eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day In-Person Seminar by Ex-FDA Official

By: Peggy J. Berry, MBA, RAC, President & CEO, Synergy Consulting (Ex-FDA Official)
Location :- Courtyard by Marriott Newark Downtown, NJ | Thursday, December 13, 2018 | Friday, December 14, 2018

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Course Description:

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

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 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
Day Two (8:30 AM – 4:30 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.)

Meet Your Instructor

Peggy J. Berry
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).

Venue

Location :

Courtyard by Marriott Newark Downtown
858 Broad Street,
Newark, NJ 07102, USA
Tel: 973-848-0070

December 13-14, 2018



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. GRC Seminars is not responsible for any inaccuracies in the same.
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$1,699

Seminar One Registration

December 13-14, 2018, Newark, NJ

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

The registration fee includes: the workshop; all related course materials; morning tea/coffee on both the days, lunch and afternoon tea/coffee on day one.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

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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 GRC Seminars 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.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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Newark Museum:
The Newark Museum, in Newark, Essex County, is the state's largest museum. It holds fine collections of American art, decorative arts, contemporary art, and art from Asia, Africa, the Americas, and the ancient world. Its extensive collections of American art include works by Hiram Powers, Thomas Cole, John Singer Sargent, Albert Bierstadt, Frederick Church, Childe Hassam, Mary Cassatt, Edward Hopper, Georgia O'Keeffe, Joseph Stella, Tony Smith and Frank Stella. The Newark Museum's Tibetan galleries are considered among the best in the world.

Prudential Center:
Prudential Center is a multi-purpose indoor arena in the central business district of Newark. Opened in 2007, it is the home of the National Hockey League's (NHL) New Jersey Devils and the NCAA's Seton Hall Pirates men's basketball team. The arena seats 16,592 patrons for hockey and 18,711 for basketball. Fans and sports writers have affectionately nicknamed the arena "The Rock" in reference to the Rock of Gibraltar, the corporate logo of Prudential Financial, a financial institution that owns the naming rights to the arena and is headquartered within walking distance. In December 2013, the arena ranked third nationally and ninth internationally for self-reported annual revenue.


Branch Brook Park:
Branch Brook Park is a county park of Essex County, located in the North Ward of Newark, between the neighborhoods of Forest Hill and Roseville. A portion of the park is also located within the Township of Belleville. At 360 acres, Branch Brook Park is the largest public park in the city of Newark. The park is noted for the largest collection of cherry blossom trees in the United States, with over 4,300 in more than fourteen different varieties collectively called Cherryblossomland, as well as its spectacular Cherry Blossom Festival each April. The festival attracts approximately 10,000 visitors each April.

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The Cathedral Basilica of the Sacred Heart, the fifth-largest cathedral in North America, is the seat of the Roman Catholic Archdiocese of Newark. It is located at 89 Ridge Street in the Lower Broadway neighborhood of Newark, New Jersey. Envisioned as a fitting monument to the faith, construction began in 1899 and was finished in 1954. which includes 154 ranks playable from two consoles.