Best Clinical Research Institute with all INDIA Branches

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Biotechnology & Pharmaceutical Center

Indore Region
Call 9271119646 | Email cr.indore@mitconindia.com
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Join Advanced PG Diploma Course in Clinical Research in Indore

Become an expert in Clinical Research with the Advanced PG Diploma in Clinical Research Course offered by MITCON’s Clinical Research Institute in Indore. 

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Advanced PG Diploma in Clinical Research​

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Feel free to reach out using the below details.

Address: C/o. Awfis Space Solutions Pvt. Ltd., 2nd floor, Winway world offices, PU-4 Scheme No. 54, Vijay Nagar, Indore (MP) 452010

Phone: 9271119646

Email: cr. indore@mitconindia.com

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Course

content

Clinical Research Operations

Module 1

  • ICH-GCP Guidelines
  • New Drug & Clinical Trials Rules
  • TMF/eTMF
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Clinical Data Management (CDM)

Module 2

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

Module 3

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

Module 4

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

Module 5

  • Regulatory Agencies
  • Common Technical Documents – CTD (API & Formulation)
  • Introduction to eCTD
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Interpersonal Skills

Module 6

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