eCTD regulatory submission-Things need to consider before going for an electronic submission
- Basic information about the eCTD
- Understand the structure and the technical aspects of eCTDs
- Regulatory strategy facing technical issues
- Tips and tricks for successful eCTD submissions
- Best practices to leverage within MS Word and Adobe Acrobat to produce files for eCTD submissions
People who are working in Regulatory Affairs, Documentation, IT, Project management
Experienced Global Regulatory Affairs professional having eight years of experience in Regulatory and Compliance in Pharmaceutical Industries. Expertise on registration of pharmaceutical products in worldwide Health Authorities. Experience in pharma project management from the development of pharmaceutical products till submission to different regulatory bodies for registration of products in different countries. Skilled in electronic Common Technical Document (e CTD) Requirements for Registration of ‘Pharmaceuticals for Human Use (ICH)’ and the various regional authorities.
Well exposure to EMEA guidelines, ICH, USFDA, WHO and various ROW country-specific guidelines and their implementation Knowledge of 21 CFR Part 11, GMP, GxP, GCP guidelines
Specialties: Global Regulatory Affairs, Project Management, Regulatory Compliance, Life-cycle Management, CMC Writing & Review, CTD filling (Paper filling), eCTD filling(electronic submission), SOP & workflow writing and Review, Regulatory Liasion.
Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant eCTD submissions. This begins with understanding what will be accepted and what will not. Put yourself and your company a step ahead of competitors by understanding the technical skills and regulatory requirements necessary to meet the impending eCTD mandates.
- Pre-requisites of Electronic Submission
- Details about DUNS no. ,Labeller code, Digital certificate
- Electronic Submission Gateway (ESG), WebTrader Account
- Best practice for document authoring for Electronic Submission
- QC checklist for eCTD submissions
- Speaker: RAJIB KUMAR BAISHNAB
- Webinar Code: RAJI-0001