FDAnews Announces: Preparing for the New eCTD Mandates Workshop, June 10-11, 2014, Bethesda, MD

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FDANEWS

Apr 23, 2014, 03:00 ET


Falls Church, VA (PRWEB) April 23, 2014 -- Preparing for the New eCTD Mandates:
Mastering the Tools and Strategies
**Presented by FDAnews and e-SubmissionsSolutions.com**
June 10-11, 2014 – Bethesda, MD
http://www.fdanews.com/eCTDBethesda

Many drug, biologic and device companies utilizing eCTD can already measure a striking difference through increased first time acceptance rates, shorter FDA review times, speed to market and, increased revenue.

Indeed, the mandated move to eCDT is beginning to reveal its positive up side.

There's no doubt change is difficult. No one likes devoting endless hours to learning new processes while giving up comfortable old legacy systems and formats.

But there's a new wave of confidence within those companies that have taken the leap to eCTD, confidence in improved efficiencies, time and cost savings, increased speed in submission through use of ESG, easier access to eCTD submissions for internal due diligence and strategic research and, the attractiveness of advanced technology to potential investors.

And now, manufacturers can to can jumpstart the transition to eCTD by attending Preparing for the New eCTD Mandates: Mastering the Tools and Strategies on June 10-11, 2014.

Attendees will be able to take advantage of the vast experience of workshop leader Antoinette Azevedo, a leading software developer and expert in the use of technology to manage regulatory documents and publish electronic submissions. She'll provide real-world insights from implementing her system and producing eCTD submissions for global life sciences companies.

During this interactive workshop, attendees will gain amazing insights and knowledge, and have their toughest questions answered. Attendees will:

  • Discover the top 10 reasons sponsors receive a refuse-to-file from the FDA on their eCTD submissions, and the steps to take to avoid these conditions in source documents and the eCTD compilation process
  • Participate in breakout sessions where attendees will develop an eCTD strategy
  • Understand why and how to start producing eCTD submissions at the IND phase
  • Compare the similarities and differences between the eCTD format and CDRH’s Electronic Copy format.
  • Master the documentation requirements for electronic datasets for nonclinical and clinical studies and learn to better communicate these requirements to colleagues early in the drug development cycle
  • Understand how to impact the deliverables from outside suppliers, including contract writers, CROs and CMOs to assure the company is receiving submission-ready documents and datasets
  • Learn about cloud-based solutions for eCTD and EDMS that speed the time of implementation and reduce the cost of capital and validation services.

Preparing for the New eCTD Mandates on June 10-11, 2014 is an opportunity for "total immersion" in the extraordinary benefits for moving sooner, rather than later, to FDA-mandated eCTD submissions.

Meet the Presenter:
This workshop’s expert instructor, Antoinette Azevedo, founded e-SubmissionsSolutions.com in 2000 to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. She purchased Sage Submissions in 2007 to provide Sage Templates, MS Word-based eCTD templates, for authoring submission content. She co-founded RegDocs365 in 2013 in order to bring cloud-based solutions to small and virtual biotechs for content management and submission publishing.

Who Will Benefit:

  • Regulatory affairs
  • IT personnel who support regulatory staff
  • Dossier managers
  • Documentation/report services staff
  • R&D staff
  • Clinical affairs personnel
  • Medical writers
  • Compliance officers
  • Consultants/service providers/ regulatory operations managers
  • Data management and statistics personnel
  • Engineering and design control teams
  • Executive management
  • Managers
  • QA/QC personnel
  • Regulatory/legislative affairs professionals
  • Strategic planning and business development staff

Conference Details:
Preparing for the New eCTD Mandates:
Mastering the Tools and Strategies
**Presented by FDAnews and e-SubmissionsSolutions.com**
June 10-11, 2014 – Bethesda, MD
http:// http://www.fdanews.com/eCTDBethesda
Tuition: $1,797

Easy Ways to Register:
Online:http:// http://www.fdanews.com/eCTDBethesda
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]