RPI Presents at BioPharma PM Meeting: Driving Your Team to Prepare a Successful eCTD

January 21, 2011. San Francisco, CA

RPI presented at the BioPharmPM breakfast meeting on tips for leading your team to a successful eCTD submission.

This presentation touched on LEAN Concepts that will help you to reduce downtime, improve quality, optimize efficiency through streamlining processing, minimizing over production and maximizing employee utility.

Presentation Components
• Overview of the eCTD (i.e., the new standard)
• Laying out the roadmap
• Preparing the eCTD
o Identifying and evaluating key external partners
o Agreeing on the content
o Gaining FDA buy-in
o Managing the document review/approval process
o Agreeing on submission plan mgmt
• eCTD Publishing
o Nuts & Bolts of publishing - a behind the scenes view
o Gaining agreement on the process
o Building quality into the process (QC)
Managing Risks
o Identifying, prioritizing and weighting of risks
o Understanding implications of risks
o Developing mitigation plans
o Managing Lessons Learned
• Road Signage - Navigation and Communication Tools
o Developing Project Statements & Key Messages
o Producing Communication Plans
o Managing Information Storage & Sharing
o Providing Status Updates
• Timelines: For the broader effort and specific deliverables


For a copy of this presenation, please visit the BioPharmaPM website www.biopharmapm.org

RPI to Speak at NorCal BioPharmPM Breakfast Meeting

Date/Time: Friday November 19, 2010/8:00-10:00, presentation at 8:30 sharp

Place: Rinat-Pfizer (old Proteolix bldg)
230 E. Grand Avenue
South San Francisco, CA 94080

Cost: Attendance is Free. No membership required

Topic: Leading Virtual Project Teams in a Global Environment

Donna Kato of RPI and colleagues from Genentech will present case studies on the challenges of working on virtual project teams across the globe. We will also explore examples of vendor and alliance managment.

Donna will share recent experiences and helpful insights on the regulatory aspects to consider when working in Virtual Global Teams in a pre-approval setting. Case studies will include insights on managing multinational trials.

Today Oct. 25, 2010, Regulatory Professionals, Inc. exhibited at the 2010 RAPS Annual Conference in San Jose, CA. Afterwards, RPI hosted a cocktail reception. Our Japanese regulatory affiliate, Tomoko Ohmae from PRARD and our IT specialist, John Vlahos of SFBay IT (one of the best), also attended.

The RAPS meeting was small but the attendees were enthusiastic. RPI exhibited on a wide range of regulatory services, but featured two new services at the conference: Electronic Publishing (eCTD) and CTD Preparation Services.

RPI has extensive submission experience and provides a wide range of support levels to supplement existing scientific and regulatory staff. Our range of services continues to grow with the introduction of electronic regulatory submission capability, allowing RPI to provide full service regulatory affairs support for the product life cycle in the highly desired eCTD format.

RPI has a proven history of helping sponsors file high quality CTDs that are on-time, on-budget and are of the highest caliber. With a thorough knowledge of the CTD structure, content and FDA's review process, RPI offers creative approaches to handling critical path activities that keep the CTD submission on track. With CTD Preparation Services, RPI performs an assessment of the available CTD resources and identifies resource gaps that stand between the sponsor and a successful CTD submission. Critical resource gaps are filled and the CTD preparation process is effectively managed from kick-off through submission. Further information about CTD Preparation Services will be posted on future blogs.