Boston Professional Events List


2017 workshop eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (COM)


Date
Nov 02, 2017 - 09:00 AM
Organizer
conference Manager
Location
DoubleTree by Hilton Philadelphia Airport , 4509 Island Avenue, Philadelphia, PA 19153, DoubleTree by Hilton Philadelphia Airport , 4509 Island Avenue, Philadelphia, PA 19153

Philadelphia,
Philadelphia,
Philadelphia,
ZIP: 19153
Phone: 347 282-5400

Ticket Price: Seminar One Registration - $1,295.00 Special Group Discount Register for Four attendees - $ 3885

An Interative Workshop Presented BY WCS & Peggy J. Berry, MBA, RAC, (Synergy Consulting)

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

Why You should Attend The Session 

This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD

Areas Covered

•    Overview of the drug development program and source of relevant submission documents
•    Discussion of the roles and responsibilities for CTD preparation
•    Review of the CTD format requirements
•    Discussion on the successful transition from other formats to the CTD
•    Placement of content into the CTD format; including less obvious items
•    Review of different requirements across regions (US, EU, Canada)
•    Implementing tools for the project management of CTD preparation and publishing
•    Technical requirements for an eCTD submission
•    Document naming requirements
•    Building the folder structure
•    Internal document requirements for the eCTD
•    Performi

Who will Benefit

•    Regulatory Affairs
•    Quality Assurance
•    Pharmacovigilance
•    Project Management
•    Regulatory Operations
•    Medical and Technical writers
•    Professionals preparing IND, DMFs, NDAs and other submissions
•    IT Professionals
•    Anyone responsible for providing content for the CTD

Learning Objectives

Regulatory Affairs, Quality Assurance, Pharmacovigilance, Project Management, Regulatory Operations, Anyone responsible for providing content for the CTD

 

Peggy J. Berry.MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

 

MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. 



Agenda


Course Outline:

(9:00 AM - 5:00 PM)

 

Day 01 (9:00 AM - 5:00 PM)

•    Registration Process - (8:30 am till 8:45 am)
•    Lecture 1: Overview of the drug development program and source of relevant submission documents
•    Lecture 2: Discussion of the roles and responsibilities for CTD preparation
•    Lecture 3: Review of the CTD format requirements
•    Lecture 4: Discussion on the successful transition from other formats to the CTD
•    Lecture 5: Placement of content into the CTD format; including less obvious items
•    Lecture 6: Review of different requirements across regions (US, EU, Canada)
•    Lecture 7: Implementing tools for the project management of CTD preparation and publishing

 

 

(9:00 AM - 5:00 PM)

 

•    Lecture 8: Technical requirements for an eCTD submission
•    Lecture 9: Document naming requirements
•    Lecture 10: Building the folder structure
•    Lecture 11: Internal document requirements for the eCTD
•    Lecture 12: Performing "pre-publishing" work for each document
•    Lecture 13: Tools for tracking and managing eCTD content
•    Lecture 14: Performing quality checks on the eCTD
•    Lecture 15: Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)

 



Speaker Details


Peggy J. Berry.MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

 

MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. 


Event Categories
Keywords: Educational, Learning




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