Bengaluru Centre
LSSSDC
Live eLearning PG Diploma
Clinical Research
Pharmacovigilance
Clinical Data Management
Fulltime - 4 Months Live eLearning
Weekend - 6 Months Live eLearning
9500+ Cliniminds Alumni
Eligibility - B.Pharmacy, M.Pharmacy, Doctor of Pharmacy, BSC, MSC, BDS, BHMS, BAMS, B.Tech / M.Tech Biotech, Biomedical, Life Sciences.
Recent Placements
LSSSDC
Live eLearning PG Diploma
Clinical Research
Pharmacovigilance
Clinical Data Management
Fulltime - 4 Months Live eLearning
Weekend - 6 Months Live eLearning
9500+ Cliniminds Alumni
Eligibility - B.Pharmacy, M.Pharmacy, Doctor of Pharmacy, BSC, MSC, BDS, BHMS, BAMS, B.Tech / M.Tech Biotech, Biomedical, Life Sciences.
Program Inclusions
- Live Interactive eLearning Sessions
- Hands on Software Training - Pharmacovigilance Safety Database, Clinical Data Management, eCTD Software.
- Arranging Job Interviews - Campus Placements.
- Dedicated Placement Cell - 360° Placement Support.
- Pre Placement Training - CV Writing, Mock Interviews, English Communication, Aptitude Test Training
- Access to LMS – 24x7 - Recordings, PPT, Notes, eBooks.
Certifications
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1Life Sciences Sector Skill Development Council, NCVET.
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2Advanced PG Diploma – Cliniminds - Program Accredited by Accreditation Council for Clinical Research Education, United States of America.
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3Internship Certification – www.thinki.in
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4ICH GCP Certificate – Cliniminds
Recent Placements
- Drug Discovery
- Overview of Clinical Research
- Regulations & Guidelines in Clinical Research
- Roles & Responsibilities of Key Stakeholders
- Preparation & Planning of Clinical Trials
- Essential Documentation in Clinical Research & Regulatory Submission
- Study Start Up Process
- Clinical Monitoring Essentials
- Compliance, Auditing & Quality Control in Clinical Research
- Overview of Clinical Research
- Pharmacology – General Principles
- Introduction to Pharmacovigilance
- Pharmacovigilance Regulations
- Hands on Training on Case Processing and Report Generation
- Safety Reporting and Processing ICSR
- Aggregate Reports, Signal Detection & Risk Management
- Documents in Pharmacovigilance
- Audits & Inspections
- Advanced Pharmacovigilance & Analytics
- Overview of Clinical Data Management
- Clinical Data Integrity
- Data Management Plan
- Design of Case Report Form
- CRF Tracking
- Electronic Data Capture
- Data Entry Guidelines
- Edit Check Creation, Validation, Programming
- Discrepancy Management
- Data Transfer in Clinical Data Management
- Medical Coding Dictionaries
- Laboratory Test in Clinical Trials
- Creating Reports
- Adverse Event Reporting & Reconciliation
- Audit Trail
- Database Lock
- Quality Assurance in Clinical Data Management
- QMS, Audit & Inspection, SOP Compliance
- Hands on Software Training
- Drug Development Process & Introduction to Clinical Research
- Introduction to Regulatory Affairs, Terms & Terminologies & Abbreviations
- Chemistry, Manufacturing & Controls (CMC)
- Drug Master File
- Regulatory, Filing System for DMF in Different Countries
- ICH – Introduction, Objectives & Guidelines
- CTD Introduction - Module 1 to 5
- Regulatory Filing Systems in Europe
- Regulatory Filing Systems in US
- Registration Procedures in Rest of the World
- Validations
- Audits & Compliances
- Regulatory Operations
- Pre Publishing
- Publishing
- Final Submission via Gateways
- Practical Approach towards Overall Dossier Preparation & Submission
- Pharmacovigilance Regulations
- Indian Pharmaceutical Regulations
- Introduction to Patent Regime
- Introduction to Patents
- Trademarks
- Copyright
- Industrial designs
- Trade Secrets
- Geographical indications
- Types of Patent
- Patentability criteria
- Patentable subject matter/Non Patentable subject matter
- Anatomy of Patent
- Term of a Patent Expiry calculation of patents.
- Inventor ship
- Duty of Disclosure
- Timelines
- Types of Searches
- Various Search Engines
- Performing a Search (Dummy Strategy) & Advantages of patent search
- International Patent classification Patent
- Introduction to patent drafting
- Specification and Description
- Written description, Enablement and Best mode requirement
- Claims
- SAS Introduction
- Infile option
- Methods to read data
- Import Export of data
- Set and where statements
- Libraries
- If then Else statement
- If then and Loop
- Addition of data
- Merging of data
- Functions in SAS
- Procedures in SAS
- SQL Overview
- Macro Overview
- ODS(Output Delivery System)
- Introduction to CDISC
- Overview of CT Protocol, SAP, CRF, TFL shell
- Sample CRF Annotation activity
- Overview of SDTM Implementation guide
- Overview of ADaM Implementation guide
- Preparation of Dataset specification (SDTM + ADaM)
- Sample SDTM creation
- Sample ADaM creation
- Creation of .XPT files for Regulatory submission
- Sample TFLs creation
- Overview of P21 tool for validation of data
- Overview of University free SAS version usage to perform above
- activities on dummy project
- Overview of define.xml and final regulatory submission package
OUR KEY RECRUITERS
For more information, please contact:
Cliniminds Bengaluru
+91-9902261347 , +91-9560102589, +91-9810068241
C/O BHIVE Workspace Platinum Indiranagar, 271, 6th Main Rd, HAL 2nd Stage, Motappapalya, Indiranagar, Bengaluru, Karnataka 560038
Email us your queries : bangalore@cliniminds.com
