Advance Certification Course in Drug Regulatory Affairs (Live)

Live Weekend Batch with 100% Placement Assistance

Live enrollment. After payment our team will contact you for live sessions.

Syllabus

Module 1: Regulatory Affairs introduction & Overview of Regulatory Affairs Departments and main responsibility
Module 2: CTD Introduction - Module 1 to 5
Module 3: ICH – Introduction, Objectives & Guidelines Q1-Q14 ICH – Introduction, Objectives & Guidelines Safety ICH – Introduction, Objectives & Efficacy, Multidisciplinary Guidelines
Module 4: Chemistry, Manufacturing & Controls (CMC) & Drug Master File Introduction to Regulatory Affairs, Terms & terminologies & Abbreviations Drug Development Process & Introduction to Clinical Research
Module 5: Indian Pharmaceutical Regulations Regulatory Filing Systems in US Regulatory Filing Systems in Europe, UK, Canada Registration Procedures in Rest of the World (i.e GCC, LATAM, ASIA, APAC)
Module 6: Practical Approach towards Overall Dossier Preparation & Submission Pre Publishing Publishing
Module 7: Final Submission via Gateways based on country Final Submission via Gateways ROW Lorenz Validations
Module 8: Audits & Compliances Regulatory Operations Pharmacovigilance Regulations

Benefits

1) Certificate from ISO certified organization
2) Expert learning
3)Recorded lectures
4)Domain knowledge
5)Placement assistance
6)Soft skill development
7) Hands on CTD dossier
8) Submission practice