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

By: Peggy J. Berry., MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).
Product code: SEM26
Location 1: Philadelphia, PA Nov 02 - 03

Description

Course"eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (COM)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

"Each attendee will receive 2-Day workshop materials ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee provided by WCS. "

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

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

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. 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).

02-November-2017 To 03-November-2017 Philadelphia, PA
Seminar One Registration
$ 1295



Special Group Discount Register for Four attendees
$ 3885

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

2 Attendees - 5% off

3 to 6 Attendees - 7% off

7 to 10 Attendees - 15% off

10+ Attendees - 20% 0ff

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DoubleTree by Hilton Philadelphia Airport  4509 Island Avenue, Philadelphia, PA 19153

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Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

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