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6 Months. Advanced Job Oriented Post Graduate Diploma in 6 Modules. Offline

Duration: 6 Months (Theory, Practical’s and Internship)
Mode of Training: Offline
Modules: 6 Modules
Free Add-on Courses: 2 Free Add on Course with Certificate (Student’s Choice)
Internship: 3 Months Free Internship with Certificate
Certificates: Total 4 Certificates
Trainers: Satish Kumar, Ram, Kavitha, Vinay, Veena and Rohini (Corporate Employees)
Students have learned: 500+
Review:
Fee: 46000-50000 ₹ 70000 Save ₹ 24000/-
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Course Details

Clinical Research, Pharmacovigilance, Clinical Data Management, Regulatory Affairs, Medical Writing, Medical Devices & IVD. Communication Skills, Interview Preparation, Resume Writing, Mock Interviews, Group Discussions, Guest Lectures, Professional Email Writing, Naurki and Linkedin Profile Setting.

Free Access to Mobile Application.

Certification

4 Certifications

Industry-Recognized & Central Government (LSSSDC & Skill India) Approved

  • Certificate in Advanced Job Oriented Training in 6 Clinical Research Modules by clinOXY, LSSSDC & Skill India
  • Free Add on Course Completion Certificate by clinOXY, LSSSDC & Skill India
  • 2 Free Add on Course Completion Certificates by clinOXY, LSSSDC & Skill India
  • Total 4 Certificates

Who this course is for

Fresher’s and Working Employees from B.Pharmacy, M.Pharmacy, Pharm.D, Biotechnology, Microbiology, Chemistry, MBBS, Nursing, Dental, Physiotherapy and Agriculture.

What you'll learn in this course:

Clinical Research

  • Module I – Introduction to Clinical Research
  • Module II – Fundamentals of Biostatistics
  • Module III – Clinical Trial Design and Methodology
  • Module-IV – Good Clinical Practice (GCP) Guidelines
  • Module V – Site Selection and Protocol Preparation
  • Module VI – Patient Recruitment and Selection
  • Module-VII – Clinical Research Ethics
  • Module VIII – Data Management in Clinical Research
  • Module IX – Process of conducting trials
  • Module IX – Process of conducting trials

Pharmacovigilance

  • Module I – Introduction to Pharmacovigilance
  • Module II – Basic Principles of Pharmacology
  • Module III – Regulatory Frameworks in Pharmacovigilance
  • Module-IV – Case Processing and Case Narratives
  • Module V – Adverse Event Reporting and Management
  • Module VI – Pharmacovigilance in Clinical Trials
  • Module-VII – Pharmacovigilance Communication and Interactions
  • Module VIII – Pharmacovigilance in Special Populations
  • Module IX – Signal Detection and Management Module X – Emerging Trends and Technologies in Pharmacovigilance
  • Module X – Emerging Trends and Technologies in Pharmacovigilance

Clinical Data Management

  • Module I – Introduction to Clinical Data Management (CDM)
  • Module II – Clinical Trial Lifecycle and Data Flow
  • Module III – Study Start up, Study Conduct and Study Lock
  • Module-IV – Database Design and Development
  • Module V – Data Validation and Cleaning
  • Module VI – Data Entry and Quality Control
  • Module-VII – Electronic Health Records (EHR) and Real-World Data (RWD)
  • Module VIII – Quality Assurance and Audits in Data Management
  • Module IX – Data Privacy and Regulatory Compliance
  • Module X – Emerging Trends and Technologies in Data Management

Regulatory Affairs

  • Module I – Introduction to Regulatory Affairs
  • Module II – Global Regulatory Requirements
  • Module III – Regulatory Submissions and Applications
  • Module-IV – Good Regulatory Practice (GRP)
  • Module V – Pre Approval and Post Approval Documentationta Validation and Cleaning
  • Module VI – Pharmaceutical Development and Manufacturing
  • Module-VII – Orange Book, Purple Book and IID Database
  • Module VIII – Post-Marketing Regulatory Activities
  • Module IX – Regulatory Compliance and Enforcement
  • Module X – Emerging Trends and Technologies in Regulatory Affairs

Medical Writing

  • Module I – Introduction to Medical Writing
  • Module II – Scientific Writing Principles
  • Module III – Literature Search and Review
  • Module-IV – Medical Writing for Regulatory Documents
  • Module V – Clinical Trial Protocols and Reports
  • Module VI – Manuscript Writing for Journals
  • Module-VII – Medical Writing for Regulatory Submissions
  • Module VIII – Writing for Medical Education and Communication
  • Module IX – Editing and Reviewing Techniques
  • Module X – Disease Write up’s, Medical Communications

Medical Devices & IVD

  • Module I – Introduction to Medical Devices & IVD
  • Module II – Classifications and Risk Assessment
  • Module III – EU-MDR, EU-IVDR and IMDR Regulations
  • Module-IV – Good Regulatory Practice (GRP
  • Module V – Quality Management Systems (QMS) for Medical Devices and IVDs. ISO 13485:2016
  • Module VI – Product Development and Design Controls
  • Module-VII – Clinical Evaluation and Performance Studies
  • Module VIII – Labeling and Packaging Requirements
  • Module IX – Regulatory Submissions and Applications
  • Module X – Post-Market Surveillance and Vigilance

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Do you still have any questions?

Don't hesitate to leave us your phone number. We will contact you to
discuss any questions you may have

Do you still have any questions?

Don't hesitate to leave us your phone number. We will contact you to
discuss any questions you may have

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