Vocational

Course details

Vocational pharmaceutical issues, medical, clinical trials, stability and bio equivalence studies and other vocational training workshops is also our added value

Workshop on Implementation of CTD

International conference on harmonization-Common technical document (ICH-CTD)

General Standard Saudi food & drug administration (SFDA)?& CTD General Standard EU

Who should attend

This course is intended for regulatory, export, quality assurance, quality control and research and development personal in the pharmaceutical and related industries.

Learning objectives:

Upon completion of this course, you will have gained an understanding of the concept and rules of Registration Process, Structure and Content of Submission, Presentation of the Product File. A concise overview of the scientific data requirements for obtaining a marketing authorisation in the European Union (EU) .Introduction on Human Pharmacovigilance. How to ensure that the information on the labelling and package leaflet is accessible to and can be understood by those who receive it, so that they can use their medicine safely and appropriately.

Course description:

Registration Process, Structure and Content of Submission , Presentation of the Product File . Modules (m1 – m2 – m3 – m4 –m5 ) . Hyperlinks, Validation and Document. Table of Contents (ToCs) formatting. Dossier , Portable Document Formatting (PDF), Inquiries and submission ( Add , Append , Delete , Modify) .Time Frame - Life Cycle - Regulations .Navigation – Stop-clock – Authentication . Granularity (Numbering - Section – Extensible Section) . Document Requirements. The content of Module 1 SFDA & EU . A concise overview of the scientific data requirements for obtaining a marketing authorisation in the European Union (EU) is provided. What is an adverse effect? Why ADRs are important? What is Pharmacovigilance? Why do we need pharmacovigilance? Patient Monitoring Systems . Risk management .The Roles of the Various Parties The Marketing Authorisation Holder . The Competent Authorities. The EU Pharmacovigilance System . Assist applicants and marketing authorisations holders when drawing up the labelling and package leaflet and preparing the mock-ups or specimens of the sales presentations, how to ensure that the information on the labelling and package leaflet is accessible to and can be understood by those who receive it, so that they can use their medicine safely and appropriately.

Course outline:

Day 1

• Introduction to CTD, Common Technical Document From the classical format to eCTD
• CTD General Standard, Presentation and format of the dossier (EU)
• CTD General Standard SFDA, Registration Process , Structure and Content of Submission , Presentation of the Product File , Document Requirements.

Day 2

• CTD Quality Q& A , Definition of a Quality Document.
• Compilation for registration documents for different regions, User Guide for Micro, Small and Medium-sized.
• Human Pharmacovigilance Introduction.
• Communication & Herrmann Whole Brain HBDI

Day 3

• Readability of the labeling, guideline on the readability of the labeling and package leaflet of medicinal products for human use .
• EU CTD Presentation, EU CTD Presentation - Introduction - Presentation and format of the dossier (EU).
• eCTD What . Who . Why , When,How
• Template EU ICH CTD
• Template SFDA m1 CTD