ComplianceOnline

The common technical dossier - guidance on writing the overviews and summaries

Instructor: Paul Sugden
Product ID: 700235
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

The seminar will address the compilation of Marketing Authorisation applications in the EU in accordance with the Common Technical Dossier (CTD) format.

Description

The importance of organizing documents to comply with the format within company’s R&D departments will be discussed

The pivotal nature of the Quality Overall Summary, preclinical and clinical overviews will be addressed. Some examples of what type of information needs to be included in the overviews will be provided to illustrate this.

Areas Covered in the seminar:

  • Organisation of the CTD – comparison with old MAA and NDA formats
  • CTD Summaries and overviews
  • Quality Overall Summary (QOS)
  • Nonclinical Overview and Summaries
  • Clinical Overview and Summaries

Who Will Benefit:

  • Regulatory Affairs staff
  • Medical and preclinical writers
  • Documentation specialists
  • Authors of development and validation reports in pharmaceutical development and production groups

Instructor Profile:

Paul Sugden has worked in European Regulatory Affairs for over 25 years, and has been closely involved in the preparation of regulatory submissions for a wide range of products. He has worked for multinational pharmaceutical companies, consultancies and small UK based biopharmaceutical companies. He currently is Director of Regulatory Affairs for PDS, a growing UK based consultancy in Pharmaceutical Development, technology transfer, quality management and regulatory affairs for the multinational pharmaceutical industry. PDS has been involved in the compilation of a number of dossiers in the CTD format, and has also reformatted several major dossiers to conform to the CTD.

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