MEDICAL WRITING COURSE AND TRAINING, CERTIFICATE.
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Course Duration: 24 hrs. classroom, 30 to 40 hrs. assignments in 8 days / 2 months at part-time weekends only.
Course Level: With Practical Assignments, 100% Industry Working Faculty.
Prerequisites: Basic English, Knowledge of Clinical Research
Course Content:
- Introduction to Medical Writing,
- Phases of Clinical trials and Study Designs,
- Basic Statistics, Medical Writing style guide,
- Patient Narratives, Clinical Investigator Brochure,
- Clinical Study Report, Clinical Study Protocol
- PSUR, Clinical Trial Registry Summary,
- ISS and ISE, CTD/eCTD, Manuscripts, and Journal publication
Clinical Research Course, Training, Certificate.
Course Duration: 3 Months (24 hrs. classroom and 30 to 40 hrs. self-study for assignment)
(Class room/ online/ Correspondence)
Course Fees: Rs. 25000/- (Inclusive taxes, study material)
Eligibility: Undergraduates, Graduates and Post Graduates in Science, Pharmacy, Medicine, Nursing, Management, practicing and working Doctors, Pharma Executives
Course Content:
- Module 1- Phases Of Clinical Trial
- Module 2- Ethics In Clinical Research
- Module 3- Clinical Operations
- Module 4- Clinical Data Management
- Module 5- Pharmacovigilance
- Module 6- Medical Writing
- Module 7- Regulatory Affairs
- Module 8- Audit & Monitoring
- Module 9- Soft Skill & Interview Preparation
Customized Selected Modules Course is also available for eligible students.
REGULATORY AFFAIRS COURSE, TRAINING, CERTIFICATE.
Course Duration: 3 Months (24 hrs. classroom and 30 to 40 hrs. self-study for assignment) (Class room/ online/ Correspondence)
Course Fees: Rs. 25000/- (Inclusive taxes, study material)
Eligibility: Undergraduates, Graduates and Post Graduates in Science, Pharmacy, Medicine, Pharma Executives
Prerequisites: Basic English, Basic Knowledge of Pharma Industry
Course Level: With Practical Assignments, 100% Industry Working Faculty.
Course Content:
- GMP, Quality Assurance, GLP
- Method, Process & Cleaning Validations
- Deviation management, CAPA
- CTD & e CTD, Dossier
- Audits & Inspections by Different Regulatory agencies
- Regulatory Compliance for WHO & ICH Guidelines
- Regulations for Pharma Research
- TQM – Concepts & Execution
QUALITY SOLUTIONS
Neel Residency 2 CHS, G-102, Plot 34, 48-51, Sector 3, Opp. Dwarka Sweets, New Panvel, Raigad, Maharashtra 410206 India
ph: 91-9820960304
info@qualitysol.in , awww.qualitysol.in