Webinar: eCTD as part of integral Electronic Document and Content Management System
Sponsored by: Infotehna
Focused on:
Date: 7th December
Days old: 4809
Time: 3PM London / 10AM New York
An in-depth discussion of advantages in integrating eCTD publishing with corporate-wide EDMS
Many companies thought that by acquiring electronic Common Technical Document (eCTD) publishing software, all of their submission problems will be solved. Unfortunately, after ten or more sequences it becomes clear that the connection between original documents and published eCTD is lost, and they continue with life of their own. Initially copied document may have gone through several versions, but in eCTD it is still the first one, which was copied. And vice versa, based on regulatory agencies requirements, RA personnel changed some documents (in most cases specifications) without letting it be known to the document author. In both cases the result is the same – serious problem.
How to overcome this? By introducing integral, company-wide EDMS, with eCTD publisher just a tiny part of it. In this case, every single document has a lifecycle of its own, which is reflected in eCTD structure, since the documents are not copied, but linked in eCTD. What does it mean? It means that for each document there is only one, valid version in the system. Each document is typically owned by its author, who knows everything about it. If the document has to be changed, change request is issued by interested party, and the author changes the document accordingly. On the other hand, if the document is changed by the author because of departmental needs, he can see where this document is used (specification for excipient can be used in hundred of dossiers) and act accordingly. At the same time, compiler of the dossier will see that the old version of the document is linked in the dossier, so he can either leave it or change to new version, as the situation requires.
In this way, dossier will always be up to date, only qualified persons will be able to make changes, and managing of eCTD lifecycle will become much easier.
Presented by
Mihajlo Ceraj Ceric, MSc. Pharm.,
Former Director, Pliva (Teva Group member)
Mihajlo Ceraj Ceric is founder and CEO of MCC Consulting, specialized advisory agency for pharmaceutical companies. Prior to his successful private venture, he was 3 decades associated with PLIVA (Teva Group member) where he held a number of managerial posts. Serving on such diverse positions as R&D director, Head of pharmaceutical investments, RA director and Deputy to QA/QC director enabled him to achieve comprehensive and in-depth understanding of business critical processes in pharmaceutical company. After leaving Pliva (Teva Group member) he spent 10 years in INFOTEHNA Group as Life science Director.
Mr. Ceric has particular interest in enterprise content management, and is one of the industry’s top experts in document and processes management. As a consultant he specializes in business process analysis, pharmaceutical procedures streamlining and optimization of electronic document management systems.
Mr. Ceric is also a very prolific author, who has written numerous articles on enterprise content management issues in modern pharmaceutical organizations, and is regular presenter or chair at pharma conferences.
Sinisa Belina, MSc. Pharm.,
Product development, Process improvement
Mr. Belina started his professional career in PLIVA (TEVA Group member), renowned for its highly competent employees, innovative technologies and continuous investments in production. In addition to his responsibilities in manufacturing, he was part of the very successful Electronic Document Management System (EDMS) implementation project.
In 2007 he joined KRKA, one of the largest generic pharmaceutical companies worldwide, where he worked in Regulatory Affairs department. With years of experience in pharmaceutical business, Sinisa moved to INFOTEHNA as a Life sciences consultant and then he was promoted to Business Services Deputy Director. He applies his detailed knowledge of pharmaceutical documentation and processes principally to areas of business process analysis and optimization of electronic document management systems.
Download Slides
Please login to download the slidesKey Learning Objectives
- eCTD alone does not solve all of the submission problems
- eCTD lifecycle should be related with single documents lifecycles
- Authors should be owners of each document
- Documents should be in the system only once – no copying
Audience
- Regulatory affairs managers
- RA experts
- Publishing experts
- R&D managers
- R&D experts
- QA managers
- QA experts
- QA/QC managers
- QA/QC experts
- IT managers