Registration is now closed for this workshop. Please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or raps@raps.org for questions.
RAPS Interactive Workshop!
15-17 November 2010
Brussels
For the first time in Europe, RAPS brings you its popular interactive workshop, Preparing Compliant eCTD Submissions. This introductory workshop goes beyond theory and lecture to provide balanced demonstrations and hands-on exercises on neutral platforms illustrating best practices and skills required to successfully produce eCTD submissions. Get the tools and information you need to master the electronic Common Technical Document (eCTD) for Europe and the US!
Programme Description
Every regulatory professional should know the standards, groundwork, expertise and technology required to prepare an electronic submission within Europe and the US. The eCTD has become the standard for numerous regulatory agencies around the world, mainly because it is cost effective. It guarantees a faster response from the recipient regulatory agency, reducing time-to-market for businesses.
The European Medicines Agency now requires eCTD format for Centralised Procedure applications (beginning 1 January 2010). The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research has required electronic submissions in eCTD format since 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 implemented an electronic review environment for eCTD submissions 1 January 2010. All regulatory authorities who receive eCTD submissions are reporting serious problems with lack of compliance to the electronic format and difficulty navigating the electronic files that comprise an eCTD, which prevent the authorities from conducting their review.
RAPS offers this impartial introductory two-and-a-half day eCTD workshop for participants to learn the proper techniques for preparing compliant eCTD submissions and to learn guidelines to make the process easier for you and your organisation.
Learning Objectives
At the conclusion of this meeting, participants should be able to:
- Identify fundamental strategies for preparing compliant eCTD submissions, including techniques for document reuse and repurposing for simultaneous global 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 an EU eCTD, as well as a US eCTD that is compliant with CDER requirements
- Facilitate the transition to electronic submissions within your organisation
Who Should Attend?
This programme 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 pre-requisite to participate.
Put yourself and your company steps ahead of your competitors. Several similar programmes have sold out, so register today to ensure your space!
Instructors
Antoinette Azevedo, president, e-SubmissionsSolutions.com, founded the organisation 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 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.
Hans van Bruggen Msc, director of Qdossier, has many years of practical regulatory experience in the pharmaceutical industry. Van Bruggen led the successful submission and validation of the first eCTD for an initial Marketing Authorisation Application worldwide for a new chemical entity. He has a wealth of experience, specializing in first time right eCTD lifecycle management and has built up a solid reputation within the pharmaceutical industry and agencies.