2-Day In-Person Seminar by Ex-FDA Official

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada

BY: Peggy J. Berry,

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

December 13-14, 2018
Newark, NJ
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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.

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.

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

Agenda

Day 01(8:30 AM - 4:30 PM)
  • 08.00 AM - 08.30 AM: Registration
  • 08.30 AM: Session Start
  • 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
Day 02(8:30 AM - 4:30 PM)
  • 08.00 AM - 08.30 AM: Registration
  • 08.30 AM: Session Start
  • 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.)
Robert J. Russell
Peggy J. Berry 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. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

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$1,699.00

Seminar One Registration

December 13-14, 2018, Newark, NJ


Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.
For discounts on multiple registrations, contact customer care at +1-888-771-6965.

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Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future FDATrainingAlert event and a credit note will be issued.

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We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

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How to Reach »

General Driving Directions:

Driving Directions from Newark Liberty International Airport - EWR: 3.9 miles N
  • Head northeast on Buses toward Express Rd.
  • Travel 0.5 miles and take a slight right.
  • Travel 0.2 miles. Keep LEFT at the fork, follow signs for US-1 N/US-9 N/US-22/NJ-21.
  • Travel 0.5 miles and continue on the ramp.
  • Take a slight left toward NJ-21 N.
  • Travel 0.3 miles and keep right at the fork and merge onto NJ-21 N. Travel 0.7 miles and exit onto Broad St.
  • The hotel will be 1.3 miles ahead on the right.

Other Transportation:

Bus Station
  • Newark Penn Station - 0.7 miles NE

Train Station
  • Newark Penn Station - 0.7 miles NE

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
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  • Speaking opportunity
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For more details and other sponsorship options at this event, please contact Event Manager: customercare@fdatrainingalert.com or call: +1-650-238-9656

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