MITCON Biopharma

Ideal Job oriented Clinical Research course

Advanced PG Diploma in Clinical Research

MITCON's Technology BUSINESS INCUBATOR is sponsored by the Department of Science and Technology (DST), Govt. of India & APCTT, New Delhi. It is also approved by the Ministry of Micro, Small and Medium Enterprises (MSME), Govt. of India. An integrated project having state of art Biotechnology laboratory, consultancy wing, and training facility for various disciplines in Bio-Technology, agriculture, food processing, and Pharmaceutical has been set up to boost commercialization through incubation.

The Center houses facilities for Microbiology, Biofertilizers, Biopesticides, Genomics, Plant Tissue culture sale and supply center, Bioinformatics laboratories. MITCON's Incubation facility is located in the central part of Pune city.



6-in-1 Course Suitable for Life Science, Pharmacy & Medico Graduates

Clinical Research Operations

Course modules based on various Clinical Research Operations

Clinical Data Management

Course modules based on various Clinical Data Management Methods

Pharmacovigilance

Course modules based on various Good Pharmacovigilance Practices

Medical Writing

Course modules based on various Medical Writing Practices

Regulatory Affairs

Course modules based on various Regulatory Affairs Standards

Interpersonal Skills

Course modules based on various Interpersonal Skills Development

Course Facts

20+

Years of Experience


50+

Batches Completed


1500+

Candidates Trained


95%

Placement Ratio


Course Overview

Clinical Research Institute in Pune

Objectives


Provide participants with a broad understanding of the basic principles employed in diploma clinical research both domestically and internationally.

Duration


6 Months (Weekend Batch: Sat & Sun )

Eligibility


MBBS / BDS / BAMS, BHMS /B.PHARM, M. PHARM / B.Sc, M.Sc (LIFE-SCIENCES, BIOTECH, NURSING)

1. Clinical Research Operations:


  • ICH-GCP Guidelines
  • New Drug & Clinical Trials Rules
  • TMF/eTMF

2. Clinical Data Management (CDM):


  • Introduction to CDM & Process flow of CDM
  • Data entry & Database
  • Data review & Essential documents in CDM

3. Pharmacovigilance:


  • Introduction to Pharmacovigilance
  • Eudravigilance & Signal Detection
  • PSUR & CIOMS/MedWatch

4. Medical Writing:


  • Introduction to Medical Writing & Protocol Writing
  • IB & ICD Writing
  • Manuscript & Publication Writing

5. Regulatory Affairs:


  • Regulatory Agencies
  • Common Technical Documents - CTD
  • (API & Formulation)
  • Introduction to eCTD

6. Interpersonal Skills:


  • Soft Skill Development & Presentation Skills
  • CV Preparation/Writing
  • LinkedIn Profile Creation & Networking



Testimonial

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Preferred Location: Pune - Shivajinagar

Contact Details

Pune (Shivajinagar)


 +91 83088 09266

 biopharma@mitconindia.com
 New Agriculture College Building Campus, Near DIC Office, Narveer Tanaji Wadi, Shivajinagar, Pune (MH) - 411005