Advance PG Diploma in Clinical Research
Module 1: Clinical Research Operations
- ICH-GCP Guidelines
- New Drug & Clinical Trials Rules
- TMF/eTMF
Module 2: Clinical Data Management (CDM)
- Introduction to CDM & Process flow of CDM
- Data entry & Database
- Data review & Essential documents in CDM
Module 3: Pharmacovigilance
- Introduction to Pharmacovigilance
- Eudravigilance & Signal Detection
- PSUR & CIOMS/MedWatch
Module 4: Medical Writing
- Introduction to Medical Writing & Protocol Writing
- IB & ICD Writing
- Manuscript & Publication Writing
Module 5: Regulatory Affairs
- Regulatory Agencies
- Common Technical Documents - CTD (API & Formulation)
- Introduction to eCTD
Module 6: Interpersonal Skills
- Soft Skill Development & Presentation Skills
- CV Preparation / Writing
- LinkedIn Profile Creation & Networking
Fees & Duration
- Fees:- 85,000/- INR
- Duration:- 6 Months
Main Branch
MITCON Biotechnology & Pharmaceutical Technology Business Incubator Center
New Agriculture College Building,
Campus, Near DIC Office, Narveer Tanaji Wadi,
Shivajinagar Pune, MH - 411005
: 020 6628 9451/52
: +91 83088 09266
: biopharma@mitconindia.com
: 020 6628 9451/52
: +91 83088 09266
: biopharma@mitconindia.com
Mumbai (Thane)
MITCON Biotechnology & Pharmaceutical Technology Business Incubator Center
Ascend Cowork,
1304, Dev Corpora,
Eastern Express Highway,
Thane – 400601
: +91 70580 53870
: nisha.baraiya@mitconindia.com
: +91 70580 53870
: nisha.baraiya@mitconindia.com
Mumbai (Andheri)
MITCON Biotechnology & Pharmaceutical Technology Business Incubator Center
Ascend Cowork,
B 205/206, Dhanashree Heights
Veera Desai Road, Azad Nagar,
Andheri West, Mumbai - 400053
: +91 89562 59019
: maclina.cardoz@mitconindia.com
: +91 89562 59019
: maclina.cardoz@mitconindia.com
Mumbai (Vasai)
MITCON Biotechnology & Pharmaceutical Technology Business Incubator Center
Dfactory,
1st floor, Cabin no 15
Swaminarayan building, above IDBI bank,
60ft road, Vasai(W)-401202
: +91 74107 86203
: meet.gandhi@mitconindia.com
: +91 74107 86203
: meet.gandhi@mitconindia.com