Post-Graduate-Diploma-in-Advanced-clinical-research-pharmacovigilace
  • Classroom teaching by eminent faculty involving lectures, PowerPoint presentations and handouts.
  • Stimulated situations and role-plays to give students an insight into understanding of responsibilities of various professionals involved in Clinical Research.
  • Video films on actual situations in Clinical Research.
  • Assignments are given to students which include preparation of CRFs (Case Record Forms), IC (Informed Consent Forms), PIS (Patient Information Sheets), Protocol Designing, PMS (Post-Marketing Surveillance Studies), Plan Designing.
  • Case Studies are given to acquaint the students of real-life Clinical Research situations and are asked to draw inferences and make suggestions.
  • Exercises are given to students where in data on Toxicology, Bioavailability, Bioequivalence is made available to the students and inferences, graphs and calculations are drawn from the same. Exercises are also in the form of MCQs (Multiple Choice Questions), Q/A (Questions & Answers), and report writing.
  • Workshops are conducted for students to emphasize on problem-solving through interaction and exchange of information.
  • Students have access to Institute’s computer and Internet facilities, enabling them in data searches and computer-aided decision making.
  • Students have access to the well-stocked library on Clinical Research with latest books, periodicals, newspapers, journals, prints and records are available for reading and references.

Visits to Facilities/Institutes

Pre-clinical Site Visits

It’s a known fact that preclinical work sets up the base line for any clinical trial process. It is important for the people of the Clinical Research industry to know how, where, when and in what conditions the animal trials are conducted.

Students are taken on a visit to the Institute for toxicology studies where they are able to see a wide range of toxicological studies performed for pharmaceutical, agrochemical, and biotechnological and chemical industries from private and public sectors.

Bio Availability/Bio Equivalence Study Centers

BA Studies are required at the early stages of product development to compare different formulations of the same drug, to find formulation performance of drugs used in clinical trials and demonstrate safety and efficacy, before marketing a drug product. BE Studies are required to establish links between early and late clinical trial formulations, formulations used in clinical trial and stability studies, if different and clinical trial formulations and to-be-marketed drug product.

Clinical Trials Centers

Students are taken for visits to various centers where Clinical Trials are being performed to give them hands-on understanding of clinical trials process, and the roles & responsibilities of various professionals involved in Clinical Trials.