IPM has been successfully conducting training programmes in Mumbai, with its presence in Dombivli, Borivali & Vashi.

Salient features are:

• Course curriculum based on current approach of regulatory agencies
• Sunday batches, so good option for working professionals
• Experienced industrial faculties
• User-friendly notes based on current guidelines
• Explanation with case-studies
• Group discussion & Quiz sessions
• Evaluation & certification

Eligibility: Pharma/Science graduates and Post-graduates/ Industry working professionals

Duration: 6 months [Sunday batches]

Course Highlights:
Pharmaceutical Quality System, Indian Pharmaceutical Industry
Regulatory Affairs, Overview of GMP,
Registration requirements of USFDA
ICH Quality guidelines
ICH M4 Q CTD format

DMF preparation: Module 2, Module 3

Regulatory Submission to US

• DMF submission, Common deficiencies, Handling changes

Regulatory submission to Europe

• CEP approval, Module 1, 2 & 3
• Addressing deficiencies, Revisions & renewal
• EDMF/ASMF

WHO, Canada, Japan filing procedures
Dossier preparation in CTD format: Module 2, 3, 4 & 5

Regulatory Submission to US, ANDA approval process, Hatch-Waxman Law

Regulatory Submission to Europe- Marketing Authorisation procedures

• Module 1 & 2, Common deficiencies, Variations

Regulatory Submission to Semi Regulated Markets

• Latin America (Brazil & Mexico)
• ACTD submission, Regulatory Submission to India

eCTD Submissions