A activities and strategic partnership deals that have taken place in 2009.- Inputs for customized IT solution based on business situation.Reasons to buyThe report will enhance your decision making capability. It will provide you with - - Align your product portfolio to the markets with high growth potential.- Develop market-entry and market expansion strategies by identifying the leading segments poised for strong growth.- Device better strategies through the understanding of key drivers and barriers in the market.- Develop key strategic initiatives by understanding the key focus of leading companies.- Accelerate and strengthen your market position by identifying key companies for mergers, acquisitions and strategic partnerships.
Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...April Bright
Scientific data, homegrown or from published literature, is essential to your regulatory strategy…be it establishing substantial equivalence in FDA 510(k) applications, qualifying a device as a legitimate predecessor in the context of a Technical File for CE Mark, predicting the performance of a device in development, judging a new device in verification and validation testing and, with proper planning, expanding indications for use and identifying new marketable claims of performance (or mitigation of risk and liability). In this session, participants will be exposed to various vital data sources and obtain practical examples for putting them to meaningful use.
Pistoia Alliance SESL pilot Bio IT World Hanover 12 Oct 2011Ian Harrow
Towards a brokering framework for knowledge-based services: learning from the Pistoia Alliance SESL pilot
Ian Harrow PhD for the Pistoia Alliance
This presentation describes a pilot project to determine the feasibility of biomedical knowledge brokering. It shows query across multiple disparate data sources through a brokering demonstrator built from RDF triple store technology. The learning from this pilot is contributing to larger scale projects such as the Innovative Medicines Initiative, OpenPFACTs.
Towards a brokering framework for knowledge-based services: Learning from the...Pistoia Alliance
Ian Harrow, co-leader of the Pistoia Alliance SESL pilot, describes the vision for the SESL pilot, the outcomes, and the project's future. The presentation at the 2011 BioITWorld Conference and Expo included a link to the SESL public demonstrator.
Digital Stories: The Voice that Motivates ActionMike Paciello
At root, the reason why information and communication technologies are not accessible to people with disabilities is simply this: We need to better understand users by empathically listening to their stories and designing to their needs.
The specialized industry of collecting electronic patient-reported outcomes is increasing linearly, in part because global government regulators want to hear directly from the patient, and because the acceleration and availability of electronic collection (vs. paper collection) improves data quality and efficiencies for data analysis and trial management. This document will review the ePRO market, and outline the five ePRO methods what successfully support the collection of patient-reported data
Safe Nests in Global Nets - Innovation and IPAlberto Minin
This presentation and related paper contributes to research providing a new interpretation for the appropriability of critical industrial R&D, and in general to the literature on internationalization and maturation of R&D off shoring.
Critical R&D projects and technologies remain home-bound even in very large multinationals. Why? I was able to discuss the result of my quantitative empirical analysis directly with the managers involved in key decisions relating to the development of some of these technologies.
Their viewpoint suggests the presence of what I have defined “Safe R&D nests”. I will discuss that such “safeness” derives by a close coordination between scientific and technological research and management of intangible assets.
DataCyte - The Future of Data Storage & RetrievalDaniel Opland
The vision for the creation of DataCyte was to create a data storage and retrieval structure which would enable the development of applications in an organic manner and where the performance of the applications would be largely independent of the amount of data and the relationships built between the data elements.
The Cognitive Era and the Future of ContentScott Abel
A new era of computing—The Cognitive Era—is taking shape right now. It promises monumental change; altering forever the way we create, manage, and deliver content.
Over the next two decades cognitive computing will radically transform every aspect of our field. It will change the way human beings around the globe live and work. It will change the way business solve problems and make decisions. And, it will provide us with powerful methods of enabling customer success.
The Cognitive Era is not science fiction. It’s science fact. It’s here today. Let’s explore the possibilities.
The cognitive era and the future of contentScott Abel
A new era of computing—The Cognitive Era—is taking shape right now. It promises monumental change—altering forever the way we create, manage, and deliver content. Over the next two decades cognitive computing will radically transform every aspect of our field. It will change the way human beings around the globe live and work. It will change the way business solve problems and make decisions. And, it will provide us with powerful methods of enabling customer success.
The Cognitive Era is not science fiction. It’s science fact, and it’s here today.
Establishing thought leadership with content manufacturing and influencer mar...Scott Abel
One of the biggest problems facing content marketers and other content professionals today is their inability to create content that establishes a brand as a thought leader. There's never enough time to create all the content needed. This presentation examines an influencer marketing campaign that takes advantage of content manufacturing and that leverages the unified content strategy. While you may not leverage the same tools and standards that we did, the concepts are applicable to almost any content producing organization.
Creating A Digital Content Factory: Getting Started with Intelligent ContentScott Abel
Content marketing production processes are broken. Most organizations can’t crank out the wide variety of content needed because their processes are outdated, inefficient, and riddled with waste. Oh, and then there are tools. Content marketers don’t have the right ones for the jobs at hand.
In this presentation, content strategy guru Scott Abel, The Content Wrangler, will demystify the benefits of intelligent content for content marketers and outline the changes needed in order for marketers to take advantage of the approach.
Attendee takeaways:
How adopting intelligent content can turn a content marketing department into a content marketing factory
How some brands are leveraging intelligent content to produce more content with less effort
Lessons learned from the pros working in the trenches
What you’ll need to get started
#CMWorld
Intelligent Content in the Experience Age by Scott Abel, The Content WranglerScott Abel
In the Experience Age, consumers expect much more from brands than they have in the past. Once they’ve enjoyed an exceptional customer experience, they become intolerant of confusing, irrelevant, and inconsistent content. Brands that recognize this fact and deliver exceptional content experiences across all customer touchpoint will be rewarded with loyalty.
In order to deliver exceptional content experiences, savvy brands are taking a critical look at how they create, manage, and deliver content. And, what they’re finding is that the approaches they’ve relied on for decades can no longer meet current and future business needs.
Enter intelligent content. Content with superpowers. Content that is designed to dynamically adapt to meet customer needs. It’s content that is digital, data-driven, and dynamic. It’s digital in that it is designed and built for a connected world. It is data-driven in that can be connected to — and integrated with — enterprise data resources. And, it’s dynamic in that it can automatically respond to individual customer needs.
During this opening keynote presentation (originally delivered at the Intelligent Content Conference in San Francisco, March 2015), Scott Abel, The Content Wrangler, and co-founder of the Intelligent Content Conference will explore the need for intelligent content in the Experience Age. You’ll discover why our current processes are insufficient, and what some companies are doing to overcome traditional publishing roadblocks.
Emerging Trends in Visual Content Marketing with Adam HelwehScott Abel
Did you know that the average human brain processes information that is more visual up to 60,000 times faster than text? But wait! Text is visual right? Not in the same way. Photos, videos and other visual mediums communicate on a whole 'nother level than a paragraph of text. The rise of visual content marketing over the last couple of years has been driven by bevy of platforms and tools that give little excuse to not include it into your marketing efforts.
Join Adam Helweh as he identifies these trends, explores the tools and helps you create a more vibrant visual marketing mix for your audience.
You will learn:
• Why is visual content more effective than other types of content
• What emerging trends and tools are driving the use of visual content
• How to go beyond the confines of the static image to make visual content that’s more alive and engaging.
This presentation was given at Content Strategy Applied USA on November 17-18, 2014
Scalable Content Strategy: Nice Thought or Viable Vision? with Colleen JonesScott Abel
Today, business is digital. That makes content critical. Content now represents nearly a third of marketing budgets alone (Content Marketing Institute), and that proportion will only increase. Content also is the substance of most digital media products and digital channel communications. So, you might have enjoyed some success with implementing a content strategy for a single product, channel, or marketing campaign. Now, imagine repeating that success. How do you make your content strategy scale across products, brands, channels, markets and more? It's a question that often brings up many, many, MANY more questions for midsize and enterprise organizations. This session will help you answer them with a practical vision and 3 useful principles to scale your content strategy.
This presentation was given at Content Strategy Applied USA on November 17-18, 2014
Content Strategy Across Geographies and Platforms with Melinda FloresScott Abel
When creating websites and apps for a multinational organization like IBM or GE, how do you ensure that global content is easily adaptable and translatable? Especially when you're creating content that needs to be accessed via tablet, phone and desktop? This presentation covers the basics of creating global content strategy for audiences with varying needs based on geography and language.
This presentation was given at Content Strategy Applied USA on November 17-18, 2014
The ROI of Intelligent Content with Mark Lewis, DITA Educator, QuarkScott Abel
You CAN prove the savings possible from moving your unstructured content to intelligent content. The benefits are measurable. Intelligent content combined with a content management system can facilitate savings and improvements in content development, translation, regulations, governance, multi-channel publishing, and quality.
In this session, Mark discusses how the various processes benefit from intelligent content and discusses metrics that prove the benefit. If it hurts, then it's time to calculate the pain — and the relief. This session draws from concepts in Mark's book, DITA Metrics 101, The Business Case for XML and Intelligent Content.
Mark also discusses which metrics you should gather so you can align your plan with corporate strategy and become the "Executive Whisperer."
This session is part of The Content Wrangler Virtual Summit on Advanced Technical Communication Practices, December 4-5, 2014. Hosted by BrightTALK. Sponsored by SDL, Astoria Software, Acrolinx, oXygen XML Editor, Logos, Scriptorium, and Oberon Technologies.
Content Strategy for Technical Communication and Beyond with Gretyl Kinsey, S...Scott Abel
Content strategy is about so much more than streamlining your content development process—it's about supporting your organization's business goals. To be truly effective, your content strategy should be global. That means breaking down the barriers that keep the different types of content producers in your organization apart.
Your organization creates various kinds of content—technical, marketing, training, and more. Your content strategy may begin with tech comm, but it should also account for these other types of content to present a unified message and better serve your brand. This presentation shows how, with a global strategy, all of your content can work together to help your organization succeed.
Gretyl Kinsey is a technical consultant with Scriptorium Publishing who specializes in content strategy and tech comm tools and technologies. Since joining Scriptorium in 2011, she has been involved with the development and implementation of content strategies for organizations in a variety of industries. She has experience with every step of the implementation process, from customizing transforms to converting legacy content to helping with follow-on support. She also frequently contributes her graphic design skills to the marketing side of Scriptorium. With a background in journalism and visual communication, she is interested in the convergence between technical and marketing communication, and in content strategies that encourage it.
This session is part of The Content Wrangler Virtual Summit on Advanced Technical Communication Practices, December 4-5, 2014. Hosted by BrightTALK. Sponsored by SDL, Astoria Software, Acrolinx, oXygen XML Editor, Logos, Scriptorium, and Oberon Technologies.
The Future of Technical Communication is Marketing with Scott Abel, The Conte...Scott Abel
Once a prospect buys a product or service, the content they interact with is no longer familiar. The instructions provided don't look, feel, or sound anything like the marketing and sales materials that introduced them to your brand. Neither does the service contract, the warranty, the customer support website, the product documentation, nor the training materials.
The extensive variability in customer experience — and each customer touchpoint — creates a different and inconsistent version of the brand, some that bear little or no resemblance to the brand that executives believe they are building. There are often as many brands as there are touch points.
For no good reason, the content experience changes drastically -- and not in a good way. That's why organizations that recognize the importance of a unified customer experience have started rethinking what it means to be customer-centric.
Some forward-thinking organizations are reorganizing customer-facing content creators into teams under one roof. They're breaking down the barriers — the silos — that prevent them from collaborating; from creating a unified customer content experience.
In this presentation, Scott Abel, The Content Wrangler, discusses the challenges of content inconsistency and incongruity, and why he thinks the future of technical communication is marketing.
This session is part of The Content Wrangler Virtual Summit on Advanced Technical Communication Practices, December 4-5, 2014. Hosted by BrightTALK. Sponsored by SDL, Astoria Software, Acrolinx, oXygen XML Editor, Logos, Scriptorium, and Oberon Technologies.
Clear and Simple: Lower Your Content Costs with Global English with Matthew K...Scott Abel
In this webinar, Matt and Greg explain what Global English is and who it benefits, introduce you to some Global English techniques that you can implement immediately, and they examine a couple of case studies of companies who have implemented Global English—and have experienced dramatic results.
This session is part of The Content Wrangler Virtual Summit on Advanced Technical Communication Practices, December 4-5, 2014. Hosted by BrightTALK. Sponsored by SDL, Astoria Software, Acrolinx, oXygen XML Editor, Logos, Scriptorium, and Oberon Technologies.
Fandom Isn't Random with Andrew Thomas, SDLScott Abel
Andrew Thomas shows you a fast-paced look at how to leverage content to cultivate a loyal customer base.
Andrew Thomas is a Director of Product Marketing for Content Management Technologies at SDL, focusing on structured content technologies. Andrew has worked with XML for a wide variety of content, from marketing materials, to printed manuals and web applications. He's witnessed firsthand, the diversity of structured content and how it can empower businesses and customer engagement. Before joining SDL, Andrew was a language intelligence solutions manager for Adobe Systems and oversaw the translation process for their DITA content.
This session was part of The Content Wrangler Virtual Summit on Advanced Technical Communication Practices, December 4-5, 2014. Hosted by BrightTALK. Sponsored by SDL, Astoria Software, Acrolinx, oXygen XML Editor, Logos, Scriptorium, and Oberon Technologies.
Deep Dive: Structured XML Authoring with George Bina, oXygen XML EditorScott Abel
George Bina explores the world of XML authoring for technical documentation. He shares tips and tricks designed to help technical communicators understand the advanced information management capabilities structured XML authoring provides over traditional authoring approaches.
Specifically, George addresses the following questions:
How do I know what content to create?
What XML markup should I choose and why?
How do I leverage markup to engineer better authoring experiences?
How to we enforce content rules in XML documents?
Why correcting content problems during the authoring process can help you reduce costs?
This session was part of The Content Wrangler Virtual Summit on Advanced Technical Communication Practices, December 4-5, 2014. Hosted by BrightTALK. Sponsored by SDL, Astoria Software, Acrolinx, oXygen XML Editor, Logos, Scriptorium, and Oberon Technologies.
The Future of Technical Communication is MarketingScott Abel
Once a prospect buys a product or service, the content they interact with is no longer familiar. The instructions provided don't look, feel, or sound anything like the marketing and sales materials that introduced them to your brand. Neither does the service contract, the warranty, the customer support website, the product documentation, nor the training materials.
The extensive variability in customer experience — and each customer touchpoint — creates a different and inconsistent version of the brand, some that bear little or no resemblance to the brand that executives believe they are building. There are often as many brands as there are touchpoints.
For no good reason, the content experience changes drastically -- and not in a good way. That's why organizations that recognize the importance of a unified customer experience have started rethinking what it means to be customer-centric.
Some forward-thinking organizations are reorganizing customer-facing content creators into teams under one roof. They're breaking down the barriers — the silos — that prevent them from collaborating; from creating a unified customer content experience.
In this presentation, delivered at Acrolinx Day at LavaCon 2014 Portland, Scott Abel, The Content Wrangler, discussed the challenges of content inconsistency and incongruity, and why he thinks the future of technical communication is marketing.
The Making of 'The Language of Content Strategy' - by Scott Abel, The Content...Scott Abel
Time is in short supply. Deadlines are tight. Resources are even tighter. If you're like most content professionals, you have dozens of great ideas but not enough time, money or experience to bring them to life. But it doesn't have to be this way.
In this content marketing meets intelligent content engineering case study, we will explain how the newly published book, The Language of Content Strategy (XML Press) was created with the help of the crowd, structured XML content, a wiki and a formal content strategy. Attend this session to learn how the two seasoned content strategists enlisted the help of 50 knowledgeable experts to create a printed book, an e-book, a companion website and educational flash cards in record time, all from a single source of content. You'll discover why it's imperative that content professionals —regardless of their area of specialty — understand and leverage the power of advanced information development practices. You'll leave knowing why a repeatable content production system, optimized for productivity and designed to efficiently produce multiple content products simultaneously, is no longer an option, but rather a necessity.
5 Revolutionary Technologies Technical Communicators Can’t Afford To IgnoreScott Abel
Getting the right information to the right people, at the right time, in the right format, and in the right language is the goal of every professional technical communicator. But, the pace of change is fast, and each and every step forward is often accompanied by two steps back. That’s because the speed of technological change is outstripping our ability to keep up. It seems we’re always playing catch up. But, it doesn’t have to be that way.
In this slide deck, Scott Abel, The Content Wrangler, showcases five powerful information technology innovations that, when harnessed by professional technical communicators, can help us future-proof our content and ensure we’re meeting – even exceeding – our goals.
Content Marketing Futurist: Revolutionary Technologies Content Marketers Can’...Scott Abel
Getting the right information to the right people, at the right time, in the right format, and in the right language is the goal of every professional content marketer. But, the pace of change is fast, and each and every step forward is often accompanied by two steps back. That’s because the speed of technological change is outstripping our ability to keep up. It seems we’re always playing catch up. But, it doesn’t have to be that way.
In this Content Marketing World 2014 presentation, Scott Abel, The Content Wrangler, showcases five powerful information technology innovations that, when harnessed by professional content marketers, can help us future-proof our content marketing efforts and ensure we’re meeting – even exceeding – our goals.
Thinking Strategically About Content - Localization World SingaporeScott Abel
In this presentation from Localization World Singapore, April 2013, Scott Abel explores the importance of thinking strategically about content (how it is created, why its created, and the goals of global content initiatives) by helping the audience understand the importance of vision in content strategy. The presentation also touches on how organizations can find time for innovation and provides several resources for content strategy professionals.
Even tho Pi network is not listed on any exchange yet.
Buying/Selling or investing in pi network coins is highly possible through the help of vendors. You can buy from vendors[ buy directly from the pi network miners and resell it]. I will leave the telegram contact of my personal vendor.
@Pi_vendor_247
The Evolution of Non-Banking Financial Companies (NBFCs) in India: Challenges...beulahfernandes8
Role in Financial System
NBFCs are critical in bridging the financial inclusion gap.
They provide specialized financial services that cater to segments often neglected by traditional banks.
Economic Impact
NBFCs contribute significantly to India's GDP.
They support sectors like micro, small, and medium enterprises (MSMEs), housing finance, and personal loans.
how can I sell pi coins after successfully completing KYCDOT TECH
Pi coins is not launched yet in any exchange 💱 this means it's not swappable, the current pi displaying on coin market cap is the iou version of pi. And you can learn all about that on my previous post.
RIGHT NOW THE ONLY WAY you can sell pi coins is through verified pi merchants. A pi merchant is someone who buys pi coins and resell them to exchanges and crypto whales. Looking forward to hold massive quantities of pi coins before the mainnet launch.
This is because pi network is not doing any pre-sale or ico offerings, the only way to get my coins is from buying from miners. So a merchant facilitates the transactions between the miners and these exchanges holding pi.
I and my friends has sold more than 6000 pi coins successfully with this method. I will be happy to share the contact of my personal pi merchant. The one i trade with, if you have your own merchant you can trade with them. For those who are new.
Message: @Pi_vendor_247 on telegram.
I wouldn't advise you selling all percentage of the pi coins. Leave at least a before so its a win win during open mainnet. Have a nice day pioneers ♥️
#kyc #mainnet #picoins #pi #sellpi #piwallet
#pinetwork
how to swap pi coins to foreign currency withdrawable.DOT TECH
As of my last update, Pi is still in the testing phase and is not tradable on any exchanges.
However, Pi Network has announced plans to launch its Testnet and Mainnet in the future, which may include listing Pi on exchanges.
The current method for selling pi coins involves exchanging them with a pi vendor who purchases pi coins for investment reasons.
If you want to sell your pi coins, reach out to a pi vendor and sell them to anyone looking to sell pi coins from any country around the globe.
Below is the contact information for my personal pi vendor.
Telegram: @Pi_vendor_247
how to sell pi coins on Bitmart crypto exchangeDOT TECH
Yes. Pi network coins can be exchanged but not on bitmart exchange. Because pi network is still in the enclosed mainnet. The only way pioneers are able to trade pi coins is by reselling the pi coins to pi verified merchants.
A verified merchant is someone who buys pi network coins and resell it to exchanges looking forward to hold till mainnet launch.
I will leave the telegram contact of my personal pi merchant to trade with.
@Pi_vendor_247
where can I find a legit pi merchant onlineDOT TECH
Yes. This is very easy what you need is a recommendation from someone who has successfully traded pi coins before with a merchant.
Who is a pi merchant?
A pi merchant is someone who buys pi network coins and resell them to Investors looking forward to hold thousands of pi coins before the open mainnet.
I will leave the telegram contact of my personal pi merchant to trade with
@Pi_vendor_247
Currently pi network is not tradable on binance or any other exchange because we are still in the enclosed mainnet.
Right now the only way to sell pi coins is by trading with a verified merchant.
What is a pi merchant?
A pi merchant is someone verified by pi network team and allowed to barter pi coins for goods and services.
Since pi network is not doing any pre-sale The only way exchanges like binance/huobi or crypto whales can get pi is by buying from miners. And a merchant stands in between the exchanges and the miners.
I will leave the telegram contact of my personal pi merchant. I and my friends has traded more than 6000pi coins successfully
Tele-gram
@Pi_vendor_247
Introduction to Indian Financial System ()Avanish Goel
The financial system of a country is an important tool for economic development of the country, as it helps in creation of wealth by linking savings with investments.
It facilitates the flow of funds form the households (savers) to business firms (investors) to aid in wealth creation and development of both the parties
Financial Assets: Debit vs Equity Securities.pptxWrito-Finance
financial assets represent claim for future benefit or cash. Financial assets are formed by establishing contracts between participants. These financial assets are used for collection of huge amounts of money for business purposes.
Two major Types: Debt Securities and Equity Securities.
Debt Securities are Also known as fixed-income securities or instruments. The type of assets is formed by establishing contracts between investor and issuer of the asset.
• The first type of Debit securities is BONDS. Bonds are issued by corporations and government (both local and national government).
• The second important type of Debit security is NOTES. Apart from similarities associated with notes and bonds, notes have shorter term maturity.
• The 3rd important type of Debit security is TRESURY BILLS. These securities have short-term ranging from three months, six months, and one year. Issuer of such securities are governments.
• Above discussed debit securities are mostly issued by governments and corporations. CERTIFICATE OF DEPOSITS CDs are issued by Banks and Financial Institutions. Risk factor associated with CDs gets reduced when issued by reputable institutions or Banks.
Following are the risk attached with debt securities: Credit risk, interest rate risk and currency risk
There are no fixed maturity dates in such securities, and asset’s value is determined by company’s performance. There are two major types of equity securities: common stock and preferred stock.
Common Stock: These are simple equity securities and bear no complexities which the preferred stock bears. Holders of such securities or instrument have the voting rights when it comes to select the company’s board of director or the business decisions to be made.
Preferred Stock: Preferred stocks are sometime referred to as hybrid securities, because it contains elements of both debit security and equity security. Preferred stock confers ownership rights to security holder that is why it is equity instrument
<a href="https://www.writofinance.com/equity-securities-features-types-risk/" >Equity securities </a> as a whole is used for capital funding for companies. Companies have multiple expenses to cover. Potential growth of company is required in competitive market. So, these securities are used for capital generation, and then uses it for company’s growth.
Concluding remarks
Both are employed in business. Businesses are often established through debit securities, then what is the need for equity securities. Companies have to cover multiple expenses and expansion of business. They can also use equity instruments for repayment of debits. So, there are multiple uses for securities. As an investor, you need tools for analysis. Investment decisions are made by carefully analyzing the market. For better analysis of the stock market, investors often employ financial analysis of companies.
1. Preparing Compliant
eCTD Submissions
Antoinette Azevedo, President
e-SubmissionsSolutions.com
DocTrain Life Sciences, Indianapolis, IN
24 June 2008
Copyright 2008 e-SubmissionsSolutions.com 1
2. Agenda
RTF Case Study
What Can Go Wrong?
How to Assure Compliance of Source
Files?
eCTD Workflow
Questions & Discussion
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3. Four Keys to eCTD Success
Content Process
Standards Technology
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5. The Guidance on RTF . . .
July 2006, US FDA, “Providing Regulatory Submissions in Electronic Format – Human
Pharmaceutical Product Applications and Related Submissions Using the eCTD
Specifications,” Revision 1, 7087rev.pdf.
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6. A Picture through Stock Price
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7. Summer 2005
Small California Biotech-- Submits NDA in eCTD
format to FDA CDER
eCTD publishing system
PDF toolkit
Electronic document management systems
Documentum
OpenText LiveLink
Consultants
PDF preparation
eCTD publishing & QC
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8. The Business Overview
NDA is company’s first candidate for
commercialization
Company is partnered with big pharma
who will assist with international sales
and marketing post-approval
Company hires 200 person sales force in
anticipation of approval
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9. Fall 2005
FDA issues Refuse to File (RTF) under
PDUFA timeline
Inadequacy of individual PDF files
Navigability of content of submission
Market capitalization drops 50%
overnight
Analyst conference call
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10. Early 2006
Small biotech prepares resubmission
Rework source files
Rework CTD folder/file structure
Rebuild XML backbone
FDA accepts resubmission for review
under PDUFA timeline
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11. May 2006
FDA issues “approvable” letter under
PDUFA:
Drug could be approved in future if certain
conditions could be met
“Conditions” to be determined in future
meeting with FDA
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12. June 2006
Big pharma company withdraws from
partnership
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13. July 2006
Small biotech lays off sales force
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14. August 2006
Small biotech lays off more than 100
additional employees
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15. September 2006
Small biotech has meeting with FDA
concerning “approvable” conditions
Additional studies required
Additional analysis required
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16. January 2007
Biotech announces plans to resubmit
NDA by 2Q2007
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17. August 2007
FDA accepts NDA for review
FDA sets PDUFA action date of
12 December 2007
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18. December 2007
Company Announces Sale and Leaseback
of Real Estate Assets
Deal valued at $109M
Net $61M after fees, expenses, etc.
Leases back corporate headquarters
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19. December 2007
FDA issues “approvable” letter under PDUFA
deadline:
Objective/subjective trial in elderly
Comparator safety study
Preclinical evaluation during 3rd trimester of pregnancy
Company cuts half its workforce
Company prepares meeting request to FDA
Ceases all clinical development and pre-
commercialization activities for candidate drug
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20. January 2008
Founder-President-CEO resigns after 14
years of service
Granted a formal meeting with FDA
during 1Q08 to discuss 2007 Approvable
Letter
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21. February 2008
Hope springs eternal . . .
$20.0 million upfront license fee paid for drug
candidate rights for Japan
Balance sheet assets of $276.7 million
10 indications
Three programs in Phase 1-2 for 7 indications
Three research programs
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22. What Can Go Wrong
with an eCTD?
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23. FDA’s Top 12 Issues for
eCTD Success*
12. SPL must be in “SPL” folder
11. Use elements and leaf titles correctly
10. Always reference all files in the XML backbone(s)
9. Include Module 1 in All eCTD Submissions
8. Make sure all application numbers are 6 digits
7. Make sure all sequence numbers are 4 digits
6. Do not use node extensions
5. Verify that all MD5 checksums are correct
4. All documents should conform to eCTD granularity
3. All XML must use standard components
*Source: Virginia Ventura, FDA CDERPDF hyperlinks & bookmarks
2. Be sure all Office of Business Process Support are correct
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1. Include TOCs in all PDF documents
24. Technical Issues with eCTD*
12. SPL must be in “SPL” folder
11. Use elements and leaf titles correctly
10. Always reference all files in the XML backbone(s)
9. Include Module 1 in All eCTD Submissions
8. Make sure all application numbers are 6 digits
7. Make sure all sequence numbers are 4 digits
6. Do not use node extensions
5. Verify that all MD5 checksums are correct
3. All XML must use standard components
*Source: Virginia Ventura, FDA CDER Office of Business Process Support
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25. Technical Issues with Source
Files*
4. All documents should conform to eCTD granularity
2. Be sure all PDF hyperlinks & bookmarks are correct
1. Include TOCs in all PDF documents
*Source: Virginia Ventura, FDA CDER Office of Business Process Support
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26. What is
CTD/eCTD? Module 1
Not part of CTD
Module 1
Regional Info
2.1 Table of Contents
2.2 Introduction
Module 2
2.3 2.4 Nonclinical 2.5 Clinical Summary
Overview Overview
Quality
Overall
2.6 Nonclinical 2.7 Clinical
Summary
Summary Summary
Module 3 Module 4 Module 5
Quality Safety Efficacy
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27. What is CTD/eCTD?
Submission
“nda121212”
Sequence “0000” with
5 modules
Sequence “0002” with
4 modules
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28. Where is XML Required?
“XML backbone”
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29. As the FDA Sees an eCTD
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30. Where is XML Required?
Module 1 Regional
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31. Where is XML required?
Structured Product Labeling
(SPL)
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32. Where is XML required?
Module 4 Study Tagging File
(STF)
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33. STF for Module 4
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34. Where is XML required?
Module 5 Study Tagging File
(STF)
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35. STF for Module 5
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36. Potential Problems with XML
Sponsor’s hand coding of XML
eCTD publishing vendor misinterpretation of
XML document type definition (DTD)
Sponsor’s usage of eCTD publishing system
eCTD publishing vendor not providing enough
guidance and control of user actions
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37. What is XML?
Document/data interchange standard
Originated from SGML/HTML
Replaces traditional submission table of
contents
Rules for individual instances contained
in Document Type Definitions (DTD) or
Schemas
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39. Challenges of eCTD:
The Numbers
According to FDA CDER:
NDAs will have multiple submissions over their life-
cycle
Of 10 most active eNDAs:
6 had 111 to 139 submissions
1 had 185 submissions
1 had 202 submissions
Of eSubmissions:
One initial submission had 5478 files
One eCTD supplement had over 15,000 files
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40. Challenges of eCTD
Document Authoring -- Creation of PDFs
highly dependent on use of word
processor
Templates
Styles
Cross references – how & to what
Within document
Outside document
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41. Challenges of eCTD
Granularity of content organization
Module 2: Quality, Nonclinical, Clinical summaries
Module 3: Quality
Module 4: Nonclinical study reports
Module 5: Clinical study reports
Regional differences
US
Integrated Analysis of Safety (IAS—formerly ISS)
Integrated Analysis of Efficacy (IAE—formerly ISE)
EU
Expert reports
CRFs – in or out
CRTs – in or out
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42. Challenges of eCTD
Collecting documents/data from study sites
Case Report Forms
Cost/time to convert to compliant electronic format
Consistency of organization
Changes of study protocol
Different CROs involved in different study phases
Electronic Data Capture (EDC)
Location of queries & data correction forms (DCFs)
Does my drug’s indication imply need to review CRFs?
Which CRFs will I need to submit?
Deaths/Drops/Serious AEs
All
Other
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43. Challenges of eCTD
Documents/data from study sites
Data
Can all the data be delivered in electronically-reviewable
format?
Can I convert from proprietary formats into SAS XPT
compliant formats?
Excel
Access
Other
Will the agency review my electronic datasets?
Stability
Nonclinical
Clinical
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44. Challenges of eCTD
Electronic Document Management Systems (EDMS) vs.
Shared File System
How do I know I have the final, approved document?
What if the final, approved document changes?
What is the effective version for a submission sequence?
Do I have the time/budget/resources to implement EDMS?
Will the EDMS meet the needs of my entire enterprise?
Will the EDMS integrate with my e-Submission publishing
process and tools?
How do I assure the EDMS is 21 CRF 11 compliant?
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45. eCTD Challenge: The Granularity
FDA CDER Study Tagging Files
Scope – nonclinical & clinical study reports
Lifecycle – from initial IND to product end-of-
life
Small unit of document granularity
Hyperlinking between files
Hyperlinking between submission serial numbers
A cultural change for most CROs and authors
Copyright 2008 e-SubmissionsSolutions.com 45
49. US, EU, Japan Experience To
Date
Problems with PDF Files
Lacking navigation aids:
Bookmarks
Hyperlinks
Document tables of contents
Absolute paths on hyperlinks
Security
File format
Incorrect granularity
Referencing proprietary style sheets
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50. Conclusion from Experience to
Date
System is needed to produce XML backbone
Source documents and data need to be
submission-ready & compliant with
requirements
Sponsors need intimate knowledge of the XML
output of their commercial-off-the-shelf (COTS)
systems
Sponsors must understand how agencies use
the components of an eCTD for review
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51. Four Keys to eCTD Success
Content Process
Standards Technology
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52. How to Assure Compliance
of Source Files?
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53. Credits & Disclaimers
MS Word templates courtesy Sage Submissions LLC
http://www.sagesubmissions.com/
MS Office version 2000 Professional
Adobe Acrobat 2007 Professional
http://www.adobe.com/products/acrobat/index.html
MS Windows XP Professional 5.1 (SP2)
ISIToolbox Pharma Edition 5.5.1
http://www.imagesolutions.com/Default.aspx?alias=www.
imagesolutions.com/isitoolbox
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54. Credits & Disclaimers
Enfocus PitStop Professional 7.01
http://www.enfocus.com/product.php?id=855
eCTD sample courtesy GlobalSubmit
http://www.globalsubmit.org/
Parsing/validating samples courtesy
GlobalSubmit & ING America
http://www.ingamerica.com/
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55. FDA Portable Document
Format Specifications
http://www.fda.gov/cder/regulatory/ersr/
PDF_specification_v11.pdf
Examples follow . . .
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56. PDF Version 1.4
Options:
“Reduce file size”
Output by EDMS
or eCTD
publishing system
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57. Embed Fonts
Not needed
for standard
font sets
Options
Converting
from MS
Word
Setting in
Acrobat
Distiller
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58. Embed Fonts
Options
Embed from within
Acrobat Standard or
Professional
Done on a text blocks
Not recommended
unless no other option
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59. Embed Fonts
Options
Enfocus PitStop
Professional
Done a line at a time
Not recommended
unless no other option
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62. Source of Electronic Document
Avoid scanning unless no other choice
Create PDFs from intelligent source
MS Office—Word, Excel, PowerPoint
Other word processors, spreadsheets, etc.
ASCII text
PDFs should be:
Searchable
Copy & paste to edit in other documents
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63. If You Must Scan
Document Type Resolution
Handwritten notes 300 dpi (black ink)
Plotter output graphics 300 dpi
Photographs—b&w 600 dpi (8 bit gray scale)
Photographs—color 600 dpi (24 bit RGB)
Gels and karotypes 600 dpi (8 bit grayscale depth)
High pressure liquid chromatography 300 dpi
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64. Lossless Image Compression
for Scanned Documents
Black & White Image Color & Grayscale
CCITT Group 4 Fax Zip/Flate
Reduce file size
No loss of data
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68. Hypertext Linking
Navigation improved for PDF documents
Hypertext links for:
Annotations
Related sections
References
Appendices
Tables or figures
For anything not located on same page
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69. Table of Contents & Hyperlinks
Hyperlinks designated by blue text or rectangles
with thin lines
Blue text for PDFs from intelligent source
Thin rectangles only option for scanned documents
Tables of Contents
Hyperlinked
Invisible rectangles and blue text preferred
eCTD publishing system can automate some
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71. Use Relative Paths for
Hyperlinks
eCTD publishing system should generate automatically
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72. Use Relative Path for Hyperlinks
However!
Acrobat still
shows relative path
Link report courtesy Image Solutions, Inc.
ISIToolbox Pharma Edition
Bookmark & Link Auditor,
Export Bookmarks and Links
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73. Bookmarks Hierarchy
= TOC Up to 4 Levels
eCTD publishing system should generate automatically
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74. Bookmarks & Hyperlinks
Magnification
= Inherit Zoom
eCTD publishing system
should generate
automatically
Link/Bookmark report courtesy
Image Solutions, Inc.
ISIToolbox Pharma Edition
Export Bookmarks and Links
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76. Initial View = Bookmarks & Page
eCTD publishing system should generate automatically
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77. File Naming & Folder/File Path
Use lower cases letters
Avoid special characters
except hyphens
File/folder path:
230 characters for full
folder/file path
64 characters for folder
names
eCTD publishing system
should generate/truncate
automatically
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78. Verbally Communicated
Requirements
Open to TOC
Optimize for Fast Web View
Font size
12 point font for text
10 point for tables (9.5 pt)
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79. Open to TOC Page
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81. Optimize for Fast Web View
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82. Institute Standards for Data
Inside and outside suppliers
Datasets – must have complete
documentation
Datasets table of contents
Variable definition file—complete
Datasets in SAS transport
Annotated CRF (for human studies)
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87. eCTD Single “Document” Workflow
Compile to
Collect Source Verify Single Files or Release for
Documents Completeness Study Tagging Files Publishing
& Data (STF)
If incomplete,
Incorrect, or
PDF Deliverables – Individual Files Content revised
Bookmarks & hyperlinks
Tables of contents
Pagination 1 through n
Optimized for fast web viewing
File Format 1.4
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88. eCTD Submission Workflow
Prepare Repository Insert Content in Insert Cross- Output
for Handoff eCTD Outline Document Hyperlinks for QC
Set Submission Adjust Submission
& Document & Document Issues?
Attributes Attributes
• Invalid XML
• Source document changed
• Dead or missing bookmarks or hyperlinks
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89. Components of an EDMS
Authoring
Client
Scanner
EDMS Server
Rendition Server RDBMS
for PDF Renditions & File Store
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90. Components of Submission
Publishing System e-Submission
Publishing
Client
File
Server
FDA
ESG
EDMS Server, Publishing Server,
RDBMS & RDBMS p-Submission
& File Store
Web
Server
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91. TimeLine for Implementation
Implementation Steps 1Q 2Q 3Q 4Q 5Q 6Q
Gather EDMS & eCTD system requirements;
determine validation requirements
Identify potential vendors; select short list
Prepare & issue RFP, reduce vendor list, start
negotiations
Order & install hardware; install EDMS software,
perform IQ/OQ validation
Train users, help desk, administrators; perform
EDMS UAT & PQ validation
Install & validate eCTD software. Produce small
submissions – INDs, Annual Reports, Amendments,
Supplements, Safety Updates
Produce marketing application & submit
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92. Consistency of
eCTD across ICH
Vendors’ ability to offer Sponsors’ systems
inexpensive solutions ability to manage
for multiple eCTD lifecycle metadata
markets’ requirements over drug’s lifetime
eCTD Critical Success Factors
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93. eCTD: Challenges to Sponsors
Return on Investment (ROI)
Cost of systems, training, process redesign
Cost of noncompliance
Speed, efficiency
Submission compilation
Agency review process
Lead time to application submission
On-going compliance
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94. eCTD: Benefits to Sponsors:
Electronic content for sponsor’s internal access
(Potentially) faster agency review
Higher quality agency review
Demonstrated lower cost of production
compared with paper
Faster time from database lock to submission
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95. Status of eCTD Requirements
FDA CDER
eCTD mandated January 1, 2008+ for electronic
submissions
CBER
Accepting both eCTD and eBLA
Sometimes e-submission mandatory (fast-track, rolling
submissions)
FDA CDRH
Guidances required
Informal pilots underway
Turbo 510K http://www.fda.gov/cdrh/cesub/index.html
Global Harmonization Task Force (GHTF) and STED
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96. Status of FDA ESG
e-Sub May 2006 May 2007 Feb 2008 Total
AERS 9,109 12,917 247,925
CDER 20 1,009 15,931
CBER 6 101 2,146
CDRH 153 75 3,364
CVM 414
Totals 9,228 14,201 269,780
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97. Business Case for ESG
1500 submissions (non-AERS)
Manual submission of electronic media &
supporting paper = $111,183
ESG startup (training, security certificates,
hardware) = $30,999 . . . $20.00+
Time/resource efficiency for Sponsor &
Agency
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98. Business Case Against Paper
10 copies, 100 volume submission
$163,290 Total
$147,000 = printing
$5,790.00 = binder materials
$10,500.00 = shipping
Does not include labor to assemble, page
stamp, manual TOCs, binding, QC, labeling,
packing
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99. Four Keys to eCTD Success
Content Process
Standards Technology
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100. Status of eCTD Requirements
EU/Japan/Canada
PDF reviewers’ aids accepted along with paper
volumes
eCTD dependent on each country’s information
technology infrastructure
Needs early & frequent communication to determine
ability to accept & review
Rest of World
Highly dependent on information technology
infrastructure to review e-submissions
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101. EMEA eCTD Statement of
Intent
1 July 2008 – accept eCTD or non-eCTD
electronic-only
1 January 2009 – strongly recommend eCTD or
non-eCTD; paper an exception
1 July 2009 – strongly recommend eCTD; paper
and other formats an exception
All applications (new and existing)
All submission types for Centralised Procedure
Rapporteurs & CHMP members receive no paper or
other electronic formats beyond this date
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102. Japan eCTD Experience
MHLW statistics as of December 2007:
Original Applications = 6 (13 sequences)
Reference Applications = 52 (70 sequences)
Total = 58 (83 sequences)
Free eCTD Validator
Integrating eClinical Trial and eSubmission
throughout drug development lifecycle
CDISC standars for clinical trial data
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103. Health Canada eCTD Transition
Phase 1 – Co-submission
Original Submission: eCTD Format on CD and DVD along with full
paper-based submission in CTD format
Subsequent Submissions: Continue use of both formats
Phase 2 - Hybrid submission
Original Submission: eCTD format on CD and DVD along with
Module 1 and 2 only in paper-based CTD format
Subsequent submissions: Submit Modules 1 & 2 in both formats
Original & Subsequent Submissions: Modules 3 to 5 may be subject
to print-on-demand requests
Electronic-only
Original Submission: eCTD format with no accompanying paper
Subsequent submissions: Do not revert to paper-based CTD
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104. Health Canada: Criteria for Participation in
the Hybrid Filing Format Pilot
Guidance January 25, 2006 December 31, 2007
Comparison (for pilot beginning on June 30, (effective immediately)
2006)
Candidate Submission has priority review status New Drug Submissions (NDSs),
submission Submission qualifies under the Abbreviated New Drug Submission
types Notice of Compliance with conditions (ANDS), Supplement to a New Drug
(NOC/c) policy Submission (SNDS), Supplement to a
Health Canada does not have Abbreviated New Drug Submission
capacity or ability to perform (SANDS)
electronic review NDS labeling only if the original
Submission to be assigned to a submission was filed in the co-submission
reviewer on contract or a teleworker or hybrid filing formats
Notifiable Change submissions and annual
updates of Notices of Change related to a
previously filed eCTD submission that was
filed in the hybrid filing format
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105. Health Canada: Criteria for Participation in
the Hybrid Filing Format Pilot
Guidance January 25, 2006 December 31, 2007
Comparison (for pilot beginning on June 30, (effective immediately)
2006)
Conditions Submission has Priority Review Health Canada does not have the
where status capacity and ability to perform an
candidate will Submission qualifies under the Notice electronic review
not be of Compliance with conditions Submission to be assigned to a
considered (NOC/c) policy reviewer on contract
Health Canada does not have the
capacity and ability to perform an
electronic review
Submission to be assigned to a
reviewer on contract or a teleworker
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106. Health Canada:
Implementation Considerations
Issue Co-Submission Hybrid Submission Electronic-only Submission
(Guidance Section 6.1) (Guidance Section 6.2) (Guidance Section 6.3)
Paper content Complete paper-based Modules 1 & 2 in paper No paper
CTD format
Legal record Paper-based submission eCTD submission eCTD submission
Signature Wet ink signature Digitized or scanned copy Electronic signature
required of signed document
Letter of Stating that material in Stating Modules 1 & 2 in Not applicable
Attestation eCTD format exactly eCTD format exactly
matches material in CTD matches material in CTD
Technical pre- Recommended Required To be determined
submission
consultation
Print on Not applicable <500 pages – done by To be determined
demand Health Canada
>500 pages – done by
sponsor on request
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107. FDA Status--Part 15 Hearing
Request for public input to influence development of new
policy/regulation
What do you think about an all-electronic submission
environment?
What do you think about implementing an electronic
platform to promote electronic sharing and exchange of
research and regulatory information?
Public rule being written to mandate electronic
submissions across all Centers of FDA—”years” to reach
final rule
RFI issued for public-private partnership to implement all-
electronic submission environment
http://www.fbo.gov/spg/HHS/FDA/DCASC/e-Platform-RFI/listing.html
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108. FDA Datasets Status -- Study
Data Tabulation Model (SDTM)
FDA Public Meeting February 1, 2005
http://www.fda.gov/oc/datacouncil/presentations.html
Steps being taken by FDA to require submission in electronic format:
Stability datasets – HL7
Animal datasets – tabulation & analysis-ready
Human datasets – tabulation & analysis-ready
Profound change from business as usual
Agency
Sponsors
CROs
Vendors
Additional resources:
http://www.cdisc.org/
http://www.hl7.org/
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109. FDA Status—Electronic
Submission Gateway (ESG)
May 2006 – implemented Electronic Submission Gateway
to enable fully-electronic bidirectional communication
http://www.fda.gov/esg/
If sponsor has electronic signature policy & technology in
place, no paper is required with submissions
Forms (1571, 356h) and documents which require
original wet signature on hardcopy
Acceptable formats
Scanned signatures
Digital signatures
Flattened digital signatures
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110. FDA Status--RPS
Regulated Product Submission (RPS) under
development
Create one model for submission of regulated product
information
Framework for sponsors to send regulatory information
Reviewers able to consistently locate requisite content
Animal and human products—human therapeutics,
medical devices, food additives, veterinary
Worldwide use
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111. FDA Status--RPS
Development under HL7
Randy Levin of FDA CDER one of three Co-Chairs
HL7 being recognized as standards body by ICH
Status
June 2005 RPS Project initiated
Sept. 2006 first test submission to FDA
2010+ implemented as extension to eCTD
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112. RPS--More Information
RCRIM’s TC:
https://www.hl7.org/Special/committees/rcrim/index.cfm
RPS Information Page
https://gforge.nci.nih.gov/plugins/wiki/index.php?Regulated%20
Product%20Submission&id=234&type=g
HL7 tools
https://www.hl7.org/Library/data-
model/V3Tooling/toolsIndex.htm
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113. FDA—SPL Resources
Providing Regulatory Submissions in Electronic
Format – Content of Labeling
http://www.fda.gov/cder/guidance/6719fnl.pdf
SPL Standard for Content of Labeling
Q&As
http://www.fda.gov/cder/guidance/7074fnl.pdf
FDA proposes to perform Indexing of SPL:
http://www.fda.gov/cder/guidance/7662dft.pdf
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114. FDA Data Standards Council
http://www.fda.gov/oc/datacouncil/
Structured Product Labeling
Drug Registration
Drug Listing
Regulated Product Submission
CDISC Data Standards
Stability Data Standards
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115. FDA Resources for CTD
Regulatory Submissions in Electronic Format –
General Considerations
http://www.fda.gov/cder/guidance/4156dft.pdf
eCTD Backbone Files Specification for Module 1
http://www.fda.gov/cder/regulatory/ersr/Module1Spec.pdf
eCTD Backbone Files Specification for Modules 2
through 5
http://www.fda.gov/cder/regulatory/ersr/module2-5spec.pdf
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116. FDA Resources for CTD
eCTD Backbone Files Specification for
Study Tagging Files (STF)--Module 4 &
Module 5
http://www.fda.gov/cder/regulatory/ersr/FDA%20implementatio
n%20of%20STFv2-6.pdf
Comprehensive Table of Contents
Headings and Hierarchy
http://www.fda.gov/cder/regulatory/ersr/5640C
TOC-v1.2.pdf
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117. FDA Resources for CTD
Study Data Specifications--Datasets
http://www.fda.gov/cder/regulatory/ersr/Studyd
ata-v1.3.pdf
Portable Document Format
Specifications
http://www.fda.gov/cder/regulatory/ersr/PDF_specification_v11.pdf
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118. Summary
EU & Japan & Canada – eCTD preferred format for
electronic; CTD required format for paper
US – CTD preferred format for paper
Rest of World-- ability to accept & review varies widely
eCTD preferred format for e-Submissions
eCTD remains optional except FDA CDER
Paper submissions required by most countries
Agency cannot legally accept electronic-only
Agency IT infrastructure inadequate to perform electronic
review
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119. eCTD Success! Critical Success Factors:
Faster time to market
Happier stockholders
Greater employee & management
satisfaction
Lower cost of production
Simultaneous global submissions
Healthier patients
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