Welcoming, everyone! A brief intoroduction about the speakers Mr. Shiv Kumar Somani - Director of Product & Services at Masuu Global Solutions and Dr. Walid Smadi - General Manager at Pharma Consulting Group (Middle East) about their expertise and short notes about the webinar.

Masuu Global based in USA and India, Masuu Global is a specialised service provider in Regulatory Affairs, Publishing, Labelling, Clinical Affairs and Intellectual Property Rights. We are also an abode to software’s for Pharmaceuticals, Biopharmaceuticals, Healthcare and Life Sciences across the globe.

W.S Marketing provides management consulting services especially in the areas of portfolio management, manufacturing, marketing, registration and sales for pharmaceutical companies to help them overcome the challenges within the rapidly evolving global pharmaceutical market

eCTD Global” a sister concern of Masuu Global LLC, Colorado, USA, specialised in Pharma Regulatory eSubmission services (eCTD Publishing) and software (NextGen eCTD) to create, manage, compile, publish, review, validate, archive dossier in eCTD format with maximum Regulatory (Regional and ICH) specifications, validation and compliance.

This question & answer (Q&A) feature allows attendees to ask questions during the webinar, and for the panelists, co-hosts, and host to answer all your questions related to above completed sessions.

Common TechnicalDocuments in electronic format, where XML works as backbone/Table of Content for easy navigation and review. In sample words Electronic CTD = eCTD.

The basic difference between CTD, Nees and eCTD format was the Paper Format, Table of Content (ToC)and XML. Scientifically and technically CTD=NeeS=eCTD are equal. – 5 minutes.

Health Authorities and Industries rapidly moving towards the electronic submission. Regulated countries i.e., USA, EU, Canada, Australia, Switzerland accepting submission in eCTD format only. Emerging countries started (GCC, Jordan, South Africa etc.) or planning to start eCTD submission in upcoming years. – 5 minutes.

This question & answer (Q&A) feature allows attendees to ask questions during the webinar, and for the panelists, co-hosts, and host to answer all your questions related to above completed sessions.

Discussion on eCTD which contains two xml files (regional.xml contains module 1 file and its regional attributes and index.xml contains module 2 to 5 with ICH attributes).

If your company filing or planning to file dossier in eCTD submission for Jordan FDA, you must understand the basic requirements of eCTD, Do’s and Don’ts, which will avoid the rejection of your dossier. – 10 minutes.

On May 01, 2020, Jordan FDA has updated the JORDAN Module 1 eCTD Specification version as 1.1 and Validation Criteria version as 1.1, and it came into force from January 01, 2021. – 15 minutes.

This question & answer (Q&A) feature allows attendees to ask questions during the webinar, and for the panelists, co-hosts, and host to answer all your questions related to above completed sessions.

What are the tricks and tricks to convert your CTD into successful eCTD submission? Proper planning, selection of best eCTD tool, harmonized practices, understand eCTD guidance's and real time case studies etc. – 10 minutes.

These cases are perfectly simple and easy to distinguish. In a free hour, when our power of choice is untrammelled and when nothing prevents our being able to do what we like best, every pleasure is to be welcomed and every pain avoided.

These cases are perfectly simple and easy to distinguish. In a free hour, when our power of choice is untrammelled and when nothing prevents our being able to do what we like best, every pleasure is to be welcomed and every pain avoided.

These cases are perfectly simple and easy to distinguish. In a free hour, when our power of choice is untrammelled and when nothing prevents our being able to do what we like best, every pleasure is to be welcomed and every pain avoided.