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
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