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Saturday, June 24, 2017
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Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form (PRA03)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
CPD Accredited TrainingAccreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 1.5
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00

dinaris.org LogoTraining Program: Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

The Common Technical Document (CTD) is the mandatory format for regulatory submissions in Australia, Canada, Japan, the European Union, and, for the United States of America, it is strongly recommended. It is widely accepted elsewhere, as well. This class explains the rationale for the Common Technical Document and provides detailed guidance on its format and structure. Related documents such as Certificates of Suitability and Drug Master Files are also discussed.

This course discusses the regulatory approval of the Common Technical Document, the use of the Common Technical Document and its structure, and the conversion of other formats to Common Technical Document.

A passing grade of 80% or more is required. Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade.

Benefits of Getting Certified at dinaris.org

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the dinaris.org provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The dinaris.org also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form Course is Found in the Following Professional Certification Program(s):


International Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ … Learn more

Essentials in US Regulatory Affairs Professional Certification Program: This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the ‘NDA Process’. The program describes preparing submissions using the Comm … Learn more

COURSE OUTLINE:


Regulatory Approval and the CTD
This part explains the rationale for the CTD, including information on the ICH and EU, US and Japanese regulatory authorities. It also gives information on full and abridged/abbreviated applications.

Use of the CTD
This part explains the format, data requirements and limitations of the CTD, differences between the EU and USA and how to get guidance from the ICH, US, EU and Japanese regulatory authorities. Information is also provided on drug master files, certification of suitability, formatting and updating the dossier.

Structure of the CTD
This part explains what should be included in the five modules of the CTD from an EU, US and Australian perspective.

Conversion of other Formats to CTD
Two tools are provided to assist with obtaining CTD section codes and headings from the old EU NTA format and US FDA NDA format.

COURSE OBJECTIVES:


Students completing this course should be able to:

–Describe the structure and format of the CTD and appreciate the rationale for it.

–Explain how to prepare submissions to regulatory authorities in all countries or regions where the CTD format is mandatory, recommended or accepted.

–Understand the differences between EU and US requirements and how to get guidance from the ICH and other regulatory authorities.

–Specify how to convert EU NTA and US FDA NDA formats to CTD section codes and headings.

JOB POSTINGS:

313 Regulatory jobs found.
Displaying jobs #1-4.

Regulatory Reporting Specialist
Posted Date: 2017-06-23
COOK MEDICAL – United States, IN, Bloomington, 47404

Clinical Research Regulatory Affairs Manager
Posted Date: 2017-06-19
Medix – United States, WA, Seattle, 98127

Regulatory Compliance Analyst
Posted Date: 2017-06-19
Apex Life Sciences – United States, MD, Rockville, 20849

Associate Director Regulatory Affairs CMC
Posted Date: 2017-06-21
Ascent Life Sciences – United States, MA, Waltham, 02254

See more Regulatory Jobs


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