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.

Electronic Drug Establishment Registrations and Drug Listings – One Year Later

is being presented by Dr. Greg Onyszchuk, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates, Inc. and airs on Wednesday, October 6th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

New FDA requirements for electronic drug establishment registrations and drug listings took effect June 1, 2009. Many firms were initially surprised by the challenge and complexity of electronic drug establishment registrations and drug listings. The challenges continue, as new validation rules are implemented, and as scrutiny of file content increases.

To make successful submissions, firms must not only have a technology solution in place (ESG account and SPL R4 file preparation and editing software), they must have a comprehensive understanding of file content requirements, of typical validation errors and how to avoid or overcome them. All of this may be accomplished through internal efforts or with help from a service provider.

This audio conference provides an overview of the current FDA requirements for drug registration and listing, and shares valuable insight gained over the past year.

Optimizing Regulatory Compliance Throughout the Drug Development Process

is being presented by Dr. Ruth Ann Lee, Director and Executive Consultant, Scientific Consulting, with Beckloff Associates, Inc. and airs on Tuesday, April 20, 2010. For more details or to register, please visit our site at www.fxconferences.com

Compliance is not passive! The regulatory agencies expect you to continuously evaluate and monitor your state of compliance, maintain compliance, and ensure sustained compliance. By understanding the interplay of regulations as the drug substance and drug product transition from lead compound through final commercialization, a drug development program can be optimized to prevent delays that can result in lost time, delayed return on investment and a shorter market life cycle.

This audio conference provides an overview of the regulatory compliance requirements through the various phases of product development. The speaker discusses the take-away message from current FDA compliance activities and present options to prevent, respond, and remediate compliance issues as necessary.

Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway

The new FDA requirements cover both the format (SPL Release 4 files) and the submission modality (via the FDA Electronic Submissions Gateway – ESG) for electronic drug establishment registrations and drug listings, imposing a double electronic challenge upon all firms who must register and list. As of June 1, 2009, paper forms FDA 2656 and FDA 2657 are no longer acceptable. Many firms have been surprised by the challenge and complexity of electronic drug establishment registrations and drug listings. Headaches and frustrations with the tools, the process and the content are increasing as the end of 2009 approaches.

To meet an end-of-year deadline, firms must have a solution for ESG connectivity in place, as well as a means to prepare and validate their SPL R4 files. Most importantly, they must have a solid grasp of the content necessary to produce compliant drug registrations and listings. In this session, the speaker provides practical advice regarding SPL-R4 file content, submissions and validation.

Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway is being presented by Dr. Greg Onyszchuk, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates, Inc. and airs on Thursday, October 22, 2009. For more information about this audio conference, or to register please visit our site at www.fxconferences.com

Optimizing Your Chemistry, Manufacturing & Control Program

Chemistry, Manufacturing, and Controls (CMC) programs are an integral part of the development process which brings a drug from the preclinical phase to the market. Without a CMC program that is properly integrated with the clinical, non-clinical, and marketing programs, the entire development cycle can be delayed, resulting in lost time, revenues and market life cycle. However, the extent of necessary activities in CMC programs can vary depending on the development phase of the drug.

In this audio conference we explore how the skillful combination of drug characterization, manufacturing and packaging processes, analytical test methodology, compliance with applicable regulations and adequate documentation all help to ensure that the CMC portions of an application meet the necessary requirements, as well as supporting the clinical and nonclinical studies being performed to establish the safety and efficacy of the drug.

Optimizing Your Chemistry, Manufacturing & Control Program is being presented by Dr. Miguel de Soto-Perera, Vice President of Pharmaceutical Sciences, with Beckloff Associates, Inc. and airs on Wednesday, June 10, 2009. For more details or to register for this event, 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