Overview and Introduction of RA and RO

• Regulatory Affairs and Regulatory Operations professions
• Structure of Pharma industry and its functioning
• Origin of Regulatory Operations profession from Regulatory Affairs
• Why and When RO professional required in pharma industry?
• Overview of Regulatory agencies (ICH, US-FDA, EU-EMA and HC-Canada, GCC-Gulf Countries etc…)
• Industries i.e. Pharmaceutical, API, Biologic and Medical Device
• Introduction of Regulatory Publishing for various dosage form and submission and applications (IND, ANDA, NDA, BLA, DMF, ASMF, ANDS, NDS, SANDS, MAA etc…)
• Critical role of RO professional specialist in a successful eCTD submission

Introduction of CTD, NeeS and eCTD

• What is CTD / Paper dossier
• Origin of NeeS and eCTD format
• What is eCTD and Its importance and Advantage
• Basic Difference between pCTD, NeeS and eCTD format
• Countries accepting submission eCTD and NeeS format
• Differences & essential requirement of countries for eCTD and NeeS
• Four Arms of eCTD (Submission Management, DLP, SLP and Submission Dispatch, Archival and Troubleshooting)
• Current trend and future of eCTD (eCTD v4.0)
• Risk level in eCTD Publishing and how to ensure successful submission
• Health Authorities filling review Do’s and Don’ts (optimizing eCTD)
• Project Management strategies for successful eCTD submission

Technical understanding of eCTD and NeeS

• Role of XML backbone, ToC backbone, directory structure, PDF files, util folder, index-md5 in eCTD
• Role of Submission Attributes (Regional and ICH metadata)
• Providing Regulatory Submissions in Electronic Format – eCTD Specifications for USFDA
• Regulatory Publishing requirement and system in US, EU and Canada
• GDUFA II impact on eCTDs with relevant case studies
• Module 1 specifications all eCTD accepting countries (US, EU, Canada and Gulf countries)
• ICH guidelines and related regulatory authority specific guidelines (eCTD Specifications 3.2.2, M2, M4 and M8) requirements and standards
• eCTD Technical Conformance Guide for USFDA
• ICH STF Specification for USFDA and Canada
• File format and PDF specification for all eCTD accepting countries
• Specifications for eCTD Validation Criteria for all eCTD accepting countries
• Submission Transmission Specifications for all eCTD accepting countries
• Type of applications, procedures, submissions, sub-submission for all eCTD accepting countries
• Technical Rejection Criteria for Study Data for USFDA
• Study data technical conformance guide for USFDA
• FDA Guidance for Data Standards Catalog
• Concept of DST (day light saving time)
• Submission gateways (ESG, CESP, ESubmission) and their procedure
• Concept of ESG acknowledgements for USFDA and Canada
• Concept of CESP submission to European agencies
• Concept of document life-cycle operations (new, append, replace and delete)
• How Create an ESG Account and how to secure mail with FDA
• Concept of Leaf Title for all eCTD accepting countries
• Concept of Study Tagging Files for dataset files for Module 4 and 5
• Different types of submissions (Pre-approval & Post approval) for US, EU, Canada and Gulf countries
• Trick to submit high quality eCTD submissions to Health Authorities
• IT Consideration in Regulatory Publishing

Theoretical Training of eCTD Software and QC Checklist

• Tools required for eCTD Publishing and their Overview
• Detail review of eCTD submission using eCTD Quality Checklist
• To do eCTD submission – thing needs to consider and remind

Hands on Practical Training for eCTD Tools

• Introduction of RO Publishing tools
• Detail practical training of Acrobat Professional with PDF Tools functionality
• eCTD Software and it’s functionality (application / sequence creation, metadata creation, file uploading with Life-cycle management, XML Compilation of sequence) for US, EU, Canada and GCC
• Detail execution of eValidator with resolution of all errors and warnings as per eCTD validation criteria of US, EU, Canada and GCC,
• Detail execution of submission gateway (ESG and CESP) with concept (Planned Outage, DST concept)
• Role of eCTD Submission Schedule Tracker and eCTD QC Checklist, eCTD Tracker for RO professional with practical execution
• Thing needs to remind during eCTD compilation