Preparing for the New Global Requirements for eCTD and Regulated Product SubmissionsMastering the Tools and Strategies
Paper submissions are losing traction and that's no secret. Every day, regulatory authorities across the globe are turning to electronic submissions as their new preferred format ... and the FDA is leading the way.
With RPS (Regulated Product Submission) poised to build on the eCTD standard, if you don't yet have your electronic submission process perfected, there's no time to lose.
Many drug, biologic and device companies can already measure the difference in dollars, through increased first-time acceptance rates ... shorter FDA review times ... and yes, speed to market.
Your colleagues and competitors have found the key.
You can, too, in this hands-on workshop that gives you the eCTD tools and tactics to satisfy any regulator worldwide, plus prepare for RPS.
Don't delay. Register now and mark your calendar for Preparing for the New Global Requirements
for eCTD and Regulated Product Submissions.
Attend Preparing for the New Global Requirements for eCTD and Regulated Product Submissions and you will:
- Discover the top 12 reasons sponsors receive a refuse-to-file from the FDA on their eCTD submissions and steps you should take to avoid these conditions in your source documents and eCTD compilation process
- Gain clarity on the acronyms and jargon of eCTD and electronic submissions
- Effectively budget for all scenarios of eCTD production — outsourcing, in-house publishing or a combination
- Develop project plans for eCTD submissions
- Understand why and how to start producing eCTD submissions at the IND phase
- Master the documentation requirements for electronic datasets for nonclinical and clinical studies and 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 your company is receiving submission-ready documents and datasets
- Assure the output of your outsource vendor or in-house eCTD system is valid for FDA review
- Learn about the eCTD pilot — what it does, why you need it, how it works and how to make it work for you
- Learn about the FDA's Electronic Submissions Gateway (ESG) and how to prepare to submit your eCTDs electronically, including unique requirements the ESG imposes on your eCTD publishing process
- Create quality control checklists for documents and data to be included in your eCTD application
- Develop a cost-justification for outsourcing and know how to control your budget and avoid out-of- scope charges when outsourcing your eCTD
- Develop a business case for purchasing an eCTD system and electronic document management systems (eDMS) as part of your total solution for eCTD submissions
- Analyze cost and timelines for selection, implementation and validation of eCTD publishing systems and understand who the vendors are and their products' distinguishing characteristics
- Understand the interdependencies of submission life cycle and document management systems in combination with eCTD publishing systems and the importance of submission life cycle management
- Preview eCTD: The Next Generation — Regulated Product Submissions (RPS)
- Participate in breakout sessions where you'll develop an eCTD strategy for your company
walk away from this interactive workshop with presentation slides
Here's what previous attendees have to say:
"Antoinette is extremely knowledgeable regarding needs across the industry."
Kristina Oaks, Report Coordination Supervisor, SNBL USA
"Antoinette's expertise in the fields of document
management and electronic publishing is unquestionable. She understands all of the potential hurdles —
not just current FDA/ICH standards, but also hardware issues, software issues, IT support, need for document control and even the struggles with
internal resistance to standardization and change. This is truly her niche, and she is able to customize the approach and the solutions to fit a wide variety
of companies, projects and needs within the pharma/biotech industries."
Kathleen Gibbon, RAC Senior Director, Regulatory Affairs, Avera Pharmaceuticals
"Antoinette knows the topic well, was very helpful and open to questions and
suggestions. She led the discussion well and provided a wealth of information. The workshop materials were very comprehensive with good handouts, takeaways
and valuable tools."
Peter Prince, Director, Regulatory Submissions, Hoffmann–La Roche