A RAPS interactive workshop!
14–15 August 2012
RAPS Training Center
Rockville, MD
Roll up your sleeves for a two-day, unbiased, introductory workshop, including skill-building, interactive exercises, case studies and small group discussions, to learn how to prepare an effective electronic Common Technical Document (eCTD) submission on any platform.
Every regulatory professional should know the standards, groundwork, expertise and technology required to submit an electronic submission within the US and globally. Due to its cost effectiveness, and because it guarantees a faster response from the recipient regulatory agency, reducing time-to-market, the eCTD has become the standard for numerous regulatory agencies around the world.
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has required electronic submissions in eCTD format since 1 January 2008 and, as part of the most recent version of the Prescription Drug User Fee Act (PDUFA IV), is implementing a single electronic review environment for all FDA centers by 2013. In addition, Health Canada has implemented an electronic review environment for eCTD submissions and the European Medicines Agency (EMA) has required eCTD format for Centralised Procedure applications since 1 January 2010. Some regulatory authorities in Europe have implemented electronic-only review environments and are now refusing to accept paper submissions. All regulatory authorities who receive eCTD submissions are reporting serious problems with lack of compliance with the electronic format and difficulty navigating the electronic files that comprise an eCTD, which prevent the authorities from conducting their review.
What makes the RAPS eCTD training unique? Gain from:
- An introduction to EU submissions using the eCTD format
- A critical comparison of how EU and US submissions differ
- Tips on successful integration methods for eCTD culture within your department
- Instructor-led, hands-on exercises in best practices in MS Word and Adobe Acrobat Professional
- A step-by-step demonstration creating an eCTD project, settting submission metadata, linking documents and setting content metadata, and creating lifecycle sequences*
- Working session on conducting an eCTD Readiness Assessment
Put yourself and your company a step ahead of competitors by mastering the eCTD. Several previous similar programs have sold out, so register today!
Learning Objectives
At the conclusion of this workshop, participants should be able to:
- Identify fundamental strategies for preparing eCTD submissions
- Explain how eCTD differs from previous electronic submission formats and the technical requirements of an eCTD submission
- Discuss the content of the technical modules and demonstrate best practices in the use of MS Word and Adobe Acrobat in preparing content for eCTD submissions
- Submit a US eCTD that is compliant with CDER requirement, as well as an EU eCTD
- Facilitate the transition to electronic submissions within your organization
Who Should Attend?
This program is intended for entry to mid-level regulatory professionals who want or are required to become more familiar with the role, benefits and challenges of eCTD submissions.
The material is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in preparing electronic submissions, particularly medical writers, regulatory operations, submissions publishing and IT staff. There is not a prerequisite to participate.
Instructor
Antoinette Azevedo, president, e-SubmissionsSolutions.com, founded the organization in an effort to advise biotechnology and pharmaceutical companies on the use of technology to manage regulatory and controlled documents and publish electronic submissions and registrations. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Previously, Azevedo was director of west coast operations for Liquent and principal consultant in CSC Consulting’s life sciences practice. Azevedo's experience ranges from developing strategies for document management and electronic publishing, to implementing fully-validated systems accepted by regulatory authorities worldwide.
Key Program Goals
- Explore best practices with software used to generate electronic submission content (MS Office & Adobe Acrobat).
- Decipher acronyms and master the jargon surrounding eCTD and electronic submissions.
- Navigate technical requirements of the content of an eCTD submission.
- Transition your company into submitting in the eCTD format for both IND stage submissions as well as marketing applications
- Effectively produce and review eCTDs to minimize the chance of Refusal to File (RTF) action by FDA.
- Learn about EU submissions and procedures and how eCTD is different in the US and the Europe
* RAPS does not endorse any publishing systems or vendors. All eligible systems have been placed in a rotation pool and will be demonstrated upon its turn.