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eCTD 2010 - Achieving Efficiency and Compliance in Electronic Submissions

 

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CHI’s Inaugural eCTD 2010: Achieving Efficiency and Compliance in Electronic Submissions will be held March 10, 2010 at the Crowne Plaza Philadelphia Downtown in Philadelphia, PA. This conference will be co-located with the Summit for Clinical Ops Executives (SCOPE), a four-day cluster of events taking place March 8-11, 2010. eCTD 2010 is co-hosted by CHI, Bio-IT World, and eCliniqua and is preceded by its partner events, CHI’s Second Annual Electronic Data in Clinical Trials, Third Annual Patient Recruitment in Clinical Trials and a short course on ‘Utilization of Electronic Health Record (EHR) Data in Clinical Research.’

Filing new submissions is time consuming and costly to both regulators and drug development organizations. Global regulatory agencies are committed to improving the approval process and the electronic Common Technical Document (eCTD) is seen as a practical solution. It has been mandated in some countries and, to date, over 30,000 eCTD sequences have been submitted to the FDA alone. Despite the promise of eCTD to move your data through the approval process more efficiently, there are challenges to adoption and implementation. This conference is intended to cover how to achieve efficiency and compliance in electronic submissions.

Wednesday, March 10, 2010

 

7:30 AM Conference Registration and Morning Coffee or Sponsored Breakfast Presentation (Sponsorship Opportunity Available)

8:30 Organizer’s Welcome & Chairperson’s Opening Remarks

Micah Lieberman, Exectuive Director, Conferences, Cambridge Healthtech Institute (CHI)

Joan Chambers, Senior Director Marketing & Operations, Publications, Cambridge Healthtech Institute (CHI), Bio-IT World, eCliniqua

8:45 How to Prepare Your Product Dossier for Global Simultaneous eCTD/CTD Submissions – A Look at Tools, Tips and Taking the Mystery Out of Submission Planning and Publishing

Meredith PurcellMeredith Sewell, Associate Director, Global Regulatory Affairs Publishing, Allergan, Inc.

Preparing to submit your product dossier to multiple regions as an eCTD and other regional formats can be a daunting task. Establishing and prioritizing timelines, planning, and writing documents for reuse and regional acceptability, and herding a seamless network of regional team members are crucial activities in a submission filing strategy. This session will demonstrate a clean well-organized approach to laying out the plan for a successful simultaneous filing, as well as show several tools and real-life process examples that can help your organization achieve submission milestones in multiple regions.

9:30 Case Study: Global Submission Management from Concept to Realization

Dominique LagraveDominique Lagrave, Senior Director, Regulatory Operations and Innovations, Novo Nordisk

The presentation will provide an in depth view of the journey that Novo Nordisk is taking from the company’s first simultaneous global eCTD submission two years ago and the current achievements in globalization activities. We will review the processes and technologies leveraged to support our long term vision and lessons learned during this project.

 

10:15 Networking Coffee Break and Exhibit Viewing

11:00 Taking eCTDs off the Critical Path to Drug Development

S. Albert Edwards, Pharm.D., RAC, Director, Regulatory Operations, Takeda

Concerns have surfaced over the time taken to prepare eCTDs, and the effect this might have on the time to submit applications. Management may ask that submission times be reduced. We will take a journey through how one company answered this request with metrics and look at some future opportunities to reduce cycle times for preparing eCTDs.


11:45 Interactive Panel: Looking Forward at Global Submission Management Across New Regions

The session will provide an update on submission requirements outside the ICH regions and how these new requirements will affect submission management, affiliate management, and technologies we used to create, publish, distribute, submit, and archive submissions.

Moderator: Dominique Lagrave, Senior Director, Regulatory Operations and Innovations, Novo Nordisk

S. Albert Edwards, Pharm.D., RAC, Director, Regulatory Operations, Takeda

Meredith Purcell, Associate Director, Global Regulatory Affairs Publishing, Allergan, Inc.

Donald Palmer, Associate Director, Regulatory Systems, Regulatory Affairs, MedImmune, Inc.

12:15 PM Luncheon Presentation (Sponsorships available. Contact Arnie Wolfson: 781.972.5431, awolfson@healthtech.com) or Lunch on Your Own

1:25 Chairperson’s Remarks

Joan Chambers, Senior Director Marketing & Operations, Publications, Cambridge Healthtech Institute (CHI), Bio-IT World, eCliniqua

1:30 Working with an eCTD Vendor: Best Practices and Lessons Learned

Thomas NotoThomas Noto, Vice President, Regulatory Affairs, Covance’s Periapproval Services

Writing, assembling, and submitting eCTDs is a very complex process. Working with outside vendors has the potential to add both time and complexity, potentially delaying filing. This presentation focuses on lessons-learned and best practices gained from over 15 years of electronic publishing experience. Recent experience includes the filing of a large eCTD containing over 250 study reports.

2:00 Electronic Signatures and Regulatory Processes, What the Agencies are Saying

Rich FurrRichard Furr, Head, Global Regulatory Affairs and Compliance, SAFE-BioPharma Association

This presentation provides an overview of the current positions of global regulatory agencies related to the acceptance of electronic signatures on documents which are components of e-submissions. The presentation also discusses the status of the eCTD in the EU in terms of the National Competent Authorities. The presentation provides a comparison between the different classes of electronic signatures with the emphasis on the type of signatures the Agencies are requiring and how sponsor companies can effectively meet those requirements.

2:30 Achieving Efficiency through Rounding Out Submission Standards: Format, Data, and Content Standards

Donald PalmerDonald Palmer, RAC, Associate Director, Regulatory Systems, Regulatory Affairs, MedImmune, Inc.

This presentation will look at how the CTD format standard and the CDISC data standards have improved global operations and registrations. It will then consider rounding out these submission standards with document and ultimately content standards. This rounding-out will be considered as a trend toward electronic submission efficiencies.

 
3:00 Networking Refreshment Break and Exhibit Viewing 

BREAK-OUT DISCUSSION GROUPS

3:45 Interactive Break-Out Discussion Groups

Concurrent break-out discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal yet informative format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format, please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

TABLE 18: Is Your Organization Moving toward Collaborative Authoring and Content Management?

Donald Palmer, Associate Director, Regulatory Systems, Regulatory Affairs, MedImmune    

• How can standards enable a shift from Document Management to Collaborative Authoring and Content Management?
• How do organizations deal with what is a new inter-department paradigm?
• What are the first steps?
• What are the greatest challenges and opportunities?

TABLE 19: In Search of Submission Efficiencies:  Is Your Organization Using Tools/Processes To Handle The Growing Workload of eCTDs?

S. Albert Edwards, Director, Regulatory Affairs Operations-US, Takeda

• Why are we being asked to do more with less?  Examining global industry pressures.
• How do organizations deal with the needs for increased efficiency?
• Internal Service Level Agreements?
• Cover Letter Templates? 
• Cover Letters eliminated?
• Electronic form management vs. paper forms?
• Other opportunities for Submission Efficiencies?

TABLE 20: Preparing for Future FDA, EU and ROW Initiatives for eCTD: What is ahead and what does it mean to you?

Meredith Sewell, Associate Director, Global Regulatory Affairs Publishing, Allergan, Inc.

• What is your organization’s method for keeping track of each country’s format requirements and relating it to your product licenses?
• How do you organize your submission assembly when you have a product application going to multiple countries in different formats, eg, NeES, paper, eCTD?
• How will you file eCTD in Australia (beginning pilot program in Q2 2010) and paper in New Zealand simultaneously?
• Do you have an overall strategy to convert paper to NeES, NeES to eCTD?

4:55 Closing Comments and Welcome to Reception

5:00 – 6:00 Networking Cocktail Reception and Exhibit Viewing

 

(Stay on for Drug Development Latin America Day Two)


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