eCTD Submissions 2018 – Common Technical Document Guidelines

Start Date : April 5, 2018
End Date : April 6, 2018
Time : 9:00 am to6:00 pm

Phone : (800) 447-9407
Email : support@globalcompliancepanel.com

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

 

Overview:

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. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

 

Why should you attend:

 

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.

 

Areas Covered in the Session:

 

 

Who will benefit:

 

 

 

Agenda:

 

Day 1 Schedule

 

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:

Implementing tools for the project management of CTD preparation and publishing

Lecture 6:

Technical requirements for an eCTD submission

Day 2 Schedule

 

Lecture 1:

Document naming requirements

Lecture 2:

Building the folder structure

Lecture 3:

Performing “pre-publishing” work for each document

Lecture 4:

Tools for tracking and managing eCTD content

Lecture 5:

Performing quality checks on the eCTD

Lecture 6:

Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)

 

 

 

Speaker

Peggy Berry

President/CEO, Cooke Consulting Inc. 

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).

 

 

Location:  Baltimore, MD Date: April 5th & 6th, 2018 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON   Baltimore, MD

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until February 28, Early Bird Price: $1,295.00 From March 01 to April 02, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees   Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

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For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link – https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901660SEMINAR?SEO

 

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GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

Tel: 800-447-9407
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/


Event Categories: Health & Nutrition.

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