Post Graduate Diploma in Pharmacovigilance (Duration 1 month or 3 months)

                In this course students will learn end-to-end principles and process involved in pharmacovigilance, this training is completely aligned to company standards. In this training program maximum emphasis is given on thousands of approved drugs and possible adverse events, including practice sessions on artificial safety database using various types of safety report forms. Short-term training course on pharmacovigilance is offered for 1 or 3 months. Long term course is offered as combined course (6 months) of CDM or medical writing with PV.

Topics:

• Pharmacovigilance overview

• Good Pharmacovigilance Practices

• Handling serious and non-serious cases

• Seriousness assessment

• SAE reconciliation

• MedDRA and WHO coding

• Argus safety database

• Case processing

• Narrative writing

• Aggregate reporting

Post Graduate Diploma in Clinical Data Management (Duration 1 month or 3 months)

           This course allows students to learn complete process and steps involved in clinical data management including basic principles and definitions. This training program will mainly focus on theoretical and fundamental aspects of clinical data management including clinical trial design, statistical analysis plan, basics of statistical analysis using SAS program, and reporting of study outcome to regulatory authority. Short-term training course on CDM is offered for 1 or 3 months. Long term course is offered as combined course (6 months) of PV or medical writing with CDM.

Topics:

• Drug discovery and development

• BA/BE studies

• Clinical trial phases and study design

• ICH-GCP

• Informed consent form

• Ethics

• Protocol and IB

• Roles and responsibilities of sponsor, CRA, CRC, etc.

• Global regulatory authorities

• Audits

Post Graduate Diploma in Medical Writing (Duration 1 month or 3 months)

               In this comprehensive course students will be trained on preparation of clinical evaluation reports on specific medical device for regulatory submission. This training course includes basic and advanced literature search strategy, literature selection strategy, table/flowchart preparation, and risk-benefit analysis and outcome reporting. Key focus of this training is to upgrade student’s writing skills relevant to regulatory submissions for medical device and drug manufacturing industry. Short-term training course on medical writing is offered for 1 or 3 months. Long term course (6 months) is offered as combined course of PV or CDM with medical writing.

Topics:

• Aggregate reporting for drugs

• PSUR

• DSUR

• PADER

• PBRER

• Clinical evaluation reports for devices

• Statistical planning

• Systematic literature review

• ISO 13485 and ISO 14155

• Risk-benefit analysis

Advanced Post Graduate Diploma in Clinical Research (1 year course)

This advanced course is designed for freshers and undergraduates to learn clinical research from beginning to the end. This course is particularly designed to educate students about diseases, drugs, databases, advanced analytics, publishing and writing technical regulatory documents.

Module 1: Pharmacovigilance and Materiovigilance. (Duration 2 month).

Module 2: Clinical study design. (Duration 1 month).

Module 3: Clinical data management. (Duration 1 month).

Module 4: Clinical statistics. (Duration 3 months).

Module 5: Evidence based practice (Duration 3 months).

Module 6: Medical writing (Duration 2 months).

This program includes theory and practical classes for all above mentioned modules, one group publication, and placement assistance. 

Eligibility

           Students graduated from any government approved college or university can apply for this course. Students about to complete or recently completed B.Sc. or M.Sc. from any life science stream such as zoology, botany, biotechnology, biochemistry, microbiology and chemistry. Engineering students from B.Tech or B.E. in Biotechnology or chemical engineer can take this courses. Healthcare professionals such as BPT, nursing, B.Pharm, M.Pharm, and PharmD, are eligible to take our courses for job oriented skill development. Students in their final year of degree program can join the training program at Vero clinical research institute. In order to take deeper insight into drug development, life science graduates are encouraged to take long-term courses. Physicians pursuing MD course, aspirants of higher study in abroad can receive publication support on evidence based practice or observational studies with our expertise.