Certification Course in Drug Regulatory Affairs (Recorded)

Self-paced recorded RA programme

Self-paced recorded programme. After payment you will receive the access link on the thank-you page and in your email.

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

• Instant recorded access after purchase
• Core RA syllabus
• Certification Provided
• Placement assistance