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

01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Listen From Peggy J. Berry she is President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development"

Assure compliance with CDISC requirements?

Description

This course will introduce you with a current thinking of the Food and Drug Administration (FDA or Agency) on the topic and provide you with useful specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

Why should you attend:

Despite there being extensive information available from FDA and other regulatory bodies regarding eCTD submission, creating one and submitting it through the electronic submission gateway (ESG) of the FDA, is a daunting task even for those proficient in computer systems and coding languages. The off-the-shelf software and consultations available are prohibitively expensive not only in the capital investment required but also in terms of the time needed for getting a submission ready.

Learning objectives:

•       What are the requirements for electronic datasets in eCTD submissions?
•      Where are the contents of clinical datasets located in the eCTD structure for: tabulation datasets, analysis-                ready datasets and programs, and patient profiles?
•       What approaches should be taken to assure submission-readiness of datasets?
•       How can the datasets package be remediate for submission if the deliverables are not submission-ready?
•       What is the impact of CDISC and what steps should be taken now to assure compliance with CDISC                           requirements?
•       What steps should be taken if electronic datasets are not available?

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
•       Implementing tools for the project management of CTD preparation and publishing
•       eCTD Guidance and Specifications, FDA

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 

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Peggy J. Berry, MBA, RAC

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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