Tips and Tricks for Effective eCTD Regulatory Strategy and eCTD Lifecycle Management

is being presented by Gina Ross, , Director, Quality Document Systems Management, with Beckloff Associates and airs on Tuesday, Novemeber 30th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

A sound regulatory strategy, combined with proactive lifecycle management of electronic submissions, can speed the regulatory review and approval process and reduce the regulatory burden, expand marketing applications to additional jurisdictions and drive successful regulatory approval outcomes.

To be truly successful at integrating regulatory strategy and eCTD lifecycle management, sponsors need to evaluate their existing document authoring and submission compilation activities and determine what, if any, modifications are necessary to accommodate the eCTD specifications. Document authors need to understand not only the CTD guidelines, but also have a working knowledge of the eCTD guidelines and application of the lifecycle operation attributes. Regulatory affairs and regulatory operations (i.e. publishers) need to have an in-depth knowledge of the CTD and eCTD guidelines, as well as the electronic requirements of multiple global regulatory agencies.

This audio conference is designed to help organizations and individuals understand the relationship between regulatory strategy and the eCTD lifecycle management, and to effectively develop systems, processes and procedures to support the chosen strategies and facilitate the future lifecycle management of applications.

Managing the Shift to Electronic Submissions

The electronic common technical document (eCTD) presents many challenges to a Sponsor organization, but may also yield significant benefits through increased efficiencies and improved reviews by regulatory agencies. Sponsor organizations that have decided to adopt the eCTD now have the challenging task of managing and implementing the paradigm shift from paper to electronic regulatory submissions.

The first of many challenges is to evaluate and modify existing document preparation processes to accommodate differences between paper and eCTD. Once these changes have been identified, the next step is to convince upper management the changes are necessary to move the organization forward to preparing electronic submissions. Another challenge is working with vendors to receive electronically-compliant documents. The eCTD requires sponsor organizations to rethink their business and those with whom they do business.

Managing the Shift to Electronic Submissions was presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates a Cardinal Health and aired on 2008-04-17. For more information, or to download this audio conference please visit our site at www.fxconferences.com

The "Why" and "How" of eCTD Conversions

Effective January 1, 2008, all electronic submissions submitted to FDA in the United States must be in eCTD format. This deadline is forcing organizations within the pharmaceutical industry to evaluate the transition from submitting paper documents to submitting electronic documents to global regulatory agencies.

The transition from paper documents to electronic documents encompasses many areas within an organization and integrates technology with regulatory requirements for submission and regulatory document preparation. This presentation highlights the things sponsors, CROs, testing facilities, and medical writers need to know about the impact of the eCTD on the industry and on their businesses.

The "Why" and "How" of eCTD Conversions was presented by Gina Ross, Director, Managing Consultant Regulatory Publishing Services, with Beckloff Associates a Cardinal Health Company and aired on 2008-01-31. For more details or to download this conference, please visit our site at www.fxconferences.com

Lifecycle Management of the eCTD and NeeS in Europe

With the multiple filing procedures in Europe, the eCTD presents many interesting challenges. Which filing procedure is most appropriate? Should a sponsor file individual submissions or combined submissions for the Reference Member State (RMS) and the Concerned Member States (CMS)? Which countries accept eCTD-only submissions, eCTD with a paper copy of one or more modules, or non-eCTD Submissions (NeeS)? What is the time line for all Reference Member States to accept eCTD submissions? In addition to the challenges of choosing the appropriate filing procedure, Sponsor organizations must also understand the concept of life cycle management for the eCTD and NeeS submissions. Unlike FDA, EU has specific requirements for tracking the submission life cycle management approach in Module 1, and the approach for lifecycle management is dependent upon which filing procedure has been selected.

Understanding what information needs to be provided to the RMS and CMS also represents unique challenges for the eCTD life cycle management. For sponsor organizations considering global submissions, the significance of understanding eCTD life cycle management is critical to ensuring a successful and smooth submission process.

Lifecycle Management of the eCTD and NeeS in Europe is being presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates and airs on Tuesday, April 21, 2009. For more details or to register, please visit our site at www.fxconferences.com

Electronic Submissions in Europe – eCTD and non-eCTD Submissions (NeeS)

December 31, 2009 is 385 days away. Why is this significant? European regulatory authorities are targeting January 1, 2010 for all national Competent Authorities(NCA) to accept eCTD-only submissions for marketing applications. In addition, for Sponsor organizations already filing eCTD submission in Europe, version 1.3 of the EU Module 1 specification for eCTD submissions is effective January 1, 2009. The EU Module 1 specification was revised in May 2008 to include section 1.10, Paediatric Information.

With the multiple filing procedures in Europe, the eCTD presents many interesting challenges. Which filing procedure is most appropriate? Should a Sponsor file individual submissions or combined submissions for the Reference Member State(RMS) and the Concerned Member States(CMS)? Which countries accept eCTD-only submissions, eCTD with a paper copy of one or more modules, or non-eCTD Submissions(NeeS)?

Now is the time for Sponsor organizations to recognize the true value of the eCTD for global regulatory submissions.

Electronic Submissions in Europe – eCTD and non-eCTD Submissions (NeeS)is being presented by Gina A. Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates and airs Tuesday, January 20th 2009. For more details or to register, please visit our site www.fxconferences.com

Managing the Shift to Electronic Submissions

The electronic common technical document (eCTD) presents many challenges to a Sponsor organization, but may also yield significant benefits through increased efficiencies and improved reviews by regulatory agencies. Sponsor organizations that have decided to adopt the eCTD now have the challenging task of managing and implementing the paradigm shift from paper to electronic regulatory submissions.


The first of many challenges is to evaluate and modify existing document preparation processes to accommodate differences between paper and eCTD. Once these changes have been identified, the next step is to convince upper management the changes are necessary to move the organization forward to preparing electronic submissions. Another challenge is working with vendors to receive electronically-compliant documents. The eCTD will require sponsor organizations to rethink their business and those with whom they do business.

This audio conference is presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, of Beckloff Associates a Cardinal Health Company. To learn more details please visit our site www.fxconferences.com