• Review of FDA and ICH guidance for NDAs/BLAs
• Strategies for Navigating the Submissions and Review Processes 
• Supplements and Reports
• Examining the Basic CTD Format (Modules 1—5) 
• Considerations for Regional Differences
• Content Preparation Considerations for Modules
• Best Practices for CTD Project Coordination and Management
• Current Issues for eSubmissions to Health Canada and the FDA
• Considerations for Applying Tools and Software for eCTD Submissions
• Strategies and Steps for Transferring to Electronic Format
• Validations Issues, Requirements and Tools
• Best Practices for Producing/Publishing a BLA/NDA in eCTD Format
• Filing eCTDs and Administering eSubmissions
• CTD and eCTD Life Cycle Management 
• Co-Authoring and Preparing Submission-Ready Documents
• Organizational impact of transitioning to eCTD

Ms. Peggy J. Berry Head of Quality & Regulatory Affairs Amarin

Peggy J. Berry, MBA, RAC, Vice President, Head of Quality & Regulatory Affairs at Amarin where she is responsible for the strategic management and oversight of the regulatory affairs, quality, & pharmacovigilance departments. She has more than 20 years of experience in drug development and regulatory affairs including senior level positions with Dyax Corp, AstraZeneca, and Dey Pharmaceuticals and roles at two clinical contract research organizations (ILEX Oncology and Cato Research Ltd.) as well as project management work in review divisions at the FDA. She has a BS in Biology and an MBA.

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Ms. Candis Edwards Generic Drug Solutions Inc.

Day 1 - Tuesday March 23, 2010
08:00 AM	Registration and Continental Breakfast
08:30 AM	Review of FDA and ICH Guidance for New Drug and Biological License Applications
	FDA Electronic Submissions Guidances and Technology Foundations pdf SAS xml ICH and Canadian Guidance for Electronic Submissions
09:15 AM	Examining the Basic CTD Format: Modules 2-5
	Module 2 Summaries and Overviews Granularity and Use Module 3 Authoring to new standards Module 4/5 Study Reports Study Tagging Files Legacy reports Data requirements for US Case Report Forms
10:30 AM	Mid-Morning Refreshment Break
10:45 AM	eCTD Tools and Software
	Developing eCTD Software User Requirements Implementing eCTD Software in-house Outsourcing eCTD Submissions Hosted / Software as a Service (SaaS) eCTD Software
12:15 PM	Luncheon
1:15 PM	Validation Issues, Requirements and Tools
	Tools for Validating eCTD Submissions Common Validation Issues How to Avoid Problems Quality Considerations for eCTD Submissions
2:15 PM	Strategies for Navigating the Submissions and Review Process
	eCTD Demonstration in a Viewing System Use of Good Review Practices
3:30 PM	Mid-Afternoon Refreshment
3:45 PM	Filing eCTDS and Administering eSubmissions
	Preparing a Sample eCTD Submission Setting up Electronic Submission Gateway (ESG) Capabilities with the Food and Drug Administration Considerations for eCTD IND submissions Best Practices for Maintaining eCTD submissions
4:30 PM	Questions & Answers
4:45 PM	Conclusion of Day 1
Day 2 Wednesday March 24, 2010
08:00 AM	Continental Breakfast
08:30 AM	Co-Authoring and Preparing Submission-Ready Documents
	Setting up Electronic Document Management System (EDMS) or Network Fileshare for Submission Authoring Standardized CTD Templates and Style Guide Establishing Publishing Standards and Quality Reviews Proper Document Granularity
10:00 AM	Mid-Morning Refreshment Break
10:15 AM	Organizational impact of transitioning to eCTD
	Understanding the Impacts and Benefits of eCTD Business Process Transition Information Technology (IT) Infrastructure Impact Regulatory and IT Skill Sets
11:00 AM	Best Practices for Producing and Publishing a BLA/NDA in eCTD Format
	Developing an Overall Submission Tracker Performing a Submission Component Gap Analysis Generating Submission Metrics Meeting Deadlines Publishing Strategies by Module Quality Considerations
12:00 PM	Luncheon
01:00 PM	Current Issues for eSubmissions to FDA and Health Canada and Considerations for Regional Differences
	eCTD Pilots eCTD Validation File naming conventions Leaf titles
02:00 PM	eCTD Lifecycle Management
	Use of Operators Scenarios Implications on Authoring
03:15 PM	Questions & Answers
03:15 PM	Conclusion of Program

This two day interactive program is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biopharmaceutical, and allied industries with daily responsibilities involving:

• Regulatory Affairs
• Quality Assurance
• Quality Compliance
• Submissions Management
• Documentation
• Medical Writing
• IT Systems
• Validation
• Electronic Publishing
• Project Management
• R&D
• Records Management
• Medical and Clinical Affairs
• CMC

 

Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

Cancellation/Substitutions Policy:

All cancellations are subject to a USD $150.00/person processing fee. To receive cancellation credits for attendance at an upcoming course, IPA must be notified of the cancellation in writing (by email, mail or fax) up to 3 weeks prior to the program start date. Cancellations submitted less than 3 weeks prior to the event will not be qualified for refund or credit. Substitution of delegate/s with the member/s of the same organization is permitted at any time with no penalty.

IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.

Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, Pennsylvania, USA 19153 Tel: 1-215-365-4150 Fax: 1-215-937-6382 A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention IPA to receive the reduced room rate. For more information, please call us at 416-410-7402 or enquiry@ipacanada.com